Melanoma
Conditions
Keywords
Melanoma
Brief summary
The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the novel triple combinations.
Detailed description
This study consists of two parts: in Part I/Run-In, patients naïve to selective BRAF and MEK inhibitors will be treated with the LGX818/MEK162 combination until disease progression (as defined per RECIST v1.1). Based on the genetic analysis of a tumor biopsy obtained at that time, patients will enter Part II of the study for tailored combination treatment in one of four arms of LGX818/MEK162 + either BKM120, BGJ398, INC280 or LEE011 Patients with BRAF mutant melanoma treated by LGX818/MEK162 combination in other studies can be enrolled directly in Part II of CLGX818X2109 after relapse. Dose-escalations in the combination arms for which no MTD has been established will be based on the recommendations of a Bayesian logistic regression model guided by an escalation with overdose control criterion
Interventions
Combination of LGX818 and MEK162 (Part I)
Combination of LGX818 and MEK162 (Part I)
Combination of LGX818 + MEK162 + LEE011 (Part II)
Combination of LGX818 + MEK162 + BGJ398 (Part II)
Combination of LGX818 + MEK162 + BKM120 (Part II)
Combination of LGX818 + MEK162 + INC280 (Part II)
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥ 18 years * Histologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IIIC to IV per American Joint Committee on Cancer \[AJCC\]) * Documented evidence of BRAF V600 mutation. * Newly obtained tumor biopsy at baseline, and patient agrees to a mandatory biopsy at the time of progression, if not medically contraindicated. * Evidence of measurable disease, as determined by RECIST v1.1. INCLUSION CRITERIA for triple combinations: Progressive disease following prior treatment with LGX818/MEK162 combination. PRINCIPAL
Exclusion criteria
Symptomatic or untreated leptomeningeal disease. * Symptomatic brain metastases. Patients previously treated or untreated for brain metastases that are asymptomatic in the absence of corticosteroid therapy or on a stable dose of steroids for four weeks are allowed to enroll. Brain metastases must be stable at least 4 weeks with verification by imaging (e.g. brain MRI completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs. * Patients who have developed brain metastases during Part I of the study may continue to Part II upon discussion with Novartis Medical Monitor. The brain metastasis must be either asymptomatic or treated and stable for at least 4 weeks and on a stable or tapering dose of steroids for at least 2 weeks. Patients with brain metastasis are not eligible for the combination with LEE011. * Known acute or chronic pancreatitis. * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); * Clinically significant cardiac disease including any of the following: * CHF requiring treatment (NYH grade ≥ 2), * LVEF \< 50% as determined by MUGA scan or ECHO * History or presence of clinically significant ventricular arrhythmias or atrial fibrillation * Clinically significant resting bradycardia * Unstable angina pectoris ≤ 3 months prior to starting study drug * Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug, * QTcF \> 480 msec. Patients with any of the following laboratory values at Screening/baseline: * Absolute neutrophil count (ANC) \<1,500/mm3 \[1.5 x 109/L\] * Platelets \< 100,000/mm3 \[100 x 109/L\] * Hemoglobin \< 9.0 g/dL * Serum creatinine \>1.5 x ULN or calculated or directly measured CrCl \< 50% LLN (lower limit of normal) * Serum total bilirubin \>1.5 x ULN * AST/SGOT or ALT/SGPT \> 2.5 x ULN, or \> 5 x ULN if liver metastases are present Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR): Part II | From the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (maximum treatment exposure for Part II was 97.0 weeks) | ORR: percentage of participants with confirmed complete response (CR) and partial response (PR). Response evaluation criteria in solid tumors (RECIST) v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions that had a reduction in short axis to less than (\<) 10 millimeter (mm). Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis) and b) PR = at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Any radiological assessments taken more than 30 days after the last dose of study therapy or after antineoplastic agents other than study treatments taken by the participants was excluded from the best overall response derivation. Confirmation of CR or PR was to be at least 4 weeks apart from the previous radiological assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) in Cycle 1: Part II | Cycle 1 (21 days following the first dose of the combination treatment with buparlisib and capmatinib; 28 days for the combination with ribociclib and infigratinib) | DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (first 21 days for infigratinib and capmatinib; 28 days for ribociclib and buparlisib) of treatment initiation and met the defined criteria for study. |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Part I | Day 1 up to 30 days after last dose (maximum treatment exposure for Part I was 403.7 weeks) | An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after participants' signed informed consent has been obtained. An SAE was an AE resulting in any of the following outcomes: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. AEs included both SAEs and all Non-SAEs. |
| Number of Participants With AEs and SAEs: Part II | Day 1 up to 30 days after last dose (maximum treatment exposure for Part II was 97.0 weeks) | An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after participants' signed informed consent has been obtained. An SAE was an AE resulting in any of the following outcomes: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. AEs included both SAEs and all Non-SAEs. |
| Actual Dose Intensity: Part II | During study treatment (maximum treatment exposure for Part II was 97.0 weeks) | Dose intensity = cumulative dose/ duration of exposure. Treatment cycle = 21days for the combination treatment with buparlisib and capmatinib and 28 days for the combination treatment with ribociclib and infigratinib. |
| Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Baseline up to last dose (maximum treatment exposure for Part I was 403.7 weeks) | Parameters evaluated were: Activated partial thromboplastin time (APTT) (seconds \[sec\]) - CTCAE graded high, fibrinogen (gram per liter \[g/L\]) - CTCAE graded low, hemoglobin (g/L) - CTCAE graded low, hemoglobin (g/L) - CTCAE graded high, prothrombin international normalized ratio (PINR) - CTCAE graded high, lymphocytes (10\^9 cells/L) - CTCAE graded low, lymphocytes (10\^9 cells/L) - CTCAE graded high, neutrophils (10\^9 cells/L) - CTCAE graded low, platelets (10\^9 cells/L) - CTCAE graded low, leukocytes (10\^9 cells/L) - CTCAE graded low, leukocytes (10\^9 cells/L) - CTCAE graded high. CTCAE version 4.03 was used: grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening consequences; grade 0 = values not meeting any of the criteria for grade 1 or higher. Baseline = last non-missing value prior to the first dose of study treatment. |
| Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Baseline up to last dose (maximum treatment exposure for Part II was 97.0 weeks) | Parameters evaluated were: APTT (sec) - CTCAE graded high, fibrinogen (g/L) - CTCAE graded low, hemoglobin (g/L) - CTCAE graded low, hemoglobin (g/L) - CTCAE graded high, PINR - CTCAE graded high, lymphocytes (10\^9 cells/L) - CTCAE graded low, lymphocytes (10\^9 cells/L) - CTCAE graded high, neutrophils (10\^9 cells/L) - CTCAE graded low, platelets (10\^9 cells/L) - CTCAE graded low, leukocytes (10\^9 cells/L) - CTCAE graded low, leukocytes (10\^9 cells/L) - CTCAE graded high. CTCAE version 4.03 was used: grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening consequences; grade 0 = values not meeting any of the criteria for grade 1 or higher. Baseline = last non-missing value prior to the first dose of study treatment in Part II. |
| Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Baseline up to last dose (maximum treatment exposure for Part I was 403.7 weeks) | Parameters evaluated were: albumin (g/L)- CTCAE graded low, alkaline phosphatase (units per liter \[U/L\])- CTCAE graded high, alanine aminotransferase (U/L)- CTCAE graded high, amylase (U/L - CTCAE graded high, aspartate aminotransferase(U/L)- CTCAE graded high, bilirubin (micromole per liter \[umol/L\])- CTCAE graded high, creatinine (umol/L) - CTCAE graded high, creatine kinase (U/L)- CTCAE graded high, gamma glutamyl transferase (U/L)- CTCAE graded high, glucose (millimole per liter \[mmol/L\])- CTCAE graded low, high, potassium (mmol/L)- CTCAE graded low, potassium (mmol/L)- CTCAE graded high, magnesium (mmol/L)- CTCAE graded low, high, phosphate (mmol/L)- CTCAE graded low, sodium (mmol/L)- CTCAE graded low, sodium (mmol/L)- CTCAE graded high, urate (umol/L)- CTCAE graded high. CTCAE version 4.03 was used: grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening consequences; grade 0 = values not meeting any of the criteria for grade 1 or higher. |
| Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Baseline up to last dose (maximum treatment exposure for Part II was 97.0 weeks) | Parameters evaluated were: albumin (g/L)- CTCAE graded low, alkaline phosphatase (U/L)- CTCAE graded high, alanine aminotransferase (U/L)- CTCAE graded high, amylase (U/L) - CTCAE graded high, aspartate aminotransferase(U/L)- CTCAE graded high, bilirubin (umol/L)- CTCAE graded high, creatinine (umol/L) - CTCAE graded high, creatine kinase (U/L)- CTCAE graded high, gamma glutamyl transferase (U/L)- CTCAE graded high, glucose (mmol/L)- CTCAE graded low, high, potassium (mmol/L)- CTCAE graded low, potassium (mmol/L)- CTCAE graded high, magnesium (mmol/L)- CTCAE graded low, high, phosphate (mmol/L)- CTCAE graded low, sodium (mmol/L)- CTCAE graded low, sodium (mmol/L)- CTCAE graded high, urate (umol/L)- CTCAE graded high. CTCAE version 4.03 was used: grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening consequences; grade 0 = values not meeting any of the criteria for grade 1 or higher. |
| Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | During study treatment (maximum treatment exposure for Part I was 403.7 weeks) | Vital signs evaluated were: Low/high systolic blood pressure (BP) (millimeter of Mercury \[mmHg\]): less than or equal to (\<=) 90 mmHg with decrease from baseline of \>=20 mmHg / \>=160 mmHg with increase from baseline of \>=20 mmHg; low/high diastolic BP \[mmHg\]: \<=50 mmHg with decrease from baseline of \>=15 mmHg / \>=100 mmHg with increase from baseline of \>=15 mmHg; low/high pulse rate (beats per minute \[bpm\]): \<=50 bpm with decrease from baseline of \>=15 bpm / \>=120 bpm with increase from baseline of \>=15 bpm; low/high weight (kilogram \[kg\]): \>=20% decrease/increase from baseline; and low/high body temperature (degree Celsius \[C\]): \<=36 C / \>= 37.5 C. |
| Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | During study treatment (maximum treatment exposure for Part II was 97.0 weeks) | Vital signs evaluated were: Low/high systolic BP (mmHg): \<=90 mmHg with decrease from baseline of \>=20 mmHg / \>=160 mmHg with increase from baseline of \>=20 mmHg; low/high diastolic BP \[mmHg\]: \<=50 mmHg with decrease from baseline of \>=15 mmHg / \>=100 mmHg with increase from baseline of \>=15 mmHg; low/high pulse rate (bpm): \<=50 bpm with decrease from baseline of \>=15 bpm / \>=120 bpm with increase from baseline of \>=15 bpm; low/high weight (kg): \>=20% decrease/increase from baseline; and low/high body temperature (C): \<=36 C / \>= 37.5 C. |
| Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | During study treatment (maximum treatment exposure for Part I was 403.7 weeks) | Number of participants with notable ECG values were reported in this outcome measure. Abnormality categories were: Heart rate (HR): increase from baseline \>25% and to a value \>100 bpm, decrease from baseline \>25% and to a value \<60 bpm; PR: increase from baseline \>25% and to a value \>200 millisecond (ms); QRS: increase from baseline \>25% and to a value \>110 ms; QT: increase from baseline \>30 ms, increase from baseline \>60 ms, new interval \>450 ms, new interval \>480 ms, new interval \>500 ms; and Corrected QT interval by Fridericia (QTcF): increase from baseline \>30 ms, increase from baseline \>60 ms, new interval \>450 ms, new interval \>480 ms, new interval \>500 ms. New = newly occurred post-baseline value. |
| Number of Participants With Notable ECG Values: Part II | During study treatment (maximum treatment exposure for Part II was 97.0 weeks) | Number of participants with notable ECG values were reported in this outcome measure. Abnormality categories were: HR: increase from baseline \>25% and to a value \>100 bpm, decrease from baseline \>25% and to a value \<60 bpm; PR: increase from baseline \>25% and to a value \>200 ms; QRS: increase from baseline \>25% and to a value \>110 ms; QT: increase from baseline \>30 ms, increase from baseline \>60 ms, new interval \>450 ms, new interval \>480 ms, new interval \>500 ms; and QTcF: increase from baseline \>30 ms, increase from baseline \>60 ms, new interval \>450 ms, new interval \>480 ms, new interval \>500 ms. New = newly occurred post-baseline value. |
| Number of Participants With At Least One Dose Interruption: Part I | During study treatment (maximum treatment exposure for Part I was 403.7 weeks) | In this outcome measure number of participants with at least 1 dose interruption for encorafenib and binimetinib were reported. |
| Number of Participants With At Least One Dose Interruption: Part II | During study treatment (maximum treatment exposure for Part II was 97.0 weeks) | In this outcome measure number of participants with at least 1 dose interruption for encorafenib, binimetinib, and each third combination agent were reported. |
| Number of Participants With At Least One Dose Reduction: Part I | During study treatment (maximum treatment exposure for Part I was 403.7 weeks) | In this outcome measure number of participants with at least 1 dose reduction for encorafenib and binimetinib were reported. |
| Number of Participants With At Least One Dose Reduction: Part II | During study treatment (maximum treatment exposure for Part II was 97.0 weeks) | In this outcome measure number of participants with at least 1 dose reduction for encorafenib, binimetinib, and each third combination agent were reported. |
| Progression-Free Survival (PFS): Part I | From start of study drug until documented PD or death due to any cause or censoring date (maximum treatment exposure for Part I was 403.7 weeks) | PFS was defined as the time from the start date of study drug in Part I until documented PD or death due to any cause. All participants who had not progressed or died at the time of the data cut-off were censored at the date of last tumor assessment (other than those who were unknown or missing) prior to cut-off date or start date of new anti-neoplastic therapy, whichever is earlier. Per RECIST 1.1, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan Meier method used for estimation. |
| PFS: Part II | From start of study drug until documented PD or death due to any cause or censoring date (maximum treatment exposure for Part II was 97.0 weeks) | PFS was defined as the time from the start date of study drug in Part II until documented PD or death due to any cause. All participants who had not progressed or died at the time of the data cut-off were censored at the date of last tumor assessment (other than those who were unknown or missing) prior to cut-off date or start date of new anti-neoplastic therapy, whichever is earlier. Per RECIST 1.1, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan Meier method used for estimation. |
| Duration of Response (DOR): Part I | From date of first documented response (CR or PR) till the date of first documented progression or death due to underlying cancer or censoring date (maximum treatment exposure for Part I was 403.7 weeks) | DOR: time between date of first documented response (CR or PR) and date of first documented progression or death due to underlying cancer. If there was no progression or death due to underlying cancer, then the participant was censored at the date of last tumor assessment other than unknown. RECIST v1.1: CR = disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. All lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis); b) PR = at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters; c) PD= At least a 20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, sum must also demonstrate an absolute increase of at least 5 mm. |
| DOR: Part II | From date of first documented response (CR or PR) till the date of first documented progression or death due to underlying cancer or censoring date (maximum treatment exposure for Part II was 97.0 weeks) | DOR: time between date of first documented response (CR or PR) and date of first documented progression or death due to underlying cancer. If there was no progression or death due to underlying cancer, then the participant was censored at the date of last tumor assessment other than unknown. RECIST v1.1: CR = disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. All lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis); b) PR = at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters; c) PD= At least a 20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, sum must also demonstrate an absolute increase of at least 5 mm. |
| Time to Response (TTR): Part I | From start date of study drug till first documented response (CR or PR) (maximum treatment exposure for Part I was 403.7 weeks) | TTR was defined as the time between the start date of study drug in Part I and first documented response (CR or PR). RECIST v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis) and b) PR = at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Kaplan Meier method used for estimation. |
| TTR: Part II | From start date of study drug till first documented response (CR or PR) (maximum treatment exposure for Part II was 97.0 weeks) | TTR was defined as the time between the start date of study drug in Part II and first documented response (CR or PR). RECIST v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis) and b) PR = at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Kaplan Meier method used for estimation. |
| Disease Control Rate (DCR): Part I | From start date of study drug till first documented response (CR or PR or SD) (maximum treatment exposure for Part I was 403.7 weeks) | DCR was defined as percentage of participants with a best overall response of CR or PR or SD. RECIST v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis); b) PR = at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters and c) SD = neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| DCR: Part II | From start date of study drug till first documented response (CR or PR or SD) (maximum treatment exposure for Part II was 97.0 weeks) | DCR was defined as percentage of participants with a best overall response of CR or PR or SD. RECIST v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis); b) PR = at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters and c) SD = neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Overall Survival (OS): Part II | From date of start of treatment to date of death due to any cause or censoring date (maximum treatment exposure for Part II was 97.0 weeks) | OS was defined as the time from the start date of study treatment (3rd agent combined with encorafenib and binimetinib) to date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan Meier method used for estimation. |
| Summary of Genomic Biomarkers From Tumor Samples: Part I | Baseline up to end of treatment (EOT) (maximum treatment exposure for Part I was 403.7 weeks) | Number of participants with multiple alterations in genomic biomarkers like biomarker BRAF, CCND1, CDK4, EGFR, FGFR1, FGFR4, KRAS, MET, NRAS, PIK3CA, and PTEN were reported and alterations included copy number variant/copy number ratio (CNV/CNR), rearrangement, short variant. It was not necessary that all biomarkers had all alterations. Baseline = last non-missing value prior to the first dose of study treatment. |
| Plasma Concentration for Encorafenib (LGX): Part I | C1 (1.5 hrs post-dose on D1; pre-dose, 1.5 hrs post-dose on D15); C2 (pre-dose on D8 and D21); C3 pre-dose on D15; C4 pre-dose on D15; C5 pre-dose on D15; EOT | In results reported below, following abbreviation have been used: Cycle 1 (C1), Day 1 (D1), Day 8 (D8), Day 15 (D15), Day 21 (D21), Cycle 2 (C2), Cycle 3 (C3), Cycle 4 (C4), Cycle 5 (C5) and end of treatment (EOT). Maximum treatment exposure for Part I was of 403.7 weeks. |
| Plasma Concentration for Encorafenib (LGX): Part II | C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT | In results reported below, following abbreviation have been used: Cycle 1 (C1), Day 1 (D1), Day 8 (D8), Day 15 (D15), Day 16 (D16), Day 21 (D21), Cycle 2 (C2), Cycle 3 (C3), Cycle 4 (C4), Cycle 5 (C5). Maximum treatment exposure for Part II was of 97.0 weeks. |
| Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | C1 (1.5 hrs post-dose on D1; pre-dose, 1.5 hrs post-dose on D15); C2 (pre-dose on D8 and D21); C3 pre-dose on D15; C4 pre-dose on D15; C5 pre-dose on D15; EOT | AR00426032 is metabolite of binimetinib. Maximum treatment exposure for Part I was of 403.7 weeks. |
| Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT | AR00426032 is metabolite of binimetinib. Maximum treatment exposure for Part II was of 97.0 weeks. |
| Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT | LEQ803 is metabolite of ribociclib. Maximum treatment exposure for Part II was of 97.0 weeks. |
| Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; EOT | BHS697 and CQM157 are metabolites of infigratinib. Maximum treatment exposure for Part II was of 97.0 weeks. |
| Plasma Concentration for Capmatinib (INC): Part II | C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT | Maximum treatment exposure for Part II was of 97.0 weeks. |
| Plasma Concentration for Buparlisib (BKM): Part II | C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT | Maximum treatment exposure for Part II was of 97.0 weeks. |
| Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | C1 D15: 0.5 hour ± 10 (minutes) min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour | — |
| Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour | — |
| Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour | — |
| Actual Dose Intensity: Part I | During study treatment (maximum treatment exposure for Part I was 403.7 weeks) | Dose intensity across all cycles = cumulative dose/duration of exposure. Treatment cycle for encorafenib and binimetinib =21 days. |
| Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
| Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution is the apparent volume of distribution at steady-state. |
| Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour | — |
| Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | C1 D15: at the end of a dosing interval at steady-state (24 hour ± 2 hour), taken directly before next administration | — |
| Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour | Elimination half-life means the time required for the plasma concentration to decline by 50% during the elimination phase. |
Countries
Australia, Canada, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
This study had 2 parts. In Part I, 158 participants were enrolled and treated with encorafenib/ binimetinib (LGX818/MEK162) combination until disease progression (PD) \[as per RECISTv1.1\]. Based on the genetic assessment of a tumor biopsy obtained at PD, participants from Part I entered Part II. In Part II, 58 participants received tailored combination treatment in one of the 4 arms: encorafenib/ binimetinib + buparlisib (BKM120), infigratinib (BGJ398), capmatinib (INC280) or ribociclib (LEE011).
Participants by arm
| Arm | Count |
|---|---|
| Part I: Encorafenib + Binimetinib (Naive) Participants naive to selective V-raf murine sarcoma viral oncogene homolog B1 (BRAF) and mitogen-activated protein kinase (MEK) inhibitors, received encorafenib 450 milligram (mg) once a day and binimetinib 45 mg twice a day until disease progression or no clinical benefit. No dose reduction below 150 mg for encorafenib and 15 mg for binimetinib was permitted for this study. Treatment cycle for encorafenib and binimetinib was defined as 21 days of daily continuous treatment. | 75 |
| Part I: Encorafenib + Binimetinib (Non-naive) Participants non-naive to selective BRAF and MEK inhibitors, received encorafenib 450 mg once a day and binimetinib 45 mg twice a day until disease progression or no clinical benefit and initiation of triple combination treatment. No dose reduction below 150 mg for encorafenib and 15 mg for binimetinib was permitted for this study. Treatment cycle for both drugs was defined as 21 days of daily continuous treatment. | 83 |
| Part II: Encorafenib + Binimetinib + Ribociclib Participants, received encorafenib 200 mg (starting dose) once a day, binimetinib 45 mg (starting dose) twice a day and ribociclib 100 mg (starting dose) once a day until disease progression or no clinical benefit. No dose reduction below 50 mg for encorafenib and 15 mg for binimetinib was permitted for this study. For ribociclib dose escalation was allowed till 600 mg and dose reduction was permitted till 50 mg. Ribociclib was taken for 21 consecutive days followed by a 7-day planned break. Treatment cycle =28 days. | 38 |
| Part II: Encorafenib + Binimetinib + Infigratinib Participants, received encorafenib 450 mg (starting dose) once a day, binimetinib 45 mg (starting dose) twice a day and infigratinib 75 mg (starting dose) once a day until disease progression or no clinical benefit. No dose reduction below 150 mg for encorafenib and 15 mg for binimetinib was permitted for this study. For infigratinib dose escalation was allowed till 125 mg and dose reduction was permitted till 25 mg. Infigratinib was taken for 21 consecutive days followed by a 7-day planned break. Treatment cycle =28 days. | 1 |
| Part II: Encorafenib + Binimetinib + Capmatinib Participants, received encorafenib 200 mg (starting dose) once a day, binimetinib 45 mg (starting dose) twice a day and capmatinib 200 mg (starting dose) capsule or 400 mg (starting dose) tablet twice a day until disease progression or no clinical benefit. No dose reduction below 50 mg for encorafenib and 15 mg for binimetinib was permitted for this study. For capmatinib dose escalation was allowed till 600 mg and dose reduction was permitted till 50 mg. Treatment cycle for encorafenib, binimetinib and capmatinib was defined as 21 days of daily continuous treatment. | 13 |
| Part II: Encorafenib + Binimetinib + Buparlisib Participants, received encorafenib 450 mg (starting dose) once a day, binimetinib 45 mg (starting dose) twice a day and buparlisib 60 mg (starting dose) once a day until disease progression or no clinical benefit. No dose reduction below 150 mg for encorafenib and 15 mg for binimetinib was permitted for this study. For buparlisib dose escalation was allowed till 100 mg and dose reduction was permitted till 30 mg. Treatment cycle for encorafenib, binimetinib and buparlisib was defined as 21 days of daily continuous treatment. | 6 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Part I | Adverse Event | 7 | 5 | 0 | 0 | 0 | 0 |
| Part I | Death | 11 | 9 | 0 | 0 | 0 | 0 |
| Part I | Missing Data | 1 | 0 | 0 | 0 | 0 | 0 |
| Part I | New Therapy for Study Indication | 5 | 4 | 0 | 0 | 0 | 0 |
| Part I | Participant/Guardian Decision | 9 | 3 | 0 | 0 | 0 | 0 |
| Part I | Physician Decision | 2 | 9 | 0 | 0 | 0 | 0 |
| Part I | Progressive Disease | 37 | 46 | 0 | 0 | 0 | 0 |
| Part I | Termination of participants from the study | 3 | 3 | 0 | 0 | 0 | 0 |
| Part II | Adverse Event | 0 | 0 | 1 | 0 | 1 | 1 |
| Part II | Death | 0 | 0 | 1 | 0 | 2 | 1 |
| Part II | New Therapy for Study Indication | 0 | 0 | 0 | 0 | 1 | 0 |
| Part II | Participant/Guardian Decision | 0 | 0 | 0 | 0 | 2 | 0 |
| Part II | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 |
| Part II | Progressive Disease | 0 | 0 | 35 | 1 | 7 | 4 |
Baseline characteristics
| Characteristic | Part I: Encorafenib + Binimetinib (Naive) | Part I: Encorafenib + Binimetinib (Non-naive) | Part II: Encorafenib + Binimetinib + Ribociclib | Part II: Encorafenib + Binimetinib + Infigratinib | Part II: Encorafenib + Binimetinib + Capmatinib | Part II: Encorafenib + Binimetinib + Buparlisib | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized Part I 18-44 years | 14 Participants | 24 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 38 Participants |
| Age, Customized Part I 45-64 years | 43 Participants | 37 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 80 Participants |
| Age, Customized Part I 65 years and over | 18 Participants | 22 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 40 Participants |
| Age, Customized Part I Not disclosed | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Part II 18-44 years | 0 Participants | 0 Participants | 9 Participants | 0 Participants | 0 Participants | 1 Participants | 10 Participants |
| Age, Customized Part II 45-64 years | 0 Participants | 0 Participants | 19 Participants | 0 Participants | 7 Participants | 4 Participants | 30 Participants |
| Age, Customized Part II 65 years and over | 0 Participants | 0 Participants | 10 Participants | 0 Participants | 6 Participants | 1 Participants | 17 Participants |
| Age, Customized Part II Not disclosed | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity: Part I Hispanic or Latino | 3 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Ethnicity: Part I Not Disclosed | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity: Part I Not Hispanic or Latino | 72 Participants | 76 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 148 Participants |
| Race/Ethnicity, Customized Ethnicity: Part II Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity: Part II Not Disclosed | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity: Part II Not Hispanic or Latino | 0 Participants | 0 Participants | 37 Participants | 0 Participants | 13 Participants | 6 Participants | 56 Participants |
| Race/Ethnicity, Customized Race: Part I Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race: Part I Caucasian | 74 Participants | 82 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 156 Participants |
| Race/Ethnicity, Customized Race: Part I Not Disclosed | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race: Part II Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race: Part II Caucasian | 0 Participants | 0 Participants | 37 Participants | 0 Participants | 13 Participants | 6 Participants | 56 Participants |
| Race/Ethnicity, Customized Race: Part II Not Disclosed | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Part I Female | 28 Participants | 39 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 67 Participants |
| Sex/Gender, Customized Part I Male | 47 Participants | 44 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 91 Participants |
| Sex/Gender, Customized Part I Not Disclosed | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Part II Female | 0 Participants | 0 Participants | 22 Participants | 0 Participants | 5 Participants | 1 Participants | 28 Participants |
| Sex/Gender, Customized Part II Male | 0 Participants | 0 Participants | 16 Participants | 0 Participants | 8 Participants | 5 Participants | 29 Participants |
| Sex/Gender, Customized Part II Not Disclosed | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 20 / 75 | 29 / 83 | 28 / 38 | 1 / 1 | 8 / 13 | 4 / 6 |
| other Total, other adverse events | 75 / 75 | 73 / 83 | 33 / 38 | 0 / 1 | 11 / 13 | 5 / 6 |
| serious Total, serious adverse events | 47 / 75 | 37 / 83 | 19 / 38 | 0 / 1 | 6 / 13 | 4 / 6 |
Outcome results
Overall Response Rate (ORR): Part II
ORR: percentage of participants with confirmed complete response (CR) and partial response (PR). Response evaluation criteria in solid tumors (RECIST) v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions that had a reduction in short axis to less than (\<) 10 millimeter (mm). Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis) and b) PR = at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Any radiological assessments taken more than 30 days after the last dose of study therapy or after antineoplastic agents other than study treatments taken by the participants was excluded from the best overall response derivation. Confirmation of CR or PR was to be at least 4 weeks apart from the previous radiological assessment.
Time frame: From the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (maximum treatment exposure for Part II was 97.0 weeks)
Population: For Part II, full analysis set (FAS) consisted of all participants who received at least 1 dose of encorafenib or binimetinib or the assigned third agent following the assignment of the triple combination treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Overall Response Rate (ORR): Part II | 2.6 Percentage of participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Overall Response Rate (ORR): Part II | 0 Percentage of participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Overall Response Rate (ORR): Part II | 0 Percentage of participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Overall Response Rate (ORR): Part II | 0 Percentage of participants |
Actual Dose Intensity: Part I
Dose intensity across all cycles = cumulative dose/duration of exposure. Treatment cycle for encorafenib and binimetinib =21 days.
Time frame: During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Population: Safety set included all participants who received at least 1 dose of encorafenib or binimetinib for Part I and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Actual Dose Intensity: Part I | Encorafenib | 425.311 Milligram per day | Standard Deviation 53.5392 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Actual Dose Intensity: Part I | Binimetinib | 81.920 Milligram per day | Standard Deviation 13.0994 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Actual Dose Intensity: Part I | Encorafenib | 408.711 Milligram per day | Standard Deviation 65.5297 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Actual Dose Intensity: Part I | Binimetinib | 82.083 Milligram per day | Standard Deviation 10.9117 |
Actual Dose Intensity: Part II
Dose intensity = cumulative dose/ duration of exposure. Treatment cycle = 21days for the combination treatment with buparlisib and capmatinib and 28 days for the combination treatment with ribociclib and infigratinib.
Time frame: During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Population: Safety set included all participants who received at least 1 dose of 3rd combination agent for Part II and had at least 1 valid post-baseline safety assessment. Here, Number Analyzed signifies number of participants evaluable for specified drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Actual Dose Intensity: Part II | Encorafenib | 197.856 Milligram per day | Standard Deviation 42.6637 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Actual Dose Intensity: Part II | Ribociclib | 486.628 Milligram per day | Standard Deviation 79.4485 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Actual Dose Intensity: Part II | Binimetinib | 79.749 Milligram per day | Standard Deviation 14.7267 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Actual Dose Intensity: Part II | Encorafenib | 450.000 Milligram per day | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Actual Dose Intensity: Part II | Infigratinib | 60.227 Milligram per day | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Actual Dose Intensity: Part II | Binimetinib | 90.000 Milligram per day | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Actual Dose Intensity: Part II | Binimetinib | 87.373 Milligram per day | Standard Deviation 3.6593 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Actual Dose Intensity: Part II | Encorafenib | 195.945 Milligram per day | Standard Deviation 8.4015 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Actual Dose Intensity: Part II | Capmatinib | 579.519 Milligram per day | Standard Deviation 259.1157 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Actual Dose Intensity: Part II | Encorafenib | 405.014 Milligram per day | Standard Deviation 102.5218 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Actual Dose Intensity: Part II | Buparlisib | 72.206 Milligram per day | Standard Deviation 15.7019 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Actual Dose Intensity: Part II | Binimetinib | 78.791 Milligram per day | Standard Deviation 20.1538 |
Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time frame: C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified study treatment for respective arms.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Buparlisib | 28.2 Liter per hour | Geometric Coefficient of Variation 53.6 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 28.5 Liter per hour | Geometric Coefficient of Variation 14.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 49.6 Liter per hour | Geometric Coefficient of Variation 42.1 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Buparlisib | 23.2 Liter per hour | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 44.7 Liter per hour | Geometric Coefficient of Variation 18.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 36.9 Liter per hour | Geometric Coefficient of Variation 105.7 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 35.6 Liter per hour | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 60.7 Liter per hour | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Capmatinib | 65.9 Liter per hour | Geometric Coefficient of Variation 52.2 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 20.8 Liter per hour | Geometric Coefficient of Variation 28.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 40.1 Liter per hour | Geometric Coefficient of Variation 42.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 18.6 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Capmatinib | 24.8 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 15.1 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 16.3 Liter per hour | Geometric Coefficient of Variation 5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Capmatinib | 45.7 Liter per hour | Geometric Coefficient of Variation 24.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 23.4 Liter per hour | Geometric Coefficient of Variation 10.7 |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 28.7 Liter per hour | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 17.4 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 243 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 33.3 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 15.8 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 26.5 Liter per hour | Geometric Coefficient of Variation 22.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 161 Liter per hour | Geometric Coefficient of Variation 61.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 34.9 Liter per hour | Geometric Coefficient of Variation 6.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 173 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 32.2 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 25.9 Liter per hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 19.5 Liter per hour | Geometric Coefficient of Variation 44.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 19.9 Liter per hour | Geometric Coefficient of Variation 29.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 62.4 Liter per hour | Geometric Coefficient of Variation 58.5 |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 99.3 Liter per hour | — |
Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution is the apparent volume of distribution at steady-state.
Time frame: C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified study treatment for respective arms.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 268 Liter | Geometric Coefficient of Variation 45.4 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 324 Liter | Geometric Coefficient of Variation 58.3 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Buparlisib | 604 Liter | Geometric Coefficient of Variation 17.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 185 Liter | Geometric Coefficient of Variation 83.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 324 Liter | Geometric Coefficient of Variation 69.8 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 313 Liter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 82.5 Liter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 226 Liter | Geometric Coefficient of Variation 92.9 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 244 Liter | Geometric Coefficient of Variation 75.9 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Capmatinib | 190 Liter | Geometric Coefficient of Variation 30.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Capmatinib | 89.5 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 91.7 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Capmatinib | 233 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 133 Liter | Geometric Coefficient of Variation 13.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 125 Liter | Geometric Coefficient of Variation 56.1 |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 147 Liter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 177 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 180 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 86.8 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 3160 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 184 Liter | Geometric Coefficient of Variation 111.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 210 Liter | Geometric Coefficient of Variation 32.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 1930 Liter | Geometric Coefficient of Variation 30.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 2660 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 406 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 178 Liter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Binimetinib | 113 Liter | Geometric Coefficient of Variation 48.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Encorafenib | 99.3 Liter | Geometric Coefficient of Variation 46 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 677 Liter | Geometric Coefficient of Variation 65 |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II | Ribociclib | 1440 Liter | — |
Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II
Time frame: C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified study treatment or metabolites for respective arms.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 9080 Hour*nanogram per milliliter | Geometric Coefficient of Variation 42.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Buparlisib | 2130 Hour*nanogram per milliliter | Geometric Coefficient of Variation 54.6 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1580 Hour*nanogram per milliliter | Geometric Coefficient of Variation 17 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 116 Hour*nanogram per milliliter | Geometric Coefficient of Variation 66.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Buparlisib | 3400 Hour*nanogram per milliliter | Geometric Coefficient of Variation 18.5 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1220 Hour*nanogram per milliliter | Geometric Coefficient of Variation 105.7 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 10100 Hour*nanogram per milliliter | Geometric Coefficient of Variation 18.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 94.4 Hour*nanogram per milliliter | Geometric Coefficient of Variation 222.2 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 42.0 Hour*nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 7420 Hour*nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1260 Hour*nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 2180 Hour*nanogram per milliliter | Geometric Coefficient of Variation 29.4 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 4990 Hour*nanogram per milliliter | Geometric Coefficient of Variation 42.6 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 124 Hour*nanogram per milliliter | Geometric Coefficient of Variation 113.9 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Capmatinib | 3070 Hour*nanogram per milliliter | Geometric Coefficient of Variation 52.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Capmatinib | 12200 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 3040 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 135 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 10800 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 2760 Hour*nanogram per milliliter | Geometric Coefficient of Variation 4.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 8570 Hour*nanogram per milliliter | Geometric Coefficient of Variation 10.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Capmatinib | 8420 Hour*nanogram per milliliter | Geometric Coefficient of Variation 22 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 182 Hour*nanogram per milliliter | Geometric Coefficient of Variation 43.1 |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 3490 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 5630 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 81.5 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1700 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 2770 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1900 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 1640 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 6000 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 1650 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 47.0 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 3730 Hour*nanogram per milliliter | Geometric Coefficient of Variation 62.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 1900 Hour*nanogram per milliliter | Geometric Coefficient of Variation 24.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 5740 Hour*nanogram per milliliter | Geometric Coefficient of Variation 7.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1140 Hour*nanogram per milliliter | Geometric Coefficient of Variation 21.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 57.9 Hour*nanogram per milliliter | Geometric Coefficient of Variation 128.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 66.9 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 6200 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1740 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 2320 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 930 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 115 Hour*nanogram per milliliter | Geometric Coefficient of Variation 92.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 11300 Hour*nanogram per milliliter | Geometric Coefficient of Variation 41.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 2270 Hour*nanogram per milliliter | Geometric Coefficient of Variation 29.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 9230 Hour*nanogram per milliliter | Geometric Coefficient of Variation 60.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 2540 Hour*nanogram per milliliter | Geometric Coefficient of Variation 31.3 |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 5960 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 2300 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 41.1 Hour*nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1470 Hour*nanogram per milliliter | — |
DCR: Part II
DCR was defined as percentage of participants with a best overall response of CR or PR or SD. RECIST v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis); b) PR = at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters and c) SD = neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From start date of study drug till first documented response (CR or PR or SD) (maximum treatment exposure for Part II was 97.0 weeks)
Population: For Part II, FAS consisted of all participants who received at least 1 dose of encorafenib or binimetinib or the assigned third agent following the assignment of the triple combination treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | DCR: Part II | 26.3 Percentage of participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | DCR: Part II | 0 Percentage of participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | DCR: Part II | 15.4 Percentage of participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | DCR: Part II | 16.7 Percentage of participants |
Disease Control Rate (DCR): Part I
DCR was defined as percentage of participants with a best overall response of CR or PR or SD. RECIST v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis); b) PR = at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters and c) SD = neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From start date of study drug till first documented response (CR or PR or SD) (maximum treatment exposure for Part I was 403.7 weeks)
Population: For Part I, FAS consisted of all participants who received at least 1 dose (partial or full) of encorafenib or binimetinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Disease Control Rate (DCR): Part I | 92.0 Percentage of participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Disease Control Rate (DCR): Part I | 42.2 Percentage of participants |
DOR: Part II
DOR: time between date of first documented response (CR or PR) and date of first documented progression or death due to underlying cancer. If there was no progression or death due to underlying cancer, then the participant was censored at the date of last tumor assessment other than unknown. RECIST v1.1: CR = disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. All lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis); b) PR = at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters; c) PD= At least a 20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From date of first documented response (CR or PR) till the date of first documented progression or death due to underlying cancer or censoring date (maximum treatment exposure for Part II was 97.0 weeks)
Population: For Part II, FAS consisted of all participants who received at least 1 dose of encorafenib or binimetinib or the assigned third agent following the assignment of the triple combination treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure who were confirmed responders. Kaplan Meier method used for estimation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | DOR: Part II | 2.1 Months |
Duration of Response (DOR): Part I
DOR: time between date of first documented response (CR or PR) and date of first documented progression or death due to underlying cancer. If there was no progression or death due to underlying cancer, then the participant was censored at the date of last tumor assessment other than unknown. RECIST v1.1: CR = disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. All lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis); b) PR = at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters; c) PD= At least a 20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From date of first documented response (CR or PR) till the date of first documented progression or death due to underlying cancer or censoring date (maximum treatment exposure for Part I was 403.7 weeks)
Population: For Part I, FAS consisted of all participants who received at least 1 dose (partial or full) of encorafenib or binimetinib. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure who were confirmed responders. Kaplan Meier method used for estimation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Duration of Response (DOR): Part I | 10.9 Months |
| Part II: Encorafenib + Binimetinib + Infigratinib | Duration of Response (DOR): Part I | 5.6 Months |
Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II
Elimination half-life means the time required for the plasma concentration to decline by 50% during the elimination phase.
Time frame: C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified study treatment or metabolites for respective arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 6.35 Hour | Standard Deviation 1.21 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 3.75 Hour | Standard Deviation 0.302 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Buparlisib | 15.4 Hour | Standard Deviation 4.62 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 8.35 Hour | Standard Deviation 3.52 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 4.14 Hour | Standard Deviation 0.683 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 3.48 Hour | Standard Deviation 0.484 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 5.89 Hour | Standard Deviation 4.32 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.59 Hour | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 3.57 Hour | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.60 Hour | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 4.18 Hour | Standard Deviation 1.85 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Capmatinib | 2.18 Hour | Standard Deviation 0.0599 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 7.95 Hour | Standard Deviation 4.03 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 10.3 Hour | Standard Deviation 6.29 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 2.86 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Capmatinib | 2.50 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 3.41 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 3.96 Hour | Standard Deviation 0.233 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 5.88 Hour | Standard Deviation 2.77 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 5.64 Hour | Standard Deviation 2.49 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Capmatinib | 2.82 Hour | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 4.27 Hour | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 5.84 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 19.9 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 3.82 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 4.34 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 3.75 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 9.01 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 5.38 Hour | Standard Deviation 3.39 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 6.24 Hour | Standard Deviation 4.43 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 4.32 Hour | Standard Deviation 1.62 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 8.44 Hour | Standard Deviation 2.21 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 14.1 Hour | Standard Deviation 4.04 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 10.7 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 3.83 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 19.2 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 10.9 Hour | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib | 4.13 Hour | Standard Deviation 1.42 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 16.0 Hour | Standard Deviation 4.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 5.91 Hour | Standard Deviation 3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Encorafenib | 3.60 Hour | Standard Deviation 0.711 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 7.77 Hour | Standard Deviation 1.95 |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II | Ribociclib | 10.1 Hour | — |
Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II
Time frame: C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified study treatment or metabolites for respective arms.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 3.99 Nanogram per milliliter | Geometric Coefficient of Variation 61.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 44.1 Nanogram per milliliter | Geometric Coefficient of Variation 19.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Buparlisib | 41.8 Nanogram per milliliter | Geometric Coefficient of Variation 82.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 11.3 Nanogram per milliliter | Geometric Coefficient of Variation 45.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 2.92 Nanogram per milliliter | Geometric Coefficient of Variation 159.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 30.2 Nanogram per milliliter | Geometric Coefficient of Variation 59.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 25.1 Nanogram per milliliter | Geometric Coefficient of Variation 2066.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Buparlisib | 101 Nanogram per milliliter | Geometric Coefficient of Variation 1.4 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib metabolite, BHS697 | 5.57 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 6.76 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 55.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.82 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib | 20.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib metabolite, CQM157 | 32.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 5.57 Nanogram per milliliter | Geometric Coefficient of Variation 130.2 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 79.6 Nanogram per milliliter | Geometric Coefficient of Variation 103.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 15.9 Nanogram per milliliter | Geometric Coefficient of Variation 315.9 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 63.2 Nanogram per milliliter | Geometric Coefficient of Variation 64 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 17.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 5.20 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.44 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 58.1 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 55.9 Nanogram per milliliter | Geometric Coefficient of Variation 54 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 4.75 Nanogram per milliliter | Geometric Coefficient of Variation 25.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 269 Nanogram per milliliter | Geometric Coefficient of Variation 68.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 15.0 Nanogram per milliliter | Geometric Coefficient of Variation 20.9 |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 10.7 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 78.3 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 6.53 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 94.0 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 84.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 25.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 7.85 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 29.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 46.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.08 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 42.5 Nanogram per milliliter | Geometric Coefficient of Variation 13.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 10.8 Nanogram per milliliter | Geometric Coefficient of Variation 106.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 52.7 Nanogram per milliliter | Geometric Coefficient of Variation 90.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 2.31 Nanogram per milliliter | Geometric Coefficient of Variation 47.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 23.1 Nanogram per milliliter | Geometric Coefficient of Variation 5.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 47.9 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 34.9 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 10.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 22.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 3.54 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 58.7 Nanogram per milliliter | Geometric Coefficient of Variation 60.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 73.2 Nanogram per milliliter | Geometric Coefficient of Variation 49.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 33.7 Nanogram per milliliter | Geometric Coefficient of Variation 254.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 4.68 Nanogram per milliliter | Geometric Coefficient of Variation 92.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 147 Nanogram per milliliter | Geometric Coefficient of Variation 71.8 |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 91.8 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 40.5 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 59.6 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.56 Nanogram per milliliter | — |
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II
Time frame: C1 D15: 0.5 hour ± 10 (minutes) min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified study treatment or metabolites for respective arms.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Buparlisib | 266 Nanogram per milliliter | Geometric Coefficient of Variation 51.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 386 Nanogram per milliliter | Geometric Coefficient of Variation 41.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 3060 Nanogram per milliliter | Geometric Coefficient of Variation 58.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 24.9 Nanogram per milliliter | Geometric Coefficient of Variation 92.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 2150 Nanogram per milliliter | Geometric Coefficient of Variation 54.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 221 Nanogram per milliliter | Geometric Coefficient of Variation 237.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Buparlisib | 312 Nanogram per milliliter | Geometric Coefficient of Variation 10.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 18.1 Nanogram per milliliter | Geometric Coefficient of Variation 591.2 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 15.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 413 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 2100 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib metabolite, BHS697 | 8.53 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib metabolite, CQM157 | 32.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib | 27.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 722 Nanogram per milliliter | Geometric Coefficient of Variation 85.3 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1600 Nanogram per milliliter | Geometric Coefficient of Variation 62 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 515 Nanogram per milliliter | Geometric Coefficient of Variation 17 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 27.9 Nanogram per milliliter | Geometric Coefficient of Variation 85.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 2890 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 3670 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 22.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 797 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 47.1 Nanogram per milliliter | Geometric Coefficient of Variation 29.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 2570 Nanogram per milliliter | Geometric Coefficient of Variation 23 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 1920 Nanogram per milliliter | Geometric Coefficient of Variation 31.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 858 Nanogram per milliliter | Geometric Coefficient of Variation 13 |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 261 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 622 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 434 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 175 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 12.9 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 93.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1960 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 520 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 12.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 126 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 313 Nanogram per milliliter | Geometric Coefficient of Variation 15.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1860 Nanogram per milliliter | Geometric Coefficient of Variation 32.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 16.1 Nanogram per milliliter | Geometric Coefficient of Variation 151.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 428 Nanogram per milliliter | Geometric Coefficient of Variation 84.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 144 Nanogram per milliliter | Geometric Coefficient of Variation 19.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 19.4 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 584 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 282 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 2010 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 67.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 23.7 Nanogram per milliliter | Geometric Coefficient of Variation 94.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 753 Nanogram per milliliter | Geometric Coefficient of Variation 70.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 156 Nanogram per milliliter | Geometric Coefficient of Variation 36.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 489 Nanogram per milliliter | Geometric Coefficient of Variation 31.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 2030 Nanogram per milliliter | Geometric Coefficient of Variation 40.6 |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 9.04 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 138 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 597 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 291 Nanogram per milliliter | — |
Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II
Time frame: C1 D15: at the end of a dosing interval at steady-state (24 hour ± 2 hour), taken directly before next administration
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified study treatment or metabolites for respective arms.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 3.14 Nanogram per milliliter | Geometric Coefficient of Variation 74.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 32.0 Nanogram per milliliter | Geometric Coefficient of Variation 17.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Buparlisib | 49.7 Nanogram per milliliter | Geometric Coefficient of Variation 115.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 11.2 Nanogram per milliliter | Geometric Coefficient of Variation 106.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 3.80 Nanogram per milliliter | Geometric Coefficient of Variation 111.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 39.1 Nanogram per milliliter | Geometric Coefficient of Variation 57.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 18.6 Nanogram per milliliter | Geometric Coefficient of Variation 159.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Buparlisib | 97.3 Nanogram per milliliter | Geometric Coefficient of Variation 16.2 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib metabolite, BHS697 | 1.64 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 7.74 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 33.9 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.21 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib | 2.49 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib metabolite, CQM157 | 11.1 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 8.22 Nanogram per milliliter | Geometric Coefficient of Variation 84.6 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 83.9 Nanogram per milliliter | Geometric Coefficient of Variation 34 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 11.6 Nanogram per milliliter | Geometric Coefficient of Variation 51.3 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 81.2 Nanogram per milliliter | Geometric Coefficient of Variation 47.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 47.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 7.95 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 4.36 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 71.4 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 50.9 Nanogram per milliliter | Geometric Coefficient of Variation 34.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 5.45 Nanogram per milliliter | Geometric Coefficient of Variation 42.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 173 Nanogram per milliliter | Geometric Coefficient of Variation 41.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 13.5 Nanogram per milliliter | Geometric Coefficient of Variation 35 |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 9.28 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 54.3 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 4.16 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 98.4 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 76.0 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 28.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 10.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 28.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 37.1 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 32.9 Nanogram per milliliter | Geometric Coefficient of Variation 25.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 7.75 Nanogram per milliliter | Geometric Coefficient of Variation 37.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 30.7 Nanogram per milliliter | Geometric Coefficient of Variation 24.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 3.81 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 21.1 Nanogram per milliliter | Geometric Coefficient of Variation 23.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 31.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 36.4 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 10.4 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 22.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.72 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 51.0 Nanogram per milliliter | Geometric Coefficient of Variation 76.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 55.1 Nanogram per milliliter | Geometric Coefficient of Variation 33.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 21.7 Nanogram per milliliter | Geometric Coefficient of Variation 185.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 4.34 Nanogram per milliliter | Geometric Coefficient of Variation 79.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 104 Nanogram per milliliter | Geometric Coefficient of Variation 54.2 |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 64.7 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 36.2 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 49.2 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.09 Nanogram per milliliter | — |
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Part I
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after participants' signed informed consent has been obtained. An SAE was an AE resulting in any of the following outcomes: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. AEs included both SAEs and all Non-SAEs.
Time frame: Day 1 up to 30 days after last dose (maximum treatment exposure for Part I was 403.7 weeks)
Population: Safety set included all participants who received at least 1 dose of encorafenib or binimetinib for Part I and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Part I | AEs | 75 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Part I | SAEs | 47 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Part I | AEs | 78 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Part I | SAEs | 37 Participants |
Number of Participants With AEs and SAEs: Part II
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after participants' signed informed consent has been obtained. An SAE was an AE resulting in any of the following outcomes: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. AEs included both SAEs and all Non-SAEs.
Time frame: Day 1 up to 30 days after last dose (maximum treatment exposure for Part II was 97.0 weeks)
Population: Safety set included all participants who received at least 1 dose of 3rd combination agent for Part II and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With AEs and SAEs: Part II | AEs | 37 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With AEs and SAEs: Part II | SAEs | 19 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With AEs and SAEs: Part II | SAEs | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With AEs and SAEs: Part II | AEs | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With AEs and SAEs: Part II | AEs | 12 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With AEs and SAEs: Part II | SAEs | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With AEs and SAEs: Part II | AEs | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With AEs and SAEs: Part II | SAEs | 4 Participants |
Number of Participants With At Least One Dose Interruption: Part I
In this outcome measure number of participants with at least 1 dose interruption for encorafenib and binimetinib were reported.
Time frame: During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Population: Safety set included all participants who received at least 1 dose of encorafenib or binimetinib for Part I and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Interruption: Part I | Encorafenib | 46 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Interruption: Part I | Binimetinib | 44 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Interruption: Part I | Encorafenib | 40 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Interruption: Part I | Binimetinib | 41 Participants |
Number of Participants With At Least One Dose Interruption: Part II
In this outcome measure number of participants with at least 1 dose interruption for encorafenib, binimetinib, and each third combination agent were reported.
Time frame: During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Population: Safety set included all participants who received at least 1 dose of 3rd combination agent for Part II and had at least 1 valid post-baseline safety assessment. Here, Number Analyzed signifies number of participants evaluable for specified treatment in the respective reporting arms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Interruption: Part II | Encorafenib | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Interruption: Part II | Ribociclib | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Interruption: Part II | Binimetinib | 13 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Interruption: Part II | Encorafenib | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Interruption: Part II | Infigratinib | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Interruption: Part II | Binimetinib | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With At Least One Dose Interruption: Part II | Binimetinib | 5 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With At Least One Dose Interruption: Part II | Encorafenib | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With At Least One Dose Interruption: Part II | Capmatinib | 5 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With At Least One Dose Interruption: Part II | Encorafenib | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With At Least One Dose Interruption: Part II | Buparlisib | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With At Least One Dose Interruption: Part II | Binimetinib | 3 Participants |
Number of Participants With At Least One Dose Reduction: Part I
In this outcome measure number of participants with at least 1 dose reduction for encorafenib and binimetinib were reported.
Time frame: During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Population: Safety set included all participants who received at least 1 dose of encorafenib or binimetinib for Part I and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Reduction: Part I | Encorafenib | 9 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Reduction: Part I | Binimetinib | 32 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Reduction: Part I | Encorafenib | 14 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Reduction: Part I | Binimetinib | 28 Participants |
Number of Participants With At Least One Dose Reduction: Part II
In this outcome measure number of participants with at least 1 dose reduction for encorafenib, binimetinib, and each third combination agent were reported.
Time frame: During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Population: Safety set included all participants who received at least 1 dose of 3rd combination agent for Part II and had at least 1 valid post-baseline safety assessment. Here, Number Analyzed signifies number of participants evaluable for specified treatment in the respective reporting arms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Reduction: Part II | Encorafenib | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Reduction: Part II | Ribociclib | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With At Least One Dose Reduction: Part II | Binimetinib | 11 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Reduction: Part II | Encorafenib | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Reduction: Part II | Infigratinib | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With At Least One Dose Reduction: Part II | Binimetinib | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With At Least One Dose Reduction: Part II | Binimetinib | 5 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With At Least One Dose Reduction: Part II | Encorafenib | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With At Least One Dose Reduction: Part II | Capmatinib | 7 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With At Least One Dose Reduction: Part II | Encorafenib | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With At Least One Dose Reduction: Part II | Buparlisib | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With At Least One Dose Reduction: Part II | Binimetinib | 3 Participants |
Number of Participants With Dose Limiting Toxicities (DLTs) in Cycle 1: Part II
DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (first 21 days for infigratinib and capmatinib; 28 days for ribociclib and buparlisib) of treatment initiation and met the defined criteria for study.
Time frame: Cycle 1 (21 days following the first dose of the combination treatment with buparlisib and capmatinib; 28 days for the combination with ribociclib and infigratinib)
Population: Dose-determining analysis set (DDS) consisted of all participants from the safety set for Part II who met the minimum requirements for safety evaluation and minimum exposure or experienced DLT during the first cycle of the assigned triple combination treatment. No participants were included in the dose-determining analysis set in the encorafenib/binimetinib+ infigratinib or buparlisib arm, hence no participants analyzed for these reporting arms for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Dose Limiting Toxicities (DLTs) in Cycle 1: Part II | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Dose Limiting Toxicities (DLTs) in Cycle 1: Part II | 0 Participants |
Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I
Vital signs evaluated were: Low/high systolic blood pressure (BP) (millimeter of Mercury \[mmHg\]): less than or equal to (\<=) 90 mmHg with decrease from baseline of \>=20 mmHg / \>=160 mmHg with increase from baseline of \>=20 mmHg; low/high diastolic BP \[mmHg\]: \<=50 mmHg with decrease from baseline of \>=15 mmHg / \>=100 mmHg with increase from baseline of \>=15 mmHg; low/high pulse rate (beats per minute \[bpm\]): \<=50 bpm with decrease from baseline of \>=15 bpm / \>=120 bpm with increase from baseline of \>=15 bpm; low/high weight (kilogram \[kg\]): \>=20% decrease/increase from baseline; and low/high body temperature (degree Celsius \[C\]): \<=36 C / \>= 37.5 C.
Time frame: During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Population: Safety set included all participants who received at least 1 dose of encorafenib or binimetinib for Part I and had at least 1 valid post-baseline safety assessment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Pulse Rate: High | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Pulse Rate: Low | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Systolic BP: High | 18 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Systolic BP: Low | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Diastolic BP: High | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Diastolic BP: Low | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Weight: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Weight: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Body temperature: High | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Body temperature: Low | 44 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Weight: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Pulse Rate: High | 8 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Diastolic BP: Low | 3 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Pulse Rate: Low | 4 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Body temperature: Low | 36 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Systolic BP: High | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Weight: High | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Systolic BP: Low | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Body temperature: High | 14 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I | Sitting Diastolic BP: High | 4 Participants |
Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II
Vital signs evaluated were: Low/high systolic BP (mmHg): \<=90 mmHg with decrease from baseline of \>=20 mmHg / \>=160 mmHg with increase from baseline of \>=20 mmHg; low/high diastolic BP \[mmHg\]: \<=50 mmHg with decrease from baseline of \>=15 mmHg / \>=100 mmHg with increase from baseline of \>=15 mmHg; low/high pulse rate (bpm): \<=50 bpm with decrease from baseline of \>=15 bpm / \>=120 bpm with increase from baseline of \>=15 bpm; low/high weight (kg): \>=20% decrease/increase from baseline; and low/high body temperature (C): \<=36 C / \>= 37.5 C.
Time frame: During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Population: Safety set included all participants who received at least 1 dose of 3rd combination agent for Part II and had at least 1 valid post-baseline safety assessment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Weight: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Diastolic BP: Low | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Diastolic BP: High | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Pulse Rate: High | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Body temperature: Low | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Systolic BP: High | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Body temperature: High | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Systolic BP: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Weight: Low | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Pulse Rate: Low | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Weight: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Diastolic BP: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Pulse Rate: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Weight: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Systolic BP: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Body temperature: Low | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Body temperature: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Pulse Rate: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Diastolic BP: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Systolic BP: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Weight: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Pulse Rate: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Systolic BP: High | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Systolic BP: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Pulse Rate: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Diastolic BP: High | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Diastolic BP: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Weight: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Body temperature: High | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Body temperature: Low | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Pulse Rate: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Weight: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Pulse Rate: High | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Systolic BP: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Body temperature: Low | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Body temperature: High | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Systolic BP: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Weight: High | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Diastolic BP: Low | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II | Sitting Diastolic BP: High | 0 Participants |
Number of Participants With Notable ECG Values: Part II
Number of participants with notable ECG values were reported in this outcome measure. Abnormality categories were: HR: increase from baseline \>25% and to a value \>100 bpm, decrease from baseline \>25% and to a value \<60 bpm; PR: increase from baseline \>25% and to a value \>200 ms; QRS: increase from baseline \>25% and to a value \>110 ms; QT: increase from baseline \>30 ms, increase from baseline \>60 ms, new interval \>450 ms, new interval \>480 ms, new interval \>500 ms; and QTcF: increase from baseline \>30 ms, increase from baseline \>60 ms, new interval \>450 ms, new interval \>480 ms, new interval \>500 ms. New = newly occurred post-baseline value.
Time frame: During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Population: Safety set included all participants who received at least 1 dose of 3rd combination agent for Part II and had at least 1 valid post-baseline safety assessment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >480 ms | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >450 ms | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QT: Increase from baseline >30 ms | 24 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | HR: Increase from baseline >25% & to a value >100 bpm | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QT: Increase from baseline >60 ms | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >450 ms | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QTcF: Increase from baseline >60 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | PR: Increase from baseline >25% & to a value >200 ms | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >480 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QTcF: Increase from baseline >30 ms | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | QRS: Increase from baseline >25% & to a value >110 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable ECG Values: Part II | HR: Decrease from baseline >25% & to a value <60 bpm | 14 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QT: Increase from baseline >60 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | HR: Increase from baseline >25% & to a value >100 bpm | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | HR: Decrease from baseline >25% & to a value <60 bpm | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | PR: Increase from baseline >25% & to a value >200 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QRS: Increase from baseline >25% & to a value >110 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QT: Increase from baseline >30 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >480 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QTcF: Increase from baseline >30 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QTcF: Increase from baseline >60 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >450 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >480 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QRS: Increase from baseline >25% & to a value >110 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >480 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >480 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | PR: Increase from baseline >25% & to a value >200 ms | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QTcF: Increase from baseline >30 ms | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | HR: Increase from baseline >25% & to a value >100 bpm | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QTcF: Increase from baseline >60 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | HR: Decrease from baseline >25% & to a value <60 bpm | 7 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >450 ms | 3 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QT: Increase from baseline >30 ms | 9 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QT: Increase from baseline >60 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >450 ms | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QRS: Increase from baseline >25% & to a value >110 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QTcF: Increase from baseline >60 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >450 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >480 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | PR: Increase from baseline >25% & to a value >200 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QT: Increase from baseline >60 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QT: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >450 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QTcF: New Interval >480 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | HR: Increase from baseline >25% & to a value >100 bpm | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QTcF: Increase from baseline >30 ms | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | HR: Decrease from baseline >25% & to a value <60 bpm | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Notable ECG Values: Part II | QT: Increase from baseline >30 ms | 0 Participants |
Number of Participants With Notable Electrocardiograms (ECG) Values: Part I
Number of participants with notable ECG values were reported in this outcome measure. Abnormality categories were: Heart rate (HR): increase from baseline \>25% and to a value \>100 bpm, decrease from baseline \>25% and to a value \<60 bpm; PR: increase from baseline \>25% and to a value \>200 millisecond (ms); QRS: increase from baseline \>25% and to a value \>110 ms; QT: increase from baseline \>30 ms, increase from baseline \>60 ms, new interval \>450 ms, new interval \>480 ms, new interval \>500 ms; and Corrected QT interval by Fridericia (QTcF): increase from baseline \>30 ms, increase from baseline \>60 ms, new interval \>450 ms, new interval \>480 ms, new interval \>500 ms. New = newly occurred post-baseline value.
Time frame: During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Population: Safety set included all participants who received at least 1 dose of encorafenib or binimetinib for Part I and had at least 1 valid post-baseline safety assessment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | HR: Increase from baseline >25% & to a value >100 bpm | 10 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | HR: Decrease from baseline >25% & to a value <60 bpm | 37 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | PR: Increase from baseline >25% & to a value >200 ms | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QRS: Increase from baseline >25% & to a value >110 ms | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: Increase from baseline >30 ms | 61 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: Increase from baseline >60 ms | 29 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: New Interval >450 ms | 24 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: New Interval >480 ms | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: New Interval >500 ms | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: Increase from baseline >30 ms | 46 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: Increase from baseline >60 ms | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: New Interval >450 ms | 28 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: New Interval >480 ms | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: New Interval >500 ms | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: Increase from baseline >60 ms | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | HR: Increase from baseline >25% & to a value >100 bpm | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: New Interval >480 ms | 3 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | HR: Decrease from baseline >25% & to a value <60 bpm | 23 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: New Interval >480 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | PR: Increase from baseline >25% & to a value >200 ms | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QRS: Increase from baseline >25% & to a value >110 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: New Interval >450 ms | 15 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: Increase from baseline >30 ms | 48 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: Increase from baseline >30 ms | 31 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: Increase from baseline >60 ms | 15 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QTcF: New Interval >500 ms | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Notable Electrocardiograms (ECG) Values: Part I | QT: New Interval >450 ms | 4 Participants |
Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I
Parameters evaluated were: Activated partial thromboplastin time (APTT) (seconds \[sec\]) - CTCAE graded high, fibrinogen (gram per liter \[g/L\]) - CTCAE graded low, hemoglobin (g/L) - CTCAE graded low, hemoglobin (g/L) - CTCAE graded high, prothrombin international normalized ratio (PINR) - CTCAE graded high, lymphocytes (10\^9 cells/L) - CTCAE graded low, lymphocytes (10\^9 cells/L) - CTCAE graded high, neutrophils (10\^9 cells/L) - CTCAE graded low, platelets (10\^9 cells/L) - CTCAE graded low, leukocytes (10\^9 cells/L) - CTCAE graded low, leukocytes (10\^9 cells/L) - CTCAE graded high. CTCAE version 4.03 was used: grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening consequences; grade 0 = values not meeting any of the criteria for grade 1 or higher. Baseline = last non-missing value prior to the first dose of study treatment.
Time frame: Baseline up to last dose (maximum treatment exposure for Part I was 403.7 weeks)
Population: Safety set included all participants who received at least 1 dose of encorafenib or binimetinib for Part I and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Missing | 28 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 0 | 28 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 1 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 2 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 3 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Missing | 30 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 0 | 21 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 1 | 28 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 2 | 18 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 3 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 0 | 46 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 0 | 70 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 0 | 44 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Missing | 31 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 0 | 23 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 1 | 22 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 2 | 13 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 3 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Missing | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 0 | 61 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Missing | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 0 | 52 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 2 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Missing | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 0 | 59 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 1 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 0 | 52 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 1 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Missing | 9 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 0 | 66 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Missing | 9 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 1 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 0 | 54 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 3 | 10 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Missing | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Missing | 9 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | APTT -CTCAE graded high | Worst post-baseline value Missing | 25 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 0 | 36 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 0 | 68 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 1 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 2 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 2 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Fibrinogen - CTCAE graded low | Worst post-baseline value Missing | 30 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 0 | 17 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 1 | 39 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Missing | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 2 | 20 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 3 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded high | Worst post-baseline value Missing | 9 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 0 | 80 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 0 | 62 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 0 | 61 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 1 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 0 | 78 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 2 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Hemoglobin - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 1 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 0 | 34 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Neutrophils - CTCAE graded low | Worst post-baseline value Missing | 10 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | PINR -CTCAE graded high | Worst post-baseline value Missing | 47 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 0 | 27 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Platelets - CTCAE graded low | Worst post-baseline value Grade 0 | 71 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 1 | 24 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Leukocytes - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I | Lymphocytes - CTCAE graded low | Worst post-baseline value Grade 2 | 12 Participants |
Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II
Parameters evaluated were: APTT (sec) - CTCAE graded high, fibrinogen (g/L) - CTCAE graded low, hemoglobin (g/L) - CTCAE graded low, hemoglobin (g/L) - CTCAE graded high, PINR - CTCAE graded high, lymphocytes (10\^9 cells/L) - CTCAE graded low, lymphocytes (10\^9 cells/L) - CTCAE graded high, neutrophils (10\^9 cells/L) - CTCAE graded low, platelets (10\^9 cells/L) - CTCAE graded low, leukocytes (10\^9 cells/L) - CTCAE graded low, leukocytes (10\^9 cells/L) - CTCAE graded high. CTCAE version 4.03 was used: grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening consequences; grade 0 = values not meeting any of the criteria for grade 1 or higher. Baseline = last non-missing value prior to the first dose of study treatment in Part II.
Time frame: Baseline up to last dose (maximum treatment exposure for Part II was 97.0 weeks)
Population: Safety set included all participants who received at least 1 dose of 3rd combination agent for Part II and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 0 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Missing | 24 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 3 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 1 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 0 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Missing | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 0 | 37 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 0 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Missing | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 0 | 33 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Missing | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 0 | 13 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 0 | 31 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 1 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 0 | 27 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 2 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 1 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 0 | 10 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Missing | 9 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Missing | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Missing | 19 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 0 | 29 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Missing | 9 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 3 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 1 | 15 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 2 | 12 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 2 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 1 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 2 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 1 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Missing | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Missing | 5 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 0 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 0 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Missing | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Missing | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 0 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Missing | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 0 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Missing | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Missing | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 0 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 0 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 0 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 0 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Missing | 5 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 1 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 0 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 0 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Missing | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes -CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Missing | 5 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes- CTCAE graded low | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Lymphocytes- CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Fibrinogen: CTCAE graded low | Worst post-baseline value Grade 0 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Leukocytes - CTCAE graded high | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Platelets- CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | PINR- CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Neutrophils- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | APTT- CTCAE graded high | Worst post-baseline value Missing | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II | Hemoglobin- CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I
Parameters evaluated were: albumin (g/L)- CTCAE graded low, alkaline phosphatase (units per liter \[U/L\])- CTCAE graded high, alanine aminotransferase (U/L)- CTCAE graded high, amylase (U/L - CTCAE graded high, aspartate aminotransferase(U/L)- CTCAE graded high, bilirubin (micromole per liter \[umol/L\])- CTCAE graded high, creatinine (umol/L) - CTCAE graded high, creatine kinase (U/L)- CTCAE graded high, gamma glutamyl transferase (U/L)- CTCAE graded high, glucose (millimole per liter \[mmol/L\])- CTCAE graded low, high, potassium (mmol/L)- CTCAE graded low, potassium (mmol/L)- CTCAE graded high, magnesium (mmol/L)- CTCAE graded low, high, phosphate (mmol/L)- CTCAE graded low, sodium (mmol/L)- CTCAE graded low, sodium (mmol/L)- CTCAE graded high, urate (umol/L)- CTCAE graded high. CTCAE version 4.03 was used: grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening consequences; grade 0 = values not meeting any of the criteria for grade 1 or higher.
Time frame: Baseline up to last dose (maximum treatment exposure for Part I was 403.7 weeks)
Population: Safety set included all participants who received at least 1 dose of encorafenib or binimetinib for Part I and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 0 | 32 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 1 | 57 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 0 | 56 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 3 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Missing | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 0 | 65 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 1 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 1 | 18 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 0 | 74 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 2 | 18 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 3 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 0 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 2 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 0 | 20 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 1 | 19 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 2 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 3 | 20 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 4 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 0 | 55 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 1 | 35 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 2 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 0 | 39 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 1 | 28 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 2 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 38 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 27 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 0 | 53 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 1 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 2 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 38 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 30 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 0 | 73 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 0 | 22 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 1 | 30 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 1 | 15 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Missing | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 0 | 54 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 0 | 66 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 1 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 0 | 40 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 1 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 2 | 24 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 3 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 0 | 54 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 1 | 21 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 0 | 66 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 1 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 0 | 75 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 2 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 29 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 1 | 56 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 3 | 15 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 0 | 67 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 1 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 0 | 81 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 0 | 74 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 1 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 0 | 66 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 1 | 15 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 0 | 68 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 0 | 79 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 2 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Bilirubin - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 0 | 62 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 0 | 56 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 0 | 75 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 1 | 15 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 2 | 22 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 1 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 0 | 82 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Creatinine - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 2 | 12 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 0 | 33 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 1 | 18 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 1 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 2 | 13 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded low | Worst post-baseline value Missing | 8 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 0 | 60 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 4 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 1 | 10 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 3 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 0 | 40 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 1 | 29 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Grade 3 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 2 | 12 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Glucose - CTCAE graded high | Worst post-baseline value Missing | 8 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Albumin - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 0 | 43 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 1 | 31 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Phosphate - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 51 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 0 | 53 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 28 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Potassium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 1 | 24 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 1 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 0 | 52 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Urate - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 1 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Amylase - CTCAE graded high | Worst post-baseline value Missing | 20 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 50 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Sodium - CTCAE graded low | Worst post-baseline value Grade 3 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I | Magnesium - CTCAE graded high | Worst post-baseline value Grade 1 | 3 Participants |
Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II
Parameters evaluated were: albumin (g/L)- CTCAE graded low, alkaline phosphatase (U/L)- CTCAE graded high, alanine aminotransferase (U/L)- CTCAE graded high, amylase (U/L) - CTCAE graded high, aspartate aminotransferase(U/L)- CTCAE graded high, bilirubin (umol/L)- CTCAE graded high, creatinine (umol/L) - CTCAE graded high, creatine kinase (U/L)- CTCAE graded high, gamma glutamyl transferase (U/L)- CTCAE graded high, glucose (mmol/L)- CTCAE graded low, high, potassium (mmol/L)- CTCAE graded low, potassium (mmol/L)- CTCAE graded high, magnesium (mmol/L)- CTCAE graded low, high, phosphate (mmol/L)- CTCAE graded low, sodium (mmol/L)- CTCAE graded low, sodium (mmol/L)- CTCAE graded high, urate (umol/L)- CTCAE graded high. CTCAE version 4.03 was used: grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening consequences; grade 0 = values not meeting any of the criteria for grade 1 or higher.
Time frame: Baseline up to last dose (maximum treatment exposure for Part II was 97.0 weeks)
Population: Safety set included all participants who received at least 1 dose of 3rd combination agent for Part II and had at least 1 valid post-baseline safety assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Missing | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 4 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 1 | 14 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 0 | 26 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 4 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 0 | 35 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 0 | 37 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 0 | 20 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 27 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Missing | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 0 | 16 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 0 | 34 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 1 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 0 | 28 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 1 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 1 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 0 | 32 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 3 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 2 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 27 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 1 | 10 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 0 | 27 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 0 | 22 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 0 | 35 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 0 | 24 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 1 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 0 | 20 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Missing | 8 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 1 | 13 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 1 | 25 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 0 | 36 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 2 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 0 | 25 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 2 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 0 | 37 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 0 | 12 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 2 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 0 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 0 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 0 | 10 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 0 | 11 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 0 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 1 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 0 | 10 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 0 | 12 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 0 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 0 | 10 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 0 | 12 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 0 | 12 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 1 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 2 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 3 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 0 | 7 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 1 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 0 | 9 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Missing | 2 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 8 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Capmatinib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 0 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 3 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded low | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Missing | 4 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 1 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded high | Worst post-baseline value Grade 0 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Potassium - CTCAE graded low | Worst post-baseline value Grade 0 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alkaline Phosphatase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded high | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatine Kinase - CTCAE graded high | Worst post-baseline value Grade 0 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Glucose - CTCAE graded low | Worst post-baseline value Grade 0 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Alanine Aminotransferase - CTCAE graded high | Worst post-baseline value Missing | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 3 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Aspartate Aminotransferase - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 0 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 2 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Gamma Glutamyl Transferase - CTCAE graded high | Worst post-baseline value Grade 0 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 0 | 5 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 1 | 2 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 1 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Sodium -CTCAE graded low | Worst post-baseline value Grade 0 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Bilirubin - CTCAE graded high | Worst post-baseline value Grade 0 | 6 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 2 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 1 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Amylase - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Phosphate - CTCAE graded low | Worst post-baseline value Grade 0 | 4 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 2 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Urate - CTCAE graded high | Worst post-baseline value Missing | 1 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 4 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Magnesium - CTCAE graded high | Worst post-baseline value Grade 3 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Creatinine - CTCAE graded high | Worst post-baseline value Grade 1 | 3 Participants |
| Part II: Encorafenib + Binimetinib + Buparlisib | Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II | Albumin- CTCAE graded low | Worst post-baseline value Grade 0 | 3 Participants |
Overall Survival (OS): Part II
OS was defined as the time from the start date of study treatment (3rd agent combined with encorafenib and binimetinib) to date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan Meier method used for estimation.
Time frame: From date of start of treatment to date of death due to any cause or censoring date (maximum treatment exposure for Part II was 97.0 weeks)
Population: For Part II, FAS consisted of all participants who received at least 1 dose of encorafenib or binimetinib or the assigned third agent following the assignment of the triple combination treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Overall Survival (OS): Part II | 10.4 Months |
| Part II: Encorafenib + Binimetinib + Infigratinib | Overall Survival (OS): Part II | 20.8 Months |
| Part II: Encorafenib + Binimetinib + Capmatinib | Overall Survival (OS): Part II | 5.6 Months |
| Part II: Encorafenib + Binimetinib + Buparlisib | Overall Survival (OS): Part II | 2.5 Months |
PFS: Part II
PFS was defined as the time from the start date of study drug in Part II until documented PD or death due to any cause. All participants who had not progressed or died at the time of the data cut-off were censored at the date of last tumor assessment (other than those who were unknown or missing) prior to cut-off date or start date of new anti-neoplastic therapy, whichever is earlier. Per RECIST 1.1, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan Meier method used for estimation.
Time frame: From start of study drug until documented PD or death due to any cause or censoring date (maximum treatment exposure for Part II was 97.0 weeks)
Population: For Part II, FAS consisted of all participants who received at least 1 dose of encorafenib or binimetinib or the assigned third agent following the assignment of the triple combination treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | PFS: Part II | 2.1 Months |
| Part II: Encorafenib + Binimetinib + Infigratinib | PFS: Part II | 2.1 Months |
| Part II: Encorafenib + Binimetinib + Capmatinib | PFS: Part II | 2.1 Months |
| Part II: Encorafenib + Binimetinib + Buparlisib | PFS: Part II | 1.4 Months |
Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I
AR00426032 is metabolite of binimetinib. Maximum treatment exposure for Part I was of 403.7 weeks.
Time frame: C1 (1.5 hrs post-dose on D1; pre-dose, 1.5 hrs post-dose on D15); C2 (pre-dose on D8 and D21); C3 pre-dose on D15; C4 pre-dose on D15; C5 pre-dose on D15; EOT
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C1 D1, 1.5 hr | 551 Nanogram per milliliter | Geometric Coefficient of Variation 88.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C1 D15, Pre-dose | 40.3 Nanogram per milliliter | Geometric Coefficient of Variation 63.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C1 D15, 1.5 hr | 461 Nanogram per milliliter | Geometric Coefficient of Variation 70.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C2 D8, Pre-dose | 39.9 Nanogram per milliliter | Geometric Coefficient of Variation 58.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C2 D21, Pre-dose | 38.9 Nanogram per milliliter | Geometric Coefficient of Variation 54.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C3 D15, Pre-dose | 41.9 Nanogram per milliliter | Geometric Coefficient of Variation 60.4 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C4 D15, Pre-dose | 36.2 Nanogram per milliliter | Geometric Coefficient of Variation 68.6 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C5 D15, Pre-dose | 41.3 Nanogram per milliliter | Geometric Coefficient of Variation 55.7 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: EOT | 33.2 Nanogram per milliliter | Geometric Coefficient of Variation 179.4 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C1 D1, 1.5 hr | 57.6 Nanogram per milliliter | Geometric Coefficient of Variation 93.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C1 D15, Pre-dose | 4.13 Nanogram per milliliter | Geometric Coefficient of Variation 70.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C1 D15, 1.5 hr | 30.6 Nanogram per milliliter | Geometric Coefficient of Variation 110.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C2 D8, Pre-dose | 3.63 Nanogram per milliliter | Geometric Coefficient of Variation 60.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C2 D21, Pre-dose | 4.11 Nanogram per milliliter | Geometric Coefficient of Variation 61 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C3 D15, Pre-dose | 3.71 Nanogram per milliliter | Geometric Coefficient of Variation 59.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C4 D15, Pre-dose | 3.48 Nanogram per milliliter | Geometric Coefficient of Variation 65.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C5 D15, Pre-dose | 3.77 Nanogram per milliliter | Geometric Coefficient of Variation 66.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: EOT | 4.09 Nanogram per milliliter | Geometric Coefficient of Variation 90.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C2 D21, Pre-dose | 4.39 Nanogram per milliliter | Geometric Coefficient of Variation 80.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C1 D1, 1.5 hr | 482 Nanogram per milliliter | Geometric Coefficient of Variation 73.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C1 D1, 1.5 hr | 47.5 Nanogram per milliliter | Geometric Coefficient of Variation 101.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C1 D15, Pre-dose | 43.3 Nanogram per milliliter | Geometric Coefficient of Variation 72.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: EOT | 5.88 Nanogram per milliliter | Geometric Coefficient of Variation 118 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C1 D15, 1.5 hr | 451 Nanogram per milliliter | Geometric Coefficient of Variation 50.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C1 D15, Pre-dose | 4.50 Nanogram per milliliter | Geometric Coefficient of Variation 64 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C2 D8, Pre-dose | 44.8 Nanogram per milliliter | Geometric Coefficient of Variation 73 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C3 D15, Pre-dose | 3.90 Nanogram per milliliter | Geometric Coefficient of Variation 60.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C2 D21, Pre-dose | 53.1 Nanogram per milliliter | Geometric Coefficient of Variation 78.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C1 D15, 1.5 hr | 31.9 Nanogram per milliliter | Geometric Coefficient of Variation 84 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C3 D15, Pre-dose | 38.7 Nanogram per milliliter | Geometric Coefficient of Variation 94.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C5 D15, Pre-dose | 3.36 Nanogram per milliliter | Geometric Coefficient of Variation 67.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C4 D15, Pre-dose | 38.8 Nanogram per milliliter | Geometric Coefficient of Variation 57.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C2 D8, Pre-dose | 4.17 Nanogram per milliliter | Geometric Coefficient of Variation 88.1 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: C5 D15, Pre-dose | 39.2 Nanogram per milliliter | Geometric Coefficient of Variation 76.1 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | AR00426032: C4 D15, Pre-dose | 3.81 Nanogram per milliliter | Geometric Coefficient of Variation 56.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I | Binimetinib: EOT | 52.8 Nanogram per milliliter | Geometric Coefficient of Variation 180.4 |
Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II
AR00426032 is metabolite of binimetinib. Maximum treatment exposure for Part II was of 97.0 weeks.
Time frame: C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 9.97 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 74.9 Nanogram per milliliter | Geometric Coefficient of Variation 34.7 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C5 D1: Pre-dose | 6.05 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C3 D1: Pre-dose | 50.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 5.94 Nanogram per milliliter | Geometric Coefficient of Variation 76.7 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 38.8 Nanogram per milliliter | Geometric Coefficient of Variation 62.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 63.7 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 6.23 Nanogram per milliliter | Geometric Coefficient of Variation 82 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 386 Nanogram per milliliter | Geometric Coefficient of Variation 41.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 3.14 Nanogram per milliliter | Geometric Coefficient of Variation 74.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 150 Nanogram per milliliter | Geometric Coefficient of Variation 36.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 79.0 Nanogram per milliliter | Geometric Coefficient of Variation 36.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 250 Nanogram per milliliter | Geometric Coefficient of Variation 17.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 147 Nanogram per milliliter | Geometric Coefficient of Variation 21.4 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 3.98 Nanogram per milliliter | Geometric Coefficient of Variation 31.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 24.9 Nanogram per milliliter | Geometric Coefficient of Variation 92.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 6.66 Nanogram per milliliter | Geometric Coefficient of Variation 43.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032 C3 D1: Pre-dose | 9.74 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C4 D1: Pre-dose | 46.1 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 32.0 Nanogram per milliliter | Geometric Coefficient of Variation 17.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 44.1 Nanogram per milliliter | Geometric Coefficient of Variation 19.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 18.5 Nanogram per milliliter | Geometric Coefficient of Variation 77 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 3.99 Nanogram per milliliter | Geometric Coefficient of Variation 61.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 41.6 Nanogram per milliliter | Geometric Coefficient of Variation 21.7 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 11.8 Nanogram per milliliter | Geometric Coefficient of Variation 40.3 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C4 D1: Pre-dose | 7.10 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C5 D1: Pre-dose | 60.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 6.86 Nanogram per milliliter | Geometric Coefficient of Variation 61.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 3.80 Nanogram per milliliter | Geometric Coefficient of Variation 111.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 125 Nanogram per milliliter | Geometric Coefficient of Variation 62.1 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 97.3 Nanogram per milliliter | Geometric Coefficient of Variation 32.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 73.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 42.7 Nanogram per milliliter | Geometric Coefficient of Variation 27.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 5.24 Nanogram per milliliter | Geometric Coefficient of Variation 70.7 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 3.51 Nanogram per milliliter | Geometric Coefficient of Variation 36.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 22.4 Nanogram per milliliter | Geometric Coefficient of Variation 200.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 7.66 Nanogram per milliliter | Geometric Coefficient of Variation 117.7 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 410 Nanogram per milliliter | Geometric Coefficient of Variation 48.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 7.52 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 9.98 Nanogram per milliliter | Geometric Coefficient of Variation 142.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 51.1 Nanogram per milliliter | Geometric Coefficient of Variation 9.7 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 2.92 Nanogram per milliliter | Geometric Coefficient of Variation 159.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 30.2 Nanogram per milliliter | Geometric Coefficient of Variation 59.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 11.3 Nanogram per milliliter | Geometric Coefficient of Variation 447.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 39.1 Nanogram per milliliter | Geometric Coefficient of Variation 57.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 13.2 Nanogram per milliliter | Geometric Coefficient of Variation 1550.1 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 143 Nanogram per milliliter | Geometric Coefficient of Variation 496.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 187 Nanogram per milliliter | Geometric Coefficient of Variation 351 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 59.7 Nanogram per milliliter | Geometric Coefficient of Variation 12.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 7.43 Nanogram per milliliter | Geometric Coefficient of Variation 455.1 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 2.95 Nanogram per milliliter | Geometric Coefficient of Variation 165.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 143 Nanogram per milliliter | Geometric Coefficient of Variation 172.4 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 1.07 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 63.9 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 55.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 7.75 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 315 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 413 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D21: Pre-dose | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 3.15 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | 36.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C3 D1: Pre-dose | 47.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 40.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 46.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 8.21 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 12.9 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 1.21 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 33.9 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 1.82 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 42.1 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032 C3 D1: Pre-dose | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 416 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 235 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D21: Pre-dose | 34.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 98.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 15.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 1.21 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 1.27 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 107 Nanogram per milliliter | Geometric Coefficient of Variation 40.9 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 489 Nanogram per milliliter | Geometric Coefficient of Variation 27.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 18.5 Nanogram per milliliter | Geometric Coefficient of Variation 88.4 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 166 Nanogram per milliliter | Geometric Coefficient of Variation 48.9 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 74.6 Nanogram per milliliter | Geometric Coefficient of Variation 34.5 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 295 Nanogram per milliliter | Geometric Coefficient of Variation 29.7 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 13.5 Nanogram per milliliter | Geometric Coefficient of Variation 116.8 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 27.9 Nanogram per milliliter | Geometric Coefficient of Variation 85.6 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032 C3 D1: Pre-dose | 6.15 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 85.6 Nanogram per milliliter | Geometric Coefficient of Variation 53.7 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 11.4 Nanogram per milliliter | Geometric Coefficient of Variation 85.7 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 3.27 Nanogram per milliliter | Geometric Coefficient of Variation 65.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 40.9 Nanogram per milliliter | Geometric Coefficient of Variation 50.8 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 11.5 Nanogram per milliliter | Geometric Coefficient of Variation 39.5 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 430 Nanogram per milliliter | Geometric Coefficient of Variation 26.8 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 9.46 Nanogram per milliliter | Geometric Coefficient of Variation 142.7 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C3 D1: Pre-dose | 37.8 Nanogram per milliliter | Geometric Coefficient of Variation 189.6 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 13.1 Nanogram per milliliter | Geometric Coefficient of Variation 97.8 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 118 Nanogram per milliliter | Geometric Coefficient of Variation 120.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 6.90 Nanogram per milliliter | Geometric Coefficient of Variation 142.3 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 106 Nanogram per milliliter | Geometric Coefficient of Variation 53.3 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 7.10 Nanogram per milliliter | Geometric Coefficient of Variation 122.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 313 Nanogram per milliliter | Geometric Coefficient of Variation 25.6 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 7.79 Nanogram per milliliter | Geometric Coefficient of Variation 87.5 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 6.49 Nanogram per milliliter | Geometric Coefficient of Variation 124.9 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 63.2 Nanogram per milliliter | Geometric Coefficient of Variation 64 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 24.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 18.9 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 8.06 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 8.89 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 1100 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 22.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 27.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 47.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 401 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 1.74 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 11.4 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 797 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 4.36 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 264 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 112 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 132 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 1.44 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 17.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 5.71 Nanogram per milliliter | Geometric Coefficient of Variation 44.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 491 Nanogram per milliliter | Geometric Coefficient of Variation 38 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 5.45 Nanogram per milliliter | Geometric Coefficient of Variation 42.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 4.23 Nanogram per milliliter | Geometric Coefficient of Variation 62.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 734 Nanogram per milliliter | Geometric Coefficient of Variation 45.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 180 Nanogram per milliliter | Geometric Coefficient of Variation 91.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032 C3 D1: Pre-dose | 4.35 Nanogram per milliliter | Geometric Coefficient of Variation 42.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 102 Nanogram per milliliter | Geometric Coefficient of Variation 12.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 49.8 Nanogram per milliliter | Geometric Coefficient of Variation 21.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 9.80 Nanogram per milliliter | Geometric Coefficient of Variation 75.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 35.9 Nanogram per milliliter | Geometric Coefficient of Variation 274.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 50.9 Nanogram per milliliter | Geometric Coefficient of Variation 34.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 41.1 Nanogram per milliliter | Geometric Coefficient of Variation 25.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 67.4 Nanogram per milliliter | Geometric Coefficient of Variation 63.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 34.3 Nanogram per milliliter | Geometric Coefficient of Variation 51.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 19.3 Nanogram per milliliter | Geometric Coefficient of Variation 76.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C3 D1: Pre-dose | 41.9 Nanogram per milliliter | Geometric Coefficient of Variation 49 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 55.9 Nanogram per milliliter | Geometric Coefficient of Variation 54 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 508 Nanogram per milliliter | Geometric Coefficient of Variation 130.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | 6.68 Nanogram per milliliter | Geometric Coefficient of Variation 80.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C4 D1: Pre-dose | 53.8 Nanogram per milliliter | Geometric Coefficient of Variation 10.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | 52.1 Nanogram per milliliter | Geometric Coefficient of Variation 18.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 54.2 Nanogram per milliliter | Geometric Coefficient of Variation 32.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 9.66 Nanogram per milliliter | Geometric Coefficient of Variation 71.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C4 D1: Pre-dose | 5.70 Nanogram per milliliter | Geometric Coefficient of Variation 11.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 6.34 Nanogram per milliliter | Geometric Coefficient of Variation 54.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 266 Nanogram per milliliter | Geometric Coefficient of Variation 32.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 8.87 Nanogram per milliliter | Geometric Coefficient of Variation 76.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 141 Nanogram per milliliter | Geometric Coefficient of Variation 15.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 4.75 Nanogram per milliliter | Geometric Coefficient of Variation 25.4 |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 4.32 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 8.54 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032 C3 D1: Pre-dose | 4.50 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C4 D1: Pre-dose | 5.43 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C5 D1: Pre-dose | 8.89 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | 3.77 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 396 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 4 hrs | 152 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 63.0 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 54.3 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 229 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 261 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 207 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 130 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 167 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 116 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 78.3 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D21: Pre-dose | 40.4 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 58.3 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 63.1 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C3 D1: Pre-dose | 53.4 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C4 D1: Pre-dose | 63.6 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C5 D1: Pre-dose | 42.3 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | 41.0 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 4 hrs | 9.40 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 6.15 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 4.16 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 7.31 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 12.9 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 9.71 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 6.76 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 5.82 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 5.12 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 6.53 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D21: Pre-dose | 3.66 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 174 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 1.63 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C4 D1: Pre-dose | 40.9 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 2.06 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C5 D1: Pre-dose | 28.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D21: Pre-dose | 38.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D21: Pre-dose | 1.47 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | 32.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 29.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 22.1 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 4 hrs | 4.09 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 65.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 77.4 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 1.10 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 331 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 520 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 389 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 4.35 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 28.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 12.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 31.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 8.51 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 4 hrs | 106 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 649 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | 1.48 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 2.52 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C5 D1: Pre-dose | 1.36 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C4 D1: Pre-dose | 2.78 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 1.95 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032 C3 D1: Pre-dose | 1.09 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 1.08 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 19.4 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C3 D1: Pre-dose | 4.82 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 1.99 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | 13.8 Nanogram per milliliter | Geometric Coefficient of Variation 205.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 6.16 Nanogram per milliliter | Geometric Coefficient of Variation 490.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 4 hrs | 6.71 Nanogram per milliliter | Geometric Coefficient of Variation 145.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 98.0 Nanogram per milliliter | Geometric Coefficient of Variation 60 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 21.1 Nanogram per milliliter | Geometric Coefficient of Variation 23.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D21: Pre-dose | 3.18 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 2.67 Nanogram per milliliter | Geometric Coefficient of Variation 72.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 23.3 Nanogram per milliliter | Geometric Coefficient of Variation 20.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 154 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 16.1 Nanogram per milliliter | Geometric Coefficient of Variation 151.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 25.1 Nanogram per milliliter | Geometric Coefficient of Variation 1.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 15.2 Nanogram per milliliter | Geometric Coefficient of Variation 18.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D21: Pre-dose | 13.6 Nanogram per milliliter | Geometric Coefficient of Variation 80.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 16.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 1.73 Nanogram per milliliter | Geometric Coefficient of Variation 48.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 4 hrs | 129 Nanogram per milliliter | Geometric Coefficient of Variation 25.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 4.09 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 3.07 Nanogram per milliliter | Geometric Coefficient of Variation 95 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 3.81 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 273 Nanogram per milliliter | Geometric Coefficient of Variation 24.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | 3.65 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 5.21 Nanogram per milliliter | Geometric Coefficient of Variation 81.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 8.05 Nanogram per milliliter | Geometric Coefficient of Variation 68.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 313 Nanogram per milliliter | Geometric Coefficient of Variation 15.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 42.2 Nanogram per milliliter | Geometric Coefficient of Variation 39.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 53.3 Nanogram per milliliter | Geometric Coefficient of Variation 36.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 161 Nanogram per milliliter | Geometric Coefficient of Variation 54.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 3.19 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 23.1 Nanogram per milliliter | Geometric Coefficient of Variation 5.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 27.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D21: Pre-dose | 1.13 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 3.99 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 1.19 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 58.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 14.1 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 2.09 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D21: Pre-dose | 19.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032 C3 D1: Pre-dose | 4.46 Nanogram per milliliter | Geometric Coefficient of Variation 70.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 6 hrs | 134 Nanogram per milliliter | Geometric Coefficient of Variation 46.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 5.69 Nanogram per milliliter | Geometric Coefficient of Variation 57 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 4 hrs | 241 Nanogram per milliliter | Geometric Coefficient of Variation 28.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 5.50 Nanogram per milliliter | Geometric Coefficient of Variation 62.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 380 Nanogram per milliliter | Geometric Coefficient of Variation 31.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 1.5 hrs | 437 Nanogram per milliliter | Geometric Coefficient of Variation 46.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D21: Pre-dose | 6.64 Nanogram per milliliter | Geometric Coefficient of Variation 56.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 4.19 Nanogram per milliliter | Geometric Coefficient of Variation 79.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 0.5 hr | 158 Nanogram per milliliter | Geometric Coefficient of Variation 90.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 0.5 hr | 7.81 Nanogram per milliliter | Geometric Coefficient of Variation 119 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 48.2 Nanogram per milliliter | Geometric Coefficient of Variation 70 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 4.70 Nanogram per milliliter | Geometric Coefficient of Variation 80.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 51.0 Nanogram per milliliter | Geometric Coefficient of Variation 67.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C3 D1: Pre-dose | 45.0 Nanogram per milliliter | Geometric Coefficient of Variation 91.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 1.5 hrs | 18.3 Nanogram per milliliter | Geometric Coefficient of Variation 135.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 4 hrs | 215 Nanogram per milliliter | Geometric Coefficient of Variation 44.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 18.5 Nanogram per milliliter | Geometric Coefficient of Variation 81.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 58.4 Nanogram per milliliter | Geometric Coefficient of Variation 68.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 446 Nanogram per milliliter | Geometric Coefficient of Variation 59.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 4 hrs | 12.2 Nanogram per milliliter | Geometric Coefficient of Variation 78.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, EOT | 4.24 Nanogram per milliliter | Geometric Coefficient of Variation 85.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C5 D1: Pre-dose | 6.11 Nanogram per milliliter | Geometric Coefficient of Variation 67.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 4.03 Nanogram per milliliter | Geometric Coefficient of Variation 58.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 6 hrs | 7.41 Nanogram per milliliter | Geometric Coefficient of Variation 80.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 46.0 Nanogram per milliliter | Geometric Coefficient of Variation 71.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C4 D1: Pre-dose | 5.78 Nanogram per milliliter | Geometric Coefficient of Variation 83 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C4 D1: Pre-dose | 77.5 Nanogram per milliliter | Geometric Coefficient of Variation 32.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C5 D1: Pre-dose | 73.8 Nanogram per milliliter | Geometric Coefficient of Variation 25.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D21: Pre-dose | 63.2 Nanogram per milliliter | Geometric Coefficient of Variation 51 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 55.2 Nanogram per milliliter | Geometric Coefficient of Variation 66 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, EOT | 29.0 Nanogram per milliliter | Geometric Coefficient of Variation 179.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032b, C1 D15: 8 hrs | 6.73 Nanogram per milliliter | Geometric Coefficient of Variation 75 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 8 hrs | 109 Nanogram per milliliter | Geometric Coefficient of Variation 54.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 19.4 Nanogram per milliliter | Geometric Coefficient of Variation 99.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 4 hrs | 12.3 Nanogram per milliliter | Geometric Coefficient of Variation 75.3 |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D21: Pre-dose | 35.3 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 1.33 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 4 hrs | 4.61 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 16.3 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: 2.5 hrs | 4.73 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: Pre-dose | 36.2 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 22.4 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 522 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D8: Pre-dose | 2.14 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C3 D1: Pre-dose | 42.0 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D16: 24 hrs | 1.56 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D15: Pre-dose | 1.09 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032 C3 D1: Pre-dose | 1.73 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 4 hrs | 99.5 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D16: 24 hrs | 40.5 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D8: Pre-dose | 37.3 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D21: Pre-dose | 1.65 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D15: 2.5 hrs | 178 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 27.3 Nanogram per milliliter | — |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | NA Nanogram per milliliter | — |
| Part II: Encorafenib 450 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D1: Pre-dose | 17.8 Nanogram per milliliter | — |
| Part II: Encorafenib 450 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D1: 1.5 hrs | 1230 Nanogram per milliliter | — |
| Part II: Encorafenib 450 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C2 D15: Pre-dose | 3.74 Nanogram per milliliter | — |
| Part II: Encorafenib 450 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D1: 1.5 hrs | 64.6 Nanogram per milliliter | — |
| Part II: Encorafenib 450 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | AR00426032, C1 D21: Pre-dose | 3.11 Nanogram per milliliter | — |
| Part II: Encorafenib 450 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C1 D21: Pre-dose | 8.91 Nanogram per milliliter | — |
| Part II: Encorafenib 450 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D1: Pre-dose | 54.1 Nanogram per milliliter | — |
| Part II: Encorafenib 450 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II | Binimetinib, C2 D15: Pre-dose | 34.9 Nanogram per milliliter | — |
Plasma Concentration for Buparlisib (BKM): Part II
Maximum treatment exposure for Part II was of 97.0 weeks.
Time frame: C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D1: 1.5 hrs | 213 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 8 hrs | 87.4 Nanogram per milliliter | Geometric Coefficient of Variation 63.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 1.5 hrs | 266 Nanogram per milliliter | Geometric Coefficient of Variation 51.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D16: 24 hrs | 41.8 Nanogram per milliliter | Geometric Coefficient of Variation 82.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: Pre-dose | 49.7 Nanogram per milliliter | Geometric Coefficient of Variation 115.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C2 D1: Pre-dose | 54.7 Nanogram per milliliter | Geometric Coefficient of Variation 134.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 2.5 hrs | 176 Nanogram per milliliter | Geometric Coefficient of Variation 42.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C2 D15: Pre-dose | 99.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D8: Pre-dose | 45.0 Nanogram per milliliter | Geometric Coefficient of Variation 75.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C3 D1: Pre-dose | 81.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C4 D1: Pre-dose | 73.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C5 D1: Pre-dose | 122 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | EOT | 1.84 Nanogram per milliliter | Geometric Coefficient of Variation 53.4 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 4 hrs | 115 Nanogram per milliliter | Geometric Coefficient of Variation 44 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 0.5 hr | 139 Nanogram per milliliter | Geometric Coefficient of Variation 13.4 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 6 hrs | 94.2 Nanogram per milliliter | Geometric Coefficient of Variation 40 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D1: 1.5 hrs | 213 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D8: Pre-dose | 119 Nanogram per milliliter | Geometric Coefficient of Variation 3.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: Pre-dose | 97.3 Nanogram per milliliter | Geometric Coefficient of Variation 16.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 0.5 hr | 229 Nanogram per milliliter | Geometric Coefficient of Variation 21.5 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 1.5 hrs | 312 Nanogram per milliliter | Geometric Coefficient of Variation 10.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 2.5 hrs | 268 Nanogram per milliliter | Geometric Coefficient of Variation 11.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 4 hrs | 235 Nanogram per milliliter | Geometric Coefficient of Variation 39.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 6 hrs | 171 Nanogram per milliliter | Geometric Coefficient of Variation 26.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D15: 8 hrs | 111 Nanogram per milliliter | Geometric Coefficient of Variation 25.5 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C1 D16: 24 hrs | 101 Nanogram per milliliter | Geometric Coefficient of Variation 1.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C2 D1: Pre-dose | 110 Nanogram per milliliter | Geometric Coefficient of Variation 51.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Buparlisib (BKM): Part II | C2 D15: Pre-dose | 138 Nanogram per milliliter | — |
Plasma Concentration for Capmatinib (INC): Part II
Maximum treatment exposure for Part II was of 97.0 weeks.
Time frame: C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D16: 24 hrs | 79.6 Nanogram per milliliter | Geometric Coefficient of Variation 103.1 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 2.5 hrs | 545 Nanogram per milliliter | Geometric Coefficient of Variation 81.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 8 hrs | 120 Nanogram per milliliter | Geometric Coefficient of Variation 50 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 4 hrs | 401 Nanogram per milliliter | Geometric Coefficient of Variation 17.3 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C3 D1: Pre-dose | 114 Nanogram per milliliter | Geometric Coefficient of Variation 113.4 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 6 hrs | 157 Nanogram per milliliter | Geometric Coefficient of Variation 63.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: Pre-dose | 89.3 Nanogram per milliliter | Geometric Coefficient of Variation 35.7 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D8: Pre-dose | 74.3 Nanogram per milliliter | Geometric Coefficient of Variation 97.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C2 D15: Pre-dose | 65.2 Nanogram per milliliter | Geometric Coefficient of Variation 31 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 0.5 hr | 196 Nanogram per milliliter | Geometric Coefficient of Variation 103.8 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D1: 1.5 hrs | 362 Nanogram per milliliter | Geometric Coefficient of Variation 268.6 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C2 D1: Pre-dose | 151 Nanogram per milliliter | Geometric Coefficient of Variation 107.6 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 1.5 hrs | 636 Nanogram per milliliter | Geometric Coefficient of Variation 78.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Capmatinib (INC): Part II | EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 0.5 hr | 1880 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D1: 1.5 hrs | 3600 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D8: Pre-dose | 44.4 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: Pre-dose | 71.4 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 1.5 hrs | 3670 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 4 hrs | 1230 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 6 hrs | 264 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 8 hrs | 268 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D16: 24 hrs | 58.1 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C2 D1: Pre-dose | 38.7 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C2 D15: Pre-dose | 50.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | C5 D1: Pre-dose | 41.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Capmatinib (INC): Part II | EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C4 D1: Pre-dose | 175 Nanogram per milliliter | Geometric Coefficient of Variation 44.8 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D16: 24 hrs | 269 Nanogram per milliliter | Geometric Coefficient of Variation 68.7 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 0.5 hr | 314 Nanogram per milliliter | Geometric Coefficient of Variation 49 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | EOT | 65.4 Nanogram per milliliter | Geometric Coefficient of Variation 155 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C2 D1: Pre-dose | 227 Nanogram per milliliter | Geometric Coefficient of Variation 42 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: Pre-dose | 173 Nanogram per milliliter | Geometric Coefficient of Variation 41.2 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D1: 1.5 hrs | 715 Nanogram per milliliter | Geometric Coefficient of Variation 133.2 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C2 D15: Pre-dose | 166 Nanogram per milliliter | Geometric Coefficient of Variation 80.9 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 4 hrs | 950 Nanogram per milliliter | Geometric Coefficient of Variation 39.1 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D8: Pre-dose | 129 Nanogram per milliliter | Geometric Coefficient of Variation 49.4 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 6 hrs | 487 Nanogram per milliliter | Geometric Coefficient of Variation 23.3 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 2.5 hrs | 1530 Nanogram per milliliter | Geometric Coefficient of Variation 18.4 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C3 D1: Pre-dose | 96.5 Nanogram per milliliter | Geometric Coefficient of Variation 17.9 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 8 hrs | 390 Nanogram per milliliter | Geometric Coefficient of Variation 10.5 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Capmatinib (INC): Part II | C1 D15: 1.5 hrs | 1830 Nanogram per milliliter | Geometric Coefficient of Variation 38.3 |
Plasma Concentration for Encorafenib (LGX): Part I
In results reported below, following abbreviation have been used: Cycle 1 (C1), Day 1 (D1), Day 8 (D8), Day 15 (D15), Day 21 (D21), Cycle 2 (C2), Cycle 3 (C3), Cycle 4 (C4), Cycle 5 (C5) and end of treatment (EOT). Maximum treatment exposure for Part I was of 403.7 weeks.
Time frame: C1 (1.5 hrs post-dose on D1; pre-dose, 1.5 hrs post-dose on D15); C2 (pre-dose on D8 and D21); C3 pre-dose on D15; C4 pre-dose on D15; C5 pre-dose on D15; EOT
Population: Pharmacokinetic analysis set (PAS) consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. All participants reported under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | C1 D15, Pre-dose | 10.0 Nanogram per milliliter | Geometric Coefficient of Variation 81.6 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | C3 D15, Pre-dose | 8.43 Nanogram per milliliter | Geometric Coefficient of Variation 82.3 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | C2 D8, Pre-dose | 9.96 Nanogram per milliliter | Geometric Coefficient of Variation 81.7 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | C4 D15, Pre-dose | 9.21 Nanogram per milliliter | Geometric Coefficient of Variation 100.3 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | C1 D15, 1.5 hr | 2470 Nanogram per milliliter | Geometric Coefficient of Variation 116.7 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | C5 D15, Pre-dose | 8.84 Nanogram per milliliter | Geometric Coefficient of Variation 59.4 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | C2 D21, Pre-dose | 9.04 Nanogram per milliliter | Geometric Coefficient of Variation 84.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | EOT | 19.6 Nanogram per milliliter | Geometric Coefficient of Variation 399.9 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part I | C1 D1, 1.5 hr | 4820 Nanogram per milliliter | Geometric Coefficient of Variation 114.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | EOT | 34.5 Nanogram per milliliter | Geometric Coefficient of Variation 890.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | C1 D1, 1.5 hr | 4480 Nanogram per milliliter | Geometric Coefficient of Variation 124.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | C1 D15, Pre-dose | 13.8 Nanogram per milliliter | Geometric Coefficient of Variation 104.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | C1 D15, 1.5 hr | 2910 Nanogram per milliliter | Geometric Coefficient of Variation 91.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | C2 D8, Pre-dose | 14.7 Nanogram per milliliter | Geometric Coefficient of Variation 117.5 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | C2 D21, Pre-dose | 15.6 Nanogram per milliliter | Geometric Coefficient of Variation 156.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | C3 D15, Pre-dose | 11.2 Nanogram per milliliter | Geometric Coefficient of Variation 114.3 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | C4 D15, Pre-dose | 12.3 Nanogram per milliliter | Geometric Coefficient of Variation 108.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part I | C5 D15, Pre-dose | 11.9 Nanogram per milliliter | Geometric Coefficient of Variation 72.7 |
Plasma Concentration for Encorafenib (LGX): Part II
In results reported below, following abbreviation have been used: Cycle 1 (C1), Day 1 (D1), Day 8 (D8), Day 15 (D15), Day 16 (D16), Day 21 (D21), Cycle 2 (C2), Cycle 3 (C3), Cycle 4 (C4), Cycle 5 (C5). Maximum treatment exposure for Part II was of 97.0 weeks.
Time frame: C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 437 Nanogram per milliliter | Geometric Coefficient of Variation 228.2 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 41.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C4 D1: Pre-dose | 30.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | EOT | 1.77 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 11.3 Nanogram per milliliter | Geometric Coefficient of Variation 45.3 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C3 D1: Pre-dose | 13.9 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 246 Nanogram per milliliter | Geometric Coefficient of Variation 94.6 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 1420 Nanogram per milliliter | Geometric Coefficient of Variation 39.6 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 180 Nanogram per milliliter | Geometric Coefficient of Variation 94.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 11.2 Nanogram per milliliter | Geometric Coefficient of Variation 106.3 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 8.97 Nanogram per milliliter | Geometric Coefficient of Variation 89 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C5 D1: Pre-dose | 749 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 649 Nanogram per milliliter | Geometric Coefficient of Variation 37.5 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 13.5 Nanogram per milliliter | Geometric Coefficient of Variation 193 |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 3050 Nanogram per milliliter | Geometric Coefficient of Variation 59.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 433 Nanogram per milliliter | Geometric Coefficient of Variation 45 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 276 Nanogram per milliliter | Geometric Coefficient of Variation 103.8 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 625 Nanogram per milliliter | Geometric Coefficient of Variation 19.5 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 32.6 Nanogram per milliliter | Geometric Coefficient of Variation 202.9 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 21.3 Nanogram per milliliter | Geometric Coefficient of Variation 150.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 2150 Nanogram per milliliter | Geometric Coefficient of Variation 54.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 3430 Nanogram per milliliter | Geometric Coefficient of Variation 17.6 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 770 Nanogram per milliliter | Geometric Coefficient of Variation 6.2 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 1320 Nanogram per milliliter | Geometric Coefficient of Variation 30 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 15.6 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 18.6 Nanogram per milliliter | Geometric Coefficient of Variation 159.4 |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 25.1 Nanogram per milliliter | Geometric Coefficient of Variation 2066.8 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 7.74 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 2100 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 6.76 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 12.4 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 397 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | EOT | 14.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C3 D1: Pre-dose | 20.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 13.9 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D21: Pre-dose | 10.4 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 211 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 12.7 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 1690 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 1020 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 1860 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 453 Nanogram per milliliter | Geometric Coefficient of Variation 24.3 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 165 Nanogram per milliliter | Geometric Coefficient of Variation 68.8 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C3 D1: Pre-dose | 23.2 Nanogram per milliliter | Geometric Coefficient of Variation 33.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 10.3 Nanogram per milliliter | Geometric Coefficient of Variation 54.4 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 1130 Nanogram per milliliter | Geometric Coefficient of Variation 3.8 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 9.68 Nanogram per milliliter | Geometric Coefficient of Variation 36.5 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 9.95 Nanogram per milliliter | Geometric Coefficient of Variation 40.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 19.9 Nanogram per milliliter | Geometric Coefficient of Variation 210.5 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 262 Nanogram per milliliter | Geometric Coefficient of Variation 345.5 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 1550 Nanogram per milliliter | Geometric Coefficient of Variation 62.4 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 8.10 Nanogram per milliliter | Geometric Coefficient of Variation 43.1 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 808 Nanogram per milliliter | Geometric Coefficient of Variation 55 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 115 Nanogram per milliliter | Geometric Coefficient of Variation 55.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 139 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 6.21 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 266 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 2.91 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 257 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 1160 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 3750 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 7.95 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 5.20 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 2890 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 15.0 Nanogram per milliliter | Geometric Coefficient of Variation 20.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 1770 Nanogram per milliliter | Geometric Coefficient of Variation 62.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 11.7 Nanogram per milliliter | Geometric Coefficient of Variation 56.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 13.5 Nanogram per milliliter | Geometric Coefficient of Variation 35 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 127 Nanogram per milliliter | Geometric Coefficient of Variation 216.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 2500 Nanogram per milliliter | Geometric Coefficient of Variation 27.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 1550 Nanogram per milliliter | Geometric Coefficient of Variation 34.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 667 Nanogram per milliliter | Geometric Coefficient of Variation 20.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 317 Nanogram per milliliter | Geometric Coefficient of Variation 26.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 217 Nanogram per milliliter | Geometric Coefficient of Variation 34.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 14.0 Nanogram per milliliter | Geometric Coefficient of Variation 30.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 8.49 Nanogram per milliliter | Geometric Coefficient of Variation 70.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C3 D1: Pre-dose | 10.1 Nanogram per milliliter | Geometric Coefficient of Variation 72.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C4 D1: Pre-dose | 12.5 Nanogram per milliliter | Geometric Coefficient of Variation 11.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | EOT | 13.9 Nanogram per milliliter | Geometric Coefficient of Variation 66.6 |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C4 D1: Pre-dose | 5.95 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 142 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C5 D1: Pre-dose | 10.7 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 10.7 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 4 hrs | 238 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 878 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 209 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 389 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D21: Pre-dose | 13.6 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 8.55 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | EOT | 8.24 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 8.50 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 622 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 9.28 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 11.1 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 12.5 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 366 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 16.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 601 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C3 D1: Pre-dose | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 15.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C4 D1: Pre-dose | 7.28 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 2030 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 4 hrs | 297 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 981 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C5 D1: Pre-dose | 9.84 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | EOT | 6.81 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 7.85 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 132 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 10.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 199 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 1960 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 82.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D21: Pre-dose | 13.9 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 203 Nanogram per milliliter | Geometric Coefficient of Variation 11.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 473 Nanogram per milliliter | Geometric Coefficient of Variation 1248.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 1450 Nanogram per milliliter | Geometric Coefficient of Variation 3.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D21: Pre-dose | 12.4 Nanogram per milliliter | Geometric Coefficient of Variation 60.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 109 Nanogram per milliliter | Geometric Coefficient of Variation 2.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 7.75 Nanogram per milliliter | Geometric Coefficient of Variation 37.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 4 hrs | 626 Nanogram per milliliter | Geometric Coefficient of Variation 65.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 8.19 Nanogram per milliliter | Geometric Coefficient of Variation 42.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | EOT | 24.5 Nanogram per milliliter | Geometric Coefficient of Variation 259.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 686 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 9.39 Nanogram per milliliter | Geometric Coefficient of Variation 15.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 847 Nanogram per milliliter | Geometric Coefficient of Variation 28.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 10.8 Nanogram per milliliter | Geometric Coefficient of Variation 106.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 478 Nanogram per milliliter | Geometric Coefficient of Variation 39.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 12.3 Nanogram per milliliter | Geometric Coefficient of Variation 24.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D21: Pre-dose | 20.3 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | EOT | NA Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 19.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 7.15 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 8.95 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 6 hrs | 567 Nanogram per milliliter | Geometric Coefficient of Variation 51.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 2.5 hrs | 1510 Nanogram per milliliter | Geometric Coefficient of Variation 48.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | EOT | 16.6 Nanogram per milliliter | Geometric Coefficient of Variation 265 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 8 hrs | 412 Nanogram per milliliter | Geometric Coefficient of Variation 62.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 1.5 hrs | 1850 Nanogram per milliliter | Geometric Coefficient of Variation 69.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 0.5 hr | 175 Nanogram per milliliter | Geometric Coefficient of Variation 252.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D16: 24 hrs | 22.8 Nanogram per milliliter | Geometric Coefficient of Variation 199 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D21: Pre-dose | 17.5 Nanogram per milliliter | Geometric Coefficient of Variation 106.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: Pre-dose | 20.9 Nanogram per milliliter | Geometric Coefficient of Variation 188.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D1: Pre-dose | 11.9 Nanogram per milliliter | Geometric Coefficient of Variation 100.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D8: Pre-dose | 16.2 Nanogram per milliliter | Geometric Coefficient of Variation 116.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C2 D15: Pre-dose | 21.3 Nanogram per milliliter | Geometric Coefficient of Variation 115.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 4 hrs | 596 Nanogram per milliliter | Geometric Coefficient of Variation 51.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C3 D1: Pre-dose | 9.34 Nanogram per milliliter | Geometric Coefficient of Variation 125.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C4 D1: Pre-dose | 13.1 Nanogram per milliliter | Geometric Coefficient of Variation 21.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C5 D1: Pre-dose | 9.15 Nanogram per milliliter | Geometric Coefficient of Variation 44 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D1: 1.5 hrs | 1600 Nanogram per milliliter | Geometric Coefficient of Variation 85.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Plasma Concentration for Encorafenib (LGX): Part II | C1 D15: 4 hrs | 1020 Nanogram per milliliter | Geometric Coefficient of Variation 34.3 |
Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II
BHS697 and CQM157 are metabolites of infigratinib. Maximum treatment exposure for Part II was of 97.0 weeks.
Time frame: C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; EOT
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D1: 1.5 hrs | 15.0 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D8: Pre-dose | 2.67 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D15: Pre-dose | 2.49 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D15: 0.5 hr | 3.39 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D15: 1.5 hrs | 15.2 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D15: 2.5 hrs | 27.5 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D15: 4 hrs | 24.7 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D15: 6 hrs | 20.5 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C1 D21: Pre-dose | 2.05 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C2 D1: Pre-dose | NA Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C2 D15: Pre-dose | 4.65 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, C3 D1: Pre-dose | NA Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | Infigratinib, EOT | 2.42 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D1: 1.5 hrs | 4.83 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D8: Pre-dose | 2.17 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D15: Pre-dose | 1.64 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D15: 0.5 hr | 2.14 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D15: 1.5 hrs | 6.83 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D15: 2.5 hrs | 8.53 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D15: 4 hrs | 6.89 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D15: 6 hrs | 5.57 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C1 D21: Pre-dose | 1.37 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C2 D1: Pre-dose | NA Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C2 D15: Pre-dose | 2.83 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, C3 D1: Pre-dose | NA Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | BHS697, EOT | 1.69 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D1: 1.5 hrs | 13.0 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D8: Pre-dose | 14.1 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D15: Pre-dose | 11.1 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D15: 0.5 hr | 12.0 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D15: 1.5 hrs | 21.3 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D15: 2.5 hrs | 28.3 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D15: 4 hrs | 25.0 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D15: 6 hrs | 32.2 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C1 D21: Pre-dose | 9.65 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C2 D1: Pre-dose | NA Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C2 D15: Pre-dose | 15.5 Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, C3 D1: Pre-dose | NA Nanogram per milliliter |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II | CQM157, EOT | 11.9 Nanogram per milliliter |
Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II
LEQ803 is metabolite of ribociclib. Maximum treatment exposure for Part II was of 97.0 weeks.
Time frame: C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C3 D1: Pre-dose | 7.88 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 4 hrs | 368 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C3 D1: Pre-dose | 1.16 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 1.5 hrs | 220 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 6 hrs | 434 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 4 hrs | 65.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D15: Pre-dose | 103 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 2.5 hrs | 130 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 8 hrs | 311 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 0.5 hr | 86.1 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D15: Pre-dose | 90.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D1: Pre-dose | 6.68 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D16: 24 hrs | 94.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: Pre-dose | 76.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D1: Pre-dose | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D8: Pre-dose | 77.4 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D21: Pre-dose | 105 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D16: 24 hrs | 84.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 4 hrs | 138 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 1.5 hrs | 57.1 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 1.5 hrs | 204 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 6 hrs | 175 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D8: Pre-dose | 64.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, EOT | 1.94 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D21: Pre-dose | 73.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 8 hrs | 135 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 1.5 hrs | 92.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: Pre-dose | 98.4 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C4 D1: Pre-dose | 7.19 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C4 D1: Pre-dose | 1.22 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 2.5 hrs | 321 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 0.5 hr | 75.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, EOT | 10.4 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Ribociclib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 4 hrs | 213 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D1: Pre-dose | 14.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: Pre-dose | 37.1 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D16: 24 hrs | 46.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 0.5 hr | 39.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 0.5 hr | 59.7 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 1.5 hrs | 72.6 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 2.5 hrs | 92.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 6 hrs | 90.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 1.5 hrs | 95.9 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 8 hrs | 79.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 2.5 hrs | 126 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 4 hrs | 84.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 6 hrs | 109 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 1.5 hrs | 117 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 8 hrs | 83.6 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, EOT | 69.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D16: 24 hrs | 25.6 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D8: Pre-dose | 32.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D15: Pre-dose | 45.6 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D1: Pre-dose | 19.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D15: Pre-dose | 41.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C3 D1: Pre-dose | NA Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, EOT | 60.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: Pre-dose | 28.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 1.5 hrs | 70.2 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 4 hrs | 50.8 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D8: Pre-dose | 49.3 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Infigratinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C3 D1: Pre-dose | 2.75 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 8 hrs | 182 Nanogram per milliliter | Geometric Coefficient of Variation 27.1 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 1.5 hrs | 82.7 Nanogram per milliliter | Geometric Coefficient of Variation 0.7 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D15: Pre-dose | 53.7 Nanogram per milliliter | Geometric Coefficient of Variation 51.2 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D16: 24 hrs | 42.5 Nanogram per milliliter | Geometric Coefficient of Variation 13.8 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D16: 24 hrs | 52.7 Nanogram per milliliter | Geometric Coefficient of Variation 90.4 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 4 hrs | 73.5 Nanogram per milliliter | Geometric Coefficient of Variation 20.4 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D1: Pre-dose | 1.59 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D8: Pre-dose | 30.7 Nanogram per milliliter | Geometric Coefficient of Variation 33.5 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 6 hrs | 239 Nanogram per milliliter | Geometric Coefficient of Variation 37.2 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 1.5 hrs | 107 Nanogram per milliliter | Geometric Coefficient of Variation 40.6 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 4 hrs | 205 Nanogram per milliliter | Geometric Coefficient of Variation 96 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 4 hrs | 341 Nanogram per milliliter | Geometric Coefficient of Variation 42.9 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D21: Pre-dose | 43.7 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 2.5 hrs | 718 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, EOT | 5.06 Nanogram per milliliter | Geometric Coefficient of Variation 4.6 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 1.5 hrs | 200 Nanogram per milliliter | Geometric Coefficient of Variation 240.3 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 8 hrs | 95.2 Nanogram per milliliter | Geometric Coefficient of Variation 50.1 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 6 hrs | 111 Nanogram per milliliter | Geometric Coefficient of Variation 27.6 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 0.5 hr | 32.1 Nanogram per milliliter | Geometric Coefficient of Variation 0.7 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, EOT | 1.49 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: Pre-dose | 32.9 Nanogram per milliliter | Geometric Coefficient of Variation 25.7 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D1: Pre-dose | 4.10 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 4 hrs | 140 Nanogram per milliliter | Geometric Coefficient of Variation 23.4 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D8: Pre-dose | 38.1 Nanogram per milliliter | Geometric Coefficient of Variation 9.1 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 1.5 hrs | 68.2 Nanogram per milliliter | Geometric Coefficient of Variation 2.4 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: Pre-dose | 30.7 Nanogram per milliliter | Geometric Coefficient of Variation 24.9 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 2.5 hrs | 126 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D21: Pre-dose | 102 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 0.5 hr | 35.4 Nanogram per milliliter | Geometric Coefficient of Variation 66.6 |
| Part II: Encorafenib + Binimetinib + Capmatinib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D15: Pre-dose | 45.7 Nanogram per milliliter | Geometric Coefficient of Variation 6.8 |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D15: Pre-dose | 36.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, EOT | 23.5 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D1: Pre-dose | 1.07 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D1: Pre-dose | 2.70 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D15: Pre-dose | 28.0 Nanogram per milliliter | — |
| Part II: Encorafenib + Binimetinib + Buparlisib | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, EOT | 45.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D1: Pre-dose | 8.48 Nanogram per milliliter | Geometric Coefficient of Variation 154.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 1.5 hrs | 230 Nanogram per milliliter | Geometric Coefficient of Variation 119.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 4 hrs | 354 Nanogram per milliliter | Geometric Coefficient of Variation 58.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D8: Pre-dose | 100 Nanogram per milliliter | Geometric Coefficient of Variation 49.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: Pre-dose | 104 Nanogram per milliliter | Geometric Coefficient of Variation 54.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 0.5 hr | 179 Nanogram per milliliter | Geometric Coefficient of Variation 65 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 1.5 hrs | 508 Nanogram per milliliter | Geometric Coefficient of Variation 95.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 2.5 hrs | 627 Nanogram per milliliter | Geometric Coefficient of Variation 68.3 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 4 hrs | 707 Nanogram per milliliter | Geometric Coefficient of Variation 62.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 6 hrs | 578 Nanogram per milliliter | Geometric Coefficient of Variation 55.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 8 hrs | 477 Nanogram per milliliter | Geometric Coefficient of Variation 55.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D16: 24 hrs | 120 Nanogram per milliliter | Geometric Coefficient of Variation 64.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D21: Pre-dose | 112 Nanogram per milliliter | Geometric Coefficient of Variation 75.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D1: Pre-dose | 7.00 Nanogram per milliliter | Geometric Coefficient of Variation 377.8 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D15: Pre-dose | 107 Nanogram per milliliter | Geometric Coefficient of Variation 59.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C3 D1: Pre-dose | 4.06 Nanogram per milliliter | Geometric Coefficient of Variation 172.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C4 D1: Pre-dose | 1.59 Nanogram per milliliter | Geometric Coefficient of Variation 31.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C5 D1: Pre-dose | 2.16 Nanogram per milliliter | Geometric Coefficient of Variation 35.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, EOT | 29.0 Nanogram per milliliter | Geometric Coefficient of Variation 292.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 1.5 hrs | 47.5 Nanogram per milliliter | Geometric Coefficient of Variation 97.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 4 hrs | 81.1 Nanogram per milliliter | Geometric Coefficient of Variation 55.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D8: Pre-dose | 53.7 Nanogram per milliliter | Geometric Coefficient of Variation 36.5 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: Pre-dose | 55.1 Nanogram per milliliter | Geometric Coefficient of Variation 33.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 0.5 hr | 60.8 Nanogram per milliliter | Geometric Coefficient of Variation 36.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 1.5 hrs | 112 Nanogram per milliliter | Geometric Coefficient of Variation 46.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 2.5 hrs | 133 Nanogram per milliliter | Geometric Coefficient of Variation 45.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 4 hrs | 152 Nanogram per milliliter | Geometric Coefficient of Variation 31.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 6 hrs | 145 Nanogram per milliliter | Geometric Coefficient of Variation 27.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 8 hrs | 128 Nanogram per milliliter | Geometric Coefficient of Variation 27.6 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D16: 24 hrs | 63.1 Nanogram per milliliter | Geometric Coefficient of Variation 36.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D21: Pre-dose | 58.1 Nanogram per milliliter | Geometric Coefficient of Variation 39.1 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D15: Pre-dose | 58.3 Nanogram per milliliter | Geometric Coefficient of Variation 42.7 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C3 D1: Pre-dose | 7.57 Nanogram per milliliter | Geometric Coefficient of Variation 61.4 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C4 D1: Pre-dose | 5.72 Nanogram per milliliter | Geometric Coefficient of Variation 6.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C5 D1: Pre-dose | 6.07 Nanogram per milliliter | Geometric Coefficient of Variation 28.9 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, EOT | 20.6 Nanogram per milliliter | Geometric Coefficient of Variation 152.2 |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 4 hrs | 63.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D21: Pre-dose | 52.9 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D21: Pre-dose | 69.9 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D16: 24 hrs | 91.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 4 hrs | 268 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D15: Pre-dose | 66.8 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: 2.5 hrs | 393 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D15: Pre-dose | 64.7 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 1.5 hrs | 185 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: 2.5 hrs | 137 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D15: Pre-dose | 49.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D16: 24 hrs | 59.6 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D8: Pre-dose | 47.2 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D8: Pre-dose | 80.5 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 1.5 hrs | 59.0 Nanogram per milliliter | — |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D15: Pre-dose | 113 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D21: Pre-dose | 80.2 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D1: 1.5 hrs | 63.6 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D8: Pre-dose | 127 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, EOT | 22.8 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D15: Pre-dose | 102 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D15: Pre-dose | 61.1 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C2 D1: Pre-dose | 80.8 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C2 D1: Pre-dose | 132 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D21: Pre-dose | 115 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, EOT | 31.2 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | LEQ803, C1 D8: Pre-dose | 71.2 Nanogram per milliliter | — |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II | Ribociclib, C1 D1: 1.5 hrs | 784 Nanogram per milliliter | — |
Progression-Free Survival (PFS): Part I
PFS was defined as the time from the start date of study drug in Part I until documented PD or death due to any cause. All participants who had not progressed or died at the time of the data cut-off were censored at the date of last tumor assessment (other than those who were unknown or missing) prior to cut-off date or start date of new anti-neoplastic therapy, whichever is earlier. Per RECIST 1.1, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan Meier method used for estimation.
Time frame: From start of study drug until documented PD or death due to any cause or censoring date (maximum treatment exposure for Part I was 403.7 weeks)
Population: For Part I, FAS consisted of all participants who received at least 1 dose (partial or full) of encorafenib or binimetinib.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Progression-Free Survival (PFS): Part I | 11.1 Months |
| Part II: Encorafenib + Binimetinib + Infigratinib | Progression-Free Survival (PFS): Part I | 3.3 Months |
Summary of Genomic Biomarkers From Tumor Samples: Part I
Number of participants with multiple alterations in genomic biomarkers like biomarker BRAF, CCND1, CDK4, EGFR, FGFR1, FGFR4, KRAS, MET, NRAS, PIK3CA, and PTEN were reported and alterations included copy number variant/copy number ratio (CNV/CNR), rearrangement, short variant. It was not necessary that all biomarkers had all alterations. Baseline = last non-missing value prior to the first dose of study treatment.
Time frame: Baseline up to end of treatment (EOT) (maximum treatment exposure for Part I was 403.7 weeks)
Population: For Part I, FAS consisted of all participants who received at least 1 dose (partial or full) of encorafenib or binimetinib.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: CNV/CNR at Baseline | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: CNV/CNR at EOT | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140482508-140482692 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140487121-140487285 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140487916-140488167 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140488878-140489055 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline cchr7:140489413-140489576 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140490446-140490656 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140491528-140491878 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140491580-140491878 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140492969-140493301 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140481691-140482150 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482057-140482467 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482081-140482482 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482088-140482296 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482167-140482382 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482495-140482731 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482644-140482867 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140483058-140483257 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140486136-140486408 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140486274-140486561 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140489019-140489575 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140489219-140489431 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140489830-140490002 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140491411-140491879 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140492091-140492240 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140492379-140492708 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140492714-140492997 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140493601-140493951 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140493858-140494232 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at Baseline V600E | 46 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at Baseline V600G | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at Baseline V600K | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at Baseline V600R | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at EOT V600E | 18 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at EOT V600K | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at EOT V600R | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | CCND1: CNV/CNR at Baseline | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | CDK4: CNV/CNR at Baseline | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | EGFR: CNV/CNR at Baseline | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | EGFR: CNV/CNR at EOT | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | FGFR1: CNV/CNR at Baseline | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | FGFR1: CNV/CNR at EOT | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | FGFR4: CNV/CNR at Baseline | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | KRAS: CNV/CNR at Baseline | 2 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | MET: CNV/CNR at Baseline | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | MET: CNV/CNR at EOT | 3 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | MET: Rearrangement/Genomic Position at EOT chr7:116321020-116321260 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | NRAS: CNV/CNR at Baseline | 0 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | PIK3CA: CNV/CNR at Baseline | 1 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | PTEN: CNV/CNR at Baseline | 4 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | PTEN: CNV/CNR at EOT | 5 Participants |
| Part II: Encorafenib + Binimetinib + Ribociclib | Summary of Genomic Biomarkers From Tumor Samples: Part I | PTEN: Rearrangement/Genomic Position at EOT chr10:89720538-89720776 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140492379-140492708 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: CNV/CNR at Baseline | 9 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | MET: CNV/CNR at EOT | 5 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: CNV/CNR at EOT | 3 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140492714-140492997 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140482508-140482692 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | EGFR: CNV/CNR at EOT | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140487121-140487285 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140493601-140493951 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140487916-140488167 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | PTEN: CNV/CNR at EOT | 10 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140488878-140489055 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140493858-140494232 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline cchr7:140489413-140489576 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | FGFR1: CNV/CNR at Baseline | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140490446-140490656 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at Baseline V600E | 53 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140491528-140491878 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | MET: Rearrangement/Genomic Position at EOT chr7:116321020-116321260 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140491580-140491878 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at Baseline V600G | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at Baseline chr7:140492969-140493301 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | FGFR1: CNV/CNR at EOT | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140481691-140482150 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at Baseline V600K | 7 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482057-140482467 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | PTEN: CNV/CNR at Baseline | 13 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482081-140482482 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at Baseline V600R | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482088-140482296 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | FGFR4: CNV/CNR at Baseline | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482167-140482382 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at EOT V600E | 19 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482495-140482731 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | NRAS: CNV/CNR at Baseline | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140482644-140482867 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at EOT V600K | 4 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140483058-140483257 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | KRAS: CNV/CNR at Baseline | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140486136-140486408 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Short variant/amino acid change at EOT V600R | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140486274-140486561 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | PTEN: Rearrangement/Genomic Position at EOT chr10:89720538-89720776 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140489019-140489575 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | CCND1: CNV/CNR at Baseline | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140489219-140489431 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | MET: CNV/CNR at Baseline | 6 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140489830-140490002 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | CDK4: CNV/CNR at Baseline | 2 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140491411-140491879 | 1 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | PIK3CA: CNV/CNR at Baseline | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | BRAF: Rearrangement/Genomic Position at EOT chr7:140492091-140492240 | 0 Participants |
| Part II: Encorafenib + Binimetinib + Infigratinib | Summary of Genomic Biomarkers From Tumor Samples: Part I | EGFR: CNV/CNR at Baseline | 3 Participants |
Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II
Time frame: C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Population: PAS consisted of all participants who had at least one blood sample providing evaluable PK data. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified study treatment or metabolites for respective arms.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Ribociclib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Ribociclib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Buparlisib | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Ribociclib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.33 Hour |
| Part II: Encorafenib + Binimetinib + Infigratinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 2.75 Hour |
| Part II: Encorafenib + Binimetinib + Infigratinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 2.75 Hour |
| Part II: Encorafenib + Binimetinib + Infigratinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.54 Hour |
| Part II: Encorafenib + Binimetinib + Infigratinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Buparlisib | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Capmatinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib metabolite, BHS697 | 2.50 Hour |
| Part II: Encorafenib + Binimetinib + Capmatinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Capmatinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Capmatinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Capmatinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib | 2.50 Hour |
| Part II: Encorafenib + Binimetinib + Capmatinib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Infigratinib metabolite, CQM157 | 5.75 Hour |
| Part II: Encorafenib + Binimetinib + Buparlisib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Buparlisib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 1.53 Hour |
| Part II: Encorafenib + Binimetinib + Buparlisib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.50 Hour |
| Part II: Encorafenib + Binimetinib + Buparlisib | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 4.00 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 300 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.92 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Capmatinib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Capmatinib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.50 Hour |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 2.37 Hour |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.38 Hour |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.38 Hour |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 5.92 Hour |
| Part II: Encorafenib 100 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 5.92 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 2.45 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.47 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.47 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 4.98 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.47 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 3.18 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.00 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 3.18 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 400 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.50 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.58 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 4.12 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Encorafenib | 1.58 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.65 Hour |
| Part II: Encorafenib 200 mg/ Binimetinib 45 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 3.65 Hour |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib | 0.50 Hour |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib | 1.08 Hour |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Ribociclib metabolite, LEQ803 | 1.08 Hour |
| Part II: Encorafenib 300 mg/ Binimetinib 30 mg + Ribociclib 600 mg | Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II | Binimetinib metabolite, AR00426032 | 1.08 Hour |
Time to Response (TTR): Part I
TTR was defined as the time between the start date of study drug in Part I and first documented response (CR or PR). RECIST v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis) and b) PR = at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Kaplan Meier method used for estimation.
Time frame: From start date of study drug till first documented response (CR or PR) (maximum treatment exposure for Part I was 403.7 weeks)
Population: For Part I, FAS consisted of all participants who received at least 1 dose (partial or full) of encorafenib or binimetinib. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure who were responders.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | Time to Response (TTR): Part I | 1.4 Months |
| Part II: Encorafenib + Binimetinib + Infigratinib | Time to Response (TTR): Part I | 0.72 Months |
TTR: Part II
TTR was defined as the time between the start date of study drug in Part II and first documented response (CR or PR). RECIST v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must had a reduction in short axis to \<10 mm. Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis) and b) PR = at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Kaplan Meier method used for estimation.
Time frame: From start date of study drug till first documented response (CR or PR) (maximum treatment exposure for Part II was 97.0 weeks)
Population: For Part II, FAS consisted of all participants who received at least 1 dose of encorafenib or binimetinib or the assigned third agent following the assignment of the triple combination treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure who were responders.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part II: Encorafenib + Binimetinib + Ribociclib | TTR: Part II | 4.1 Months |