Advanced Solid Tumors
Conditions
Keywords
Advanced Solid Tumors, Pembrolizumab, ARRY-382, CSF-1R, CSF1R, cfms
Brief summary
This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in adult patients with selected advanced solid tumors (Part A/Phase 1b); and to estimate the efficacy of the combination in three separate cohorts: 1) patients with advanced solid tumors that have progressed on prior PD-1/PD-L1inhibitors, 2) patients with platinum-resistant ovarian cancer and 3) patients with pancreatic ductal adenocarcinoma (Phase 2).
Detailed description
ARRY-382 is an inhibitor of CSF1R (colony-stimulating factor-1 receptor). Each phase of the study consists of a 28-day screening period; 21-day treatment cycles with the combination of ARRY-382 and pembrolizumab until disease progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, or death (or other discontinuation criteria are met), and a 30-day safety follow-up period. Patients in all cohorts/phases will be monitored for overall survival (OS) until 1 year after the date of the last patient's first visit.
Interventions
ARRAY-382 will be taken by mouth once daily at a fixed dose.
Pembrolizumab will be administered intravenously over 30 minutes every 3 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
Key Inclusion Criteria All Study Parts: * Diagnosis of cancer that has been histologically or cytologically confirmed * Eastern Cooperative Oncology Group Performance Status of 0 or 1 Part A (1 of the following): * Ovarian cancer, triple-negative breast cancer, head and neck squamous cell cancer, bladder cancer, metastatic colorectal cancer, pancreatic ductal adenocarcinoma, or gastric cancer that is measurable or evaluable, nonmeasurable as defined by RECIST v1.1 and meets 1 of the following criteria: * is refractory to standard of care * no standard therapy available * patient refuses standard therapy * Advanced, unresectable, or metastatic melanoma with or without prior treatment and measurable or evaluable, nonmeasurable disease as defined by RECIST v1.1 * Advanced/metastatic PD-L1-positive NSCLC (defined as a tumor proportion score \[TPS\] ≥ 50%) with measurable or evaluable, non-measurable disease as defined by RECIST v1.1 (1 of the following): * 1\) No prior systemic chemotherapy if tumor does not have EGFR or ALK genomic aberrations * 2\) Disease progression on or after platinum-containing chemotherapy; * 3\) If tumor has EGFR or ALK genomic aberrations, disease progression on an FDA-approved therapy for EGFR or ALK genomic tumor aberrations Phase 2 (1 of the following): * Advanced/metastatic solid tumor with PD as defined by RECIST 1.1 or irRC on an anti-PD-1- or anti-PD-L1-containing regimen as their most recent prior therapy * Advanced/metastatic epithelial ovarian cancer, peritoneal cancer or tubal cancer with measurable disease as defined by RECIST 1.1, that had progressed within 6 months of completing ≥ 4 cycles of platinum-based therapy * Advanced/metastatic PDA that is locally advanced, unresectable or metastatic with measurable disease as defined by RECIST v1.1 in patients who have received at least one prior line of systemic therapy for their disease Key
Exclusion criteria
1. Prior treatment as follows: * Part A: an immune CPI (e.g., PD-1, PD-L1, or cytotoxic T-lymphocyte antigen 4 \[CTLA-4\] inhibitor). NOTE: For patients with melanoma, prior treatment with ipilimumab is allowed if it was administered as adjuvant therapy and treatment was completed at least 3 months prior to enrollment. * Phase 2: * A CSF-1R inhibitor or CSF-1 (or MCSF) inhibitor. * prOVCA and PDA patients only: an immune CPI (e.g., PD-1, PD-L1, or CTLA-4 inhibitor) 2. Symptomatic brain metastasis at screening 3. Active autoimmune disease, documented history of autoimmune syndrome or disease, or a chronic medical condition that requires chronic steroid therapy or immunosuppressive medication 4. History of pneumonitis or interstitial lung disease 5. Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study 6. Ocular melanoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT) | Cycle 1 (up to 21 days) | DLT: adverse event (AE) or abnormal laboratory value not clearly attributable to an extraneous cause, such as disease progression, intercurrent illness, or concomitant medications occurring during 21 days of Cycle 1, met 1 of the criteria A) nonhematologic AEs: recurring grade 2 pneumonitis, grade 3 events (irAE, QTcF prolongation, rash; other grade 3/4 except alopecia, nausea, diarrhea, vomiting, tumor flare, pseudoprogression, endocrinopathy); B) hematology AEs/laboratory abnormalities: grade 4 events except lymphopenia, neutropenia, electrolyte imbalances or abnormalities, grade 3 thrombocytopenia, febrile neutropenia, grade 4 AST/ALT elevation, grade 3 AST/ALT elevation lasting \>7 days, associated with bilirubin levels\>=2\*ULN or international normalized ratio \>1.5, grade 3 bilirubin elevation \>=3, CK elevation \>=grade 3 lasting, increase in creatinine \>=1.5\*baseline value, dose delay (dose interruption for \>14 days) or other (inability to receive at least 67% of ARRY-382 doses). |
| Phase 2 Cohorts: Objective Response Rate (ORR) | From day of first dose to 30 days after last dose (maximum up to 13.5 months) | ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 millimeter (mm). PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS) | From day of first dose until disease progression or death due to any cause or till last tumor assessment date (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | PFS was defined as the time from the date of first dose of study drug to the earliest date of disease progression per RECIST v1.1, or death due to any cause, whichever occurs first. If a participant did not have a PFS event at the time of the analysis cut-off or at the start of any new anticancer therapy, PFS was censored at the date of last adequate tumor assessment. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. |
| Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS) | From day of first dose till death due to any cause or date of last contact (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | OS was defined as the time from the start of treatment to the date of death due to any cause. If a death was not observed by the date of the analysis cut-off, OS was censored at the date of last contact. OS was estimated using the Kaplan-Meier method. |
| Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR) | From day of first dose till up to end of study treatment (for Phase 1b: maximum up to 33.7 months, for Phase 2: maximum up to 12.5 months) | irRR was defined as the percentage of participants who achieved immune-related best overall response (irBOR) of immune-related CR (irCR) or immune-related PR (irPR), as determined by the investigator per immune related response criteria (irRC). irBOR was the best response using irRC recorded from the start of study treatment until the end of treatment. irCR was the disappearance of all target lesions, irPR was a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation. |
| Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS) | From the start of treatment to the time of first documented progression, or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | irPFS was defined as the time from the start of treatment to the time of first documented progression per irRC, or death due to any cause. irRC criteria for progression for 1) Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%); 2) New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. For the analysis of irPFS, Kaplan-Meier method was used. |
| Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment discontinuation (before 13.5 months) | Tumor markers were measured for tumor type from serum samples obtained from participants in Phase 2. Mean change from baseline was reported in this outcome measure. |
| Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | Abnormalities: Albumin (hypoalbuminemia),Alkaline phosphatase (ALP increased), Alanine aminotransferase (ALT increased), Aspartate aminotransferase (AST increased),Total bilirubin (TBL increased), Creatinine (increased), Corrected calcium (hypocalcemia/hypercalcemia), Creatine kinase (CK increased), Glucose (hypoglycemia/hyperglycemia), Amylase (increased), Lipase (increased) ,Phosphate (hypophosphatemia), Magnesium (hypomagnesemia/hypermagnesemia), Potassium (hypokalemia/hyperkalemia), Sodium (hyponatremia/hypernatremia). Participants with all grades and grade 3/4 abnormalities were reported. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. |
| Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | Hematology abnormalities: Hemoglobin (anemia/hemoglobin increased), Platelets (count decreased), Leukocytes (count decreased/increased), Neutrophils (count decreased), Lymphocytes (count increased/decreased). Coagulation abnormalities: International Normalized Ratio (INR increased), Partial thromboplastin time(PTT)/Activated partial thromboplastin Time (aPTT, time prolonged). Abnormalities were graded by CTCAE grade 4.03 as Grade 1= mild; Grade 2 = moderate; Grade 3/Grade 4 = severe/life-threatening. Participants with all grades and grade 3/4 abnormalities were reported. |
| Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | Liver function parameters/abnormalities: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): \>3\* upper limit of normal (ULN), \>5\*ULN, \>8\*ULN, \>10\*ULN, \>20\*ULN; Bilirubin \>1.5\*ULN, \>2\*ULN; Alkaline phosphatase (ALP) \>2\*ULN, \>3\*ULN. |
| Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Baseline, 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | Thyroid panel laboratory parameters/abnormalities: thyrotropin, free triiodothyronine (T3), free thyroxine (T4). Shift in thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing is reported in this outcome measure. |
| Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding | First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | Urinalysis laboratory parameters/abnormalities: Decimal logarithm of reciprocal of hydrogen ion activity (pH), specific gravity, protein, glucose, ketones, nitrite, blood, leukocyte esterase, microscopy (if urine tested positive for blood or protein). Clinical significance was judged by investigator. |
| Phase 1b, Part A: Objective Response Rate (ORR) | From day of first dose to 30 days after last dose (maximum up to 34.7 months) | ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator review of radiographic disease assessments per RECIST v1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively. |
| Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hour(hr) (±5 min), 2 hours(hrs) (±10 min), 4 hrs (±20 min) and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2 | The lower limit of quantitation (LLOQ) for analyte ARRY-382 was 5.00 nanogram per milliliter (ng/mL). |
| Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2 | Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469099 was reported in this outcome measure. The LLOQ for analyte AR00469099 was 1.00 ng/mL. |
| Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2 | Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469100 was reported in this outcome measure. The LLOQ for analyte AR00469100 was 1.00 ng/mL. |
| Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2 | Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00470870 was reported in this outcome measure. The LLOQ for analyte AR00470870 was 1.00 ng/mL. |
| Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | 0 to 24 hrs after administration of ARRY-382 on Day 1 of Cycle 2 | AUCtau was defined as area under the plasma concentration-time curve over the dosing interval, where dosing interval was 24 hours. |
| Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2 | Cmax was obtained from plasma concentration time curve. Cmax at single dose was reported at Cycle1 Day 1 and Cmax at steady state was reported at Cycle 2 Day 1. |
| Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Pre dose of ARRY-382 (120 minutes prior to administration) on Day 1 of Cycle 2 | Measured concentration at the pre-dose at steady-state. |
| Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2 | Tmax was obtained from plasma concentration time curve. Tmax at single dose was reported at Cycle 1 Day 1 and Tmax at steady state was reported at Cycle 2 Day 1. |
| Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Pre dose of ARRY-382 (120 minutes prior to administration),1 hrs (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2 | Different MR reported for single dose calculated at Cycle 1 Day 1 were as follows: 1) MRAUClast = ratio of AUClast values of the metabolite compared to parent, corrected for molecular weight, where AUClast was area under the plasma concentration-time curve from zero to the last measurable time point; 2) MRCmax = ratio of Cmax values of the metabolite compared to parent, corrected for molecular weight. Different MR reported for steady state calculated at Cycle 2 Day 1 were as follows: 1) MRAUCtau,ss = ratio of AUCtau,ss values of the metabolite compared to parent, corrected for molecular weight, where AUCtau was area under the plasma concentration-time curve over a dosing interval at steady-state; 2) MRCmax,ss = Ratio of Cmax,ss values of the metabolite compared to parent, corrected for molecular weight. |
| Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Pre dose of ARRY-382 (120 minutes prior to administration),1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2 | Accumulation ratio was calculated and reported for Cmax as RCmax and for AUC as RAUC. RCmax = Cmax at steady-state on Day 1 of Cycle 2 divided by Cmax on Day 1 of Cycle 1. RAUC = AUC from zero to 8 hours after drug administration at steady-state on Day 1 of Cycle 2 divided by AUC from zero to 8 hours after drug administration on Day 1 of Cycle 1. |
| Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, body temperature and weight. Low SBP: less than or equal to (\<=)90 millimeter of mercury (mmHg) with decrease from baseline of \>=20 mmHg. High SBP: \>=160 mmHg with increase from baseline of \>=20 mmHg. Low DBP: \<=50 mmHg with decrease from baseline of \>=15 mmHg. High DBP: \>=100 mmHg with increase from baseline of \>=15 mmHg. Low heart rate: \<=50 beats/min with decrease from baseline of \>=15 beats/min. High heart rate: \>=120 beats/min with increase from baseline of \>=15 beats/min. Low temperature: \<=36 degree Celsius (C). High temperature: \>=37.5 degree C. Low Weight: decrease from baseline \>=20%. High weight: increase from baseline \>=10%. |
| Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR) | From date of first documented CR or PR up to disease progression or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) | DOR was defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression, or death due to any cause after achieving a response. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \< 10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. DOR was estimated using the Kaplan-Meier method. |
Countries
United States
Participant flow
Recruitment details
This study had 2 phases: Phase 1B and 2. Originally, Phase 1b of the study had Part A and B. Part A was dose escalation in participants with selected advanced solid tumors. Part B was expansion in melanoma participants. Part C was a part of Phase 2, in participants with non-small cell lung cancer (NSCLC).
Pre-assignment details
There was an amendment in protocol, which removed originally designed Part B and C, due to low enrolment. Post-implementation of this amendment 2, Part B and C were replaced with 3 cohorts in Phase 2. Study then had Part A (Phase 1b), and 3 cohorts in Phase 2. Cohorts of Phase 2 were as follows: 1) PD-1/PD-L1 inhibitor-refractory cohort, 2) pancreatic ductal adenocarcinoma cohort and 3) platinum-resistant ovarian cancer cohort.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period. | 6 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period. | 6 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period. | 7 |
| Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period. | 1 |
| Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period. | 2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period. | 19 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period. | 27 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period. | 11 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1b | Death | 4 | 6 | 5 | 1 | 0 | 0 | 0 | 0 |
| Phase 1b | Enrolled but not Treated | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 1b | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 1b | Participants terminated by Sponsor | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 1b | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Phase 2 | Death | 0 | 0 | 0 | 0 | 1 | 10 | 20 | 5 |
| Phase 2 | End of Study page not completed by error | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Phase 2 | Enrolled but not Treated | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Phase 2 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| Phase 2 | Other | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 |
| Phase 2 | Participants terminated by Sponsor | 0 | 0 | 0 | 0 | 1 | 6 | 1 | 5 |
| Phase 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 12.4 | 52.2 years STANDARD_DEVIATION 16 | 54.7 years STANDARD_DEVIATION 12.9 | 68.0 years | 47.0 years STANDARD_DEVIATION 0 | 63.1 years STANDARD_DEVIATION 12 | 65.0 years STANDARD_DEVIATION 9.6 | 59.3 years STANDARD_DEVIATION 13.1 | 61.6 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 7 Participants | 1 Participants | 2 Participants | 18 Participants | 23 Participants | 10 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 7 Participants | 1 Participants | 2 Participants | 15 Participants | 23 Participants | 9 Participants | 68 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants | 12 Participants | 12 Participants | 11 Participants | 44 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 7 Participants | 15 Participants | 0 Participants | 35 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 6 | 6 / 6 | 5 / 7 | 1 / 1 | 1 / 2 | 10 / 19 | 20 / 27 | 5 / 11 |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 6 / 7 | 1 / 1 | 2 / 2 | 19 / 19 | 26 / 27 | 10 / 11 |
| serious Total, serious adverse events | 3 / 6 | 1 / 6 | 3 / 7 | 1 / 1 | 1 / 2 | 8 / 19 | 15 / 27 | 5 / 11 |
Outcome results
Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT)
DLT: adverse event (AE) or abnormal laboratory value not clearly attributable to an extraneous cause, such as disease progression, intercurrent illness, or concomitant medications occurring during 21 days of Cycle 1, met 1 of the criteria A) nonhematologic AEs: recurring grade 2 pneumonitis, grade 3 events (irAE, QTcF prolongation, rash; other grade 3/4 except alopecia, nausea, diarrhea, vomiting, tumor flare, pseudoprogression, endocrinopathy); B) hematology AEs/laboratory abnormalities: grade 4 events except lymphopenia, neutropenia, electrolyte imbalances or abnormalities, grade 3 thrombocytopenia, febrile neutropenia, grade 4 AST/ALT elevation, grade 3 AST/ALT elevation lasting \>7 days, associated with bilirubin levels\>=2\*ULN or international normalized ratio \>1.5, grade 3 bilirubin elevation \>=3, CK elevation \>=grade 3 lasting, increase in creatinine \>=1.5\*baseline value, dose delay (dose interruption for \>14 days) or other (inability to receive at least 67% of ARRY-382 doses).
Time frame: Cycle 1 (up to 21 days)
Population: Dose-determining set (DDS) included all participants in Phase 1b who received at least 67% of the planned cumulative dose of ARRY-382 during Cycle 1 or discontinued the treatment because of DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT) | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT) | 2 Participants |
Phase 2 Cohorts: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 millimeter (mm). PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.
Time frame: From day of first dose to 30 days after last dose (maximum up to 13.5 months)
Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 Cohorts: Objective Response Rate (ORR) | 0.0 percentage of participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 Cohorts: Objective Response Rate (ORR) | 3.7 percentage of participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 Cohorts: Objective Response Rate (ORR) | 0.0 percentage of participants |
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Accumulation ratio was calculated and reported for Cmax as RCmax and for AUC as RAUC. RCmax = Cmax at steady-state on Day 1 of Cycle 2 divided by Cmax on Day 1 of Cycle 1. RAUC = AUC from zero to 8 hours after drug administration at steady-state on Day 1 of Cycle 2 divided by AUC from zero to 8 hours after drug administration on Day 1 of Cycle 1.
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration),1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one postdose blood draw to determineplasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RCmax | 3.03 ratio | Geometric Coefficient of Variation 53.4 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RAUC | 3.47 ratio | Geometric Coefficient of Variation 94.9 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RCmax | 2.72 ratio | Geometric Coefficient of Variation 54.5 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RAUC | 3.49 ratio | Geometric Coefficient of Variation 51.7 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RAUC | 4.03 ratio | Geometric Coefficient of Variation 93 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RAUC | 3.03 ratio | Geometric Coefficient of Variation 47.9 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RCmax | 2.53 ratio | Geometric Coefficient of Variation 48.2 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RCmax | 2.67 ratio | Geometric Coefficient of Variation 46.1 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RAUC | 1.97 ratio | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RCmax | 2.51 ratio | Geometric Coefficient of Variation 95.7 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RCmax | 2.60 ratio | Geometric Coefficient of Variation 157 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RCmax | 2.54 ratio | Geometric Coefficient of Variation 52 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RAUC | 4.48 ratio | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RAUC | 4.36 ratio | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RAUC | 1.92 ratio | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RCmax | 3.59 ratio | Geometric Coefficient of Variation 95.3 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RCmax | 2.50 ratio | Geometric Coefficient of Variation 65.1 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RAUC | 3.96 ratio | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RAUC | 2.73 ratio | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RAUC | 3.52 ratio | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RCmax | 2.02 ratio | Geometric Coefficient of Variation 20.1 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RCmax | 2.28 ratio | Geometric Coefficient of Variation 54.2 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RAUC | 4.28 ratio | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RCmax | 2.47 ratio | Geometric Coefficient of Variation 38.5 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RAUC | 2.64 ratio | Geometric Coefficient of Variation 36.3 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RAUC | 2.67 ratio | Geometric Coefficient of Variation 36.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RCmax | 2.39 ratio | Geometric Coefficient of Variation 48.6 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RAUC | 4.01 ratio | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RCmax | 3.19 ratio | Geometric Coefficient of Variation 36.7 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RCmax | 2.44 ratio | Geometric Coefficient of Variation 41.3 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RCmax | 2.52 ratio | Geometric Coefficient of Variation 39.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RAUC | 4.67 ratio | — |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RAUC | 3.30 ratio | Geometric Coefficient of Variation 61.9 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RCmax | 2.07 ratio | Geometric Coefficient of Variation 53.6 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RCmax | 2.08 ratio | Geometric Coefficient of Variation 49 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RAUC | 3.41 ratio | Geometric Coefficient of Variation 23.6 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RAUC | 4.95 ratio | Geometric Coefficient of Variation 41.8 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RCmax | 3.56 ratio | Geometric Coefficient of Variation 48.4 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RAUC | 3.84 ratio | Geometric Coefficient of Variation 13.5 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RCmax | 2.03 ratio | Geometric Coefficient of Variation 38.7 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RCmax | 1.76 ratio | Geometric Coefficient of Variation 29.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RAUC | 2.03 ratio | Geometric Coefficient of Variation 23.9 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RCmax | 1.93 ratio | Geometric Coefficient of Variation 37.4 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 RAUC | 2.07 ratio | Geometric Coefficient of Variation 23.8 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RAUC | 1.87 ratio | Geometric Coefficient of Variation 16.7 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 RCmax | 1.62 ratio | Geometric Coefficient of Variation 24.7 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 RCmax | 1.77 ratio | Geometric Coefficient of Variation 31 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 RAUC | 1.93 ratio | Geometric Coefficient of Variation 23 |
Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
AUCtau was defined as area under the plasma concentration-time curve over the dosing interval, where dosing interval was 24 hours.
Time frame: 0 to 24 hrs after administration of ARRY-382 on Day 1 of Cycle 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 2170 hour*nanogram per milliliter | Geometric Coefficient of Variation 85.9 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 3180 hour*nanogram per milliliter | Geometric Coefficient of Variation 59 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 4150 hour*nanogram per milliliter | Geometric Coefficient of Variation 63.5 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 22800 hour*nanogram per milliliter | Geometric Coefficient of Variation 44.2 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 30600 hour*nanogram per milliliter | Geometric Coefficient of Variation 26.6 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 3860 hour*nanogram per milliliter | Geometric Coefficient of Variation 33.9 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 9810 hour*nanogram per milliliter | Geometric Coefficient of Variation 29.3 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 4530 hour*nanogram per milliliter | Geometric Coefficient of Variation 106 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 30800 hour*nanogram per milliliter | Geometric Coefficient of Variation 130 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 5880 hour*nanogram per milliliter | Geometric Coefficient of Variation 78.8 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 6200 hour*nanogram per milliliter | Geometric Coefficient of Variation 45.2 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 3510 hour*nanogram per milliliter | Geometric Coefficient of Variation 142 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 2670 hour*nanogram per milliliter | Geometric Coefficient of Variation 53.4 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 7920 hour*nanogram per milliliter | Geometric Coefficient of Variation 18.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 6850 hour*nanogram per milliliter | Geometric Coefficient of Variation 61.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 32100 hour*nanogram per milliliter | Geometric Coefficient of Variation 65.7 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 5360 hour*nanogram per milliliter | Geometric Coefficient of Variation 62.8 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 47100 hour*nanogram per milliliter | Geometric Coefficient of Variation 10.2 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 7940 hour*nanogram per milliliter | Geometric Coefficient of Variation 36.9 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 14200 hour*nanogram per milliliter | Geometric Coefficient of Variation 123 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 2840 hour*nanogram per milliliter | Geometric Coefficient of Variation 61.8 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 2480 hour*nanogram per milliliter | Geometric Coefficient of Variation 73.9 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 8220 hour*nanogram per milliliter | Geometric Coefficient of Variation 20.3 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 20700 hour*nanogram per milliliter | Geometric Coefficient of Variation 70.6 |
Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Measured concentration at the pre-dose at steady-state.
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration) on Day 1 of Cycle 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 60.1 nanogram per milliliter | Geometric Coefficient of Variation 103 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 136 nanogram per milliliter | Geometric Coefficient of Variation 67.7 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 576 nanogram per milliliter | Geometric Coefficient of Variation 59.5 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 99.1 nanogram per milliliter | Geometric Coefficient of Variation 80.8 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 146 nanogram per milliliter | Geometric Coefficient of Variation 105 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 96.0 nanogram per milliliter | Geometric Coefficient of Variation 43.9 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 313 nanogram per milliliter | Geometric Coefficient of Variation 41.7 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 667 nanogram per milliliter | Geometric Coefficient of Variation 27.7 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 161 nanogram per milliliter | Geometric Coefficient of Variation 105 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 627 nanogram per milliliter | Geometric Coefficient of Variation 126 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 83.6 nanogram per milliliter | Geometric Coefficient of Variation 137 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 185 nanogram per milliliter | Geometric Coefficient of Variation 27.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 82.4 nanogram per milliliter | Geometric Coefficient of Variation 57.1 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 878 nanogram per milliliter | Geometric Coefficient of Variation 70.1 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 277 nanogram per milliliter | Geometric Coefficient of Variation 27.1 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 232 nanogram per milliliter | Geometric Coefficient of Variation 58.5 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 1480 nanogram per milliliter | Geometric Coefficient of Variation 17.5 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 557 nanogram per milliliter | Geometric Coefficient of Variation 136 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 193 nanogram per milliliter | Geometric Coefficient of Variation 71.3 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 302 nanogram per milliliter | Geometric Coefficient of Variation 48.1 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469099 | 77.1 nanogram per milliliter | Geometric Coefficient of Variation 85.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | ARRY-382 | 438 nanogram per milliliter | Geometric Coefficient of Variation 86.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00470870 | 224 nanogram per milliliter | Geometric Coefficient of Variation 34.1 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | AR00469100 | 57.1 nanogram per milliliter | Geometric Coefficient of Variation 99.2 |
Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR)
DOR was defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression, or death due to any cause after achieving a response. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \< 10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. DOR was estimated using the Kaplan-Meier method.
Time frame: From date of first documented CR or PR up to disease progression or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. This outcome measure was evaluated in participants who achieved an objective response. Overall Number of participants Analyzed =0, signifies participants did not had documented CR or PR for respective reporting arms.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR) | 29.2 months |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR) | 3.1 months |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR) | 2.4 months |
Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)
irPFS was defined as the time from the start of treatment to the time of first documented progression per irRC, or death due to any cause. irRC criteria for progression for 1) Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%); 2) New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. For the analysis of irPFS, Kaplan-Meier method was used.
Time frame: From the start of treatment to the time of first documented progression, or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS) | 3.0 months |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS) | 2.5 months |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS) | 1.3 months |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS) | 1.5 months |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS) | 1.3 months |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS) | 2.5 months |
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Cmax was obtained from plasma concentration time curve. Cmax at single dose was reported at Cycle1 Day 1 and Cmax at steady state was reported at Cycle 2 Day 1.
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here Number Analyzed signifies number of participants evaluated for given time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 61.2 nanogram per milliliter | Geometric Coefficient of Variation 78.3 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 84.0 nanogram per milliliter | Geometric Coefficient of Variation 102 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 138 nanogram per milliliter | Geometric Coefficient of Variation 81.6 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 212 nanogram per milliliter | Geometric Coefficient of Variation 57.3 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 773 nanogram per milliliter | Geometric Coefficient of Variation 60.2 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 172 nanogram per milliliter | Geometric Coefficient of Variation 51.6 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 1560 nanogram per milliliter | Geometric Coefficient of Variation 41.3 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 70.1 nanogram per milliliter | Geometric Coefficient of Variation 95.1 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 2260 nanogram per milliliter | Geometric Coefficient of Variation 36.6 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 534 nanogram per milliliter | Geometric Coefficient of Variation 22 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 995 nanogram per milliliter | Geometric Coefficient of Variation 68.9 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 104 nanogram per milliliter | Geometric Coefficient of Variation 86.5 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 100 nanogram per milliliter | Geometric Coefficient of Variation 59.8 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 241 nanogram per milliliter | Geometric Coefficient of Variation 103 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 174 nanogram per milliliter | Geometric Coefficient of Variation 92.5 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 257 nanogram per milliliter | Geometric Coefficient of Variation 36.4 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 219 nanogram per milliliter | Geometric Coefficient of Variation 83.8 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 122 nanogram per milliliter | Geometric Coefficient of Variation 41.7 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 333 nanogram per milliliter | Geometric Coefficient of Variation 60.7 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 2560 nanogram per milliliter | Geometric Coefficient of Variation 117 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 1330 nanogram per milliliter | Geometric Coefficient of Variation 39.6 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 328 nanogram per milliliter | Geometric Coefficient of Variation 75.6 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 196 nanogram per milliliter | Geometric Coefficient of Variation 58.5 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 268 nanogram per milliliter | Geometric Coefficient of Variation 141 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 119 nanogram per milliliter | Geometric Coefficient of Variation 50.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 2130 nanogram per milliliter | Geometric Coefficient of Variation 60.4 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 328 nanogram per milliliter | Geometric Coefficient of Variation 44 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 132 nanogram per milliliter | Geometric Coefficient of Variation 70 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 181 nanogram per milliliter | Geometric Coefficient of Variation 56.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 193 nanogram per milliliter | Geometric Coefficient of Variation 60.5 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 1240 nanogram per milliliter | Geometric Coefficient of Variation 62.1 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 373 nanogram per milliliter | Geometric Coefficient of Variation 60.6 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 147 nanogram per milliliter | Geometric Coefficient of Variation 98.9 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 363 nanogram per milliliter | Geometric Coefficient of Variation 30.9 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 116 nanogram per milliliter | Geometric Coefficient of Variation 98.3 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 646 nanogram per milliliter | Geometric Coefficient of Variation 111 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 142 nanogram per milliliter | Geometric Coefficient of Variation 97.9 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 2820 nanogram per milliliter | Geometric Coefficient of Variation 15.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 279 nanogram per milliliter | Geometric Coefficient of Variation 54.9 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 1290 nanogram per milliliter | Geometric Coefficient of Variation 75.6 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 486 nanogram per milliliter | Geometric Coefficient of Variation 18.9 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 231 nanogram per milliliter | Geometric Coefficient of Variation 50.8 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 215 nanogram per milliliter | Geometric Coefficient of Variation 52.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 1260 nanogram per milliliter | Geometric Coefficient of Variation 53.9 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 95.4 nanogram per milliliter | Geometric Coefficient of Variation 43.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 138 nanogram per milliliter | Geometric Coefficient of Variation 46.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 161 nanogram per milliliter | Geometric Coefficient of Variation 50.8 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 1580 nanogram per milliliter | Geometric Coefficient of Variation 64.8 |
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Different MR reported for single dose calculated at Cycle 1 Day 1 were as follows: 1) MRAUClast = ratio of AUClast values of the metabolite compared to parent, corrected for molecular weight, where AUClast was area under the plasma concentration-time curve from zero to the last measurable time point; 2) MRCmax = ratio of Cmax values of the metabolite compared to parent, corrected for molecular weight. Different MR reported for steady state calculated at Cycle 2 Day 1 were as follows: 1) MRAUCtau,ss = ratio of AUCtau,ss values of the metabolite compared to parent, corrected for molecular weight, where AUCtau was area under the plasma concentration-time curve over a dosing interval at steady-state; 2) MRCmax,ss = Ratio of Cmax,ss values of the metabolite compared to parent, corrected for molecular weight.
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration),1 hrs (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here Number Analyzed signifies number of participants evaluated for given time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRAUCtau,ss | 0.0978 ratio | Geometric Coefficient of Variation 43.8 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRAUClast | 0.0817 ratio | Geometric Coefficient of Variation 40.7 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRCmax | 0.0811 ratio | Geometric Coefficient of Variation 45 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRCmax,ss | 0.0909 ratio | Geometric Coefficient of Variation 41.4 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRCmax | 0.0775 ratio | Geometric Coefficient of Variation 119 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRCmax,ss | 0.0941 ratio | Geometric Coefficient of Variation 84.4 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRAUClast | 0.115 ratio | Geometric Coefficient of Variation 86.8 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRAUClast | 0.0946 ratio | Geometric Coefficient of Variation 104 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRCmax | 0.106 ratio | Geometric Coefficient of Variation 58.8 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRAUCtau,ss | 0.119 ratio | Geometric Coefficient of Variation 80.2 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRAUCtau,ss | 0.177 ratio | Geometric Coefficient of Variation 35.6 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRCmax,ss | 0.132 ratio | Geometric Coefficient of Variation 20.5 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRCmax,ss | 0.116 ratio | Geometric Coefficient of Variation 29.3 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRCmax,ss | 0.201 ratio | Geometric Coefficient of Variation 36.1 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRAUClast | 0.159 ratio | Geometric Coefficient of Variation 42.7 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRAUCtau,ss | 0.144 ratio | Geometric Coefficient of Variation 80.3 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRAUClast | 0.101 ratio | Geometric Coefficient of Variation 47.9 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRAUCtau,ss | 0.129 ratio | Geometric Coefficient of Variation 27.1 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRCmax | 0.107 ratio | Geometric Coefficient of Variation 35 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRCmax | 0.0979 ratio | Geometric Coefficient of Variation 74.9 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRAUClast | 0.101 ratio | Geometric Coefficient of Variation 33.4 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRAUCtau,ss | 0.273 ratio | Geometric Coefficient of Variation 43.1 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRCmax | 0.149 ratio | Geometric Coefficient of Variation 26.6 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRCmax,ss | 0.103 ratio | Geometric Coefficient of Variation 68.2 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRAUClast | 0.0934 ratio | Geometric Coefficient of Variation 31 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRCmax | 0.0941 ratio | Geometric Coefficient of Variation 21.8 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRCmax,ss | 0.111 ratio | Geometric Coefficient of Variation 42.7 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRAUCtau,ss | 0.186 ratio | Geometric Coefficient of Variation 84.6 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRAUClast | 0.127 ratio | Geometric Coefficient of Variation 44.9 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRCmax,ss | 0.125 ratio | Geometric Coefficient of Variation 74.8 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRCmax | 0.160 ratio | Geometric Coefficient of Variation 79.5 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRAUCtau,ss | 0.172 ratio | Geometric Coefficient of Variation 66.7 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRAUClast | 0.151 ratio | Geometric Coefficient of Variation 70.9 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRCmax | 0.126 ratio | Geometric Coefficient of Variation 30.4 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRAUCtau,ss | 0.117 ratio | Geometric Coefficient of Variation 13.1 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRCmax,ss | 0.108 ratio | Geometric Coefficient of Variation 24.5 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRCmax,ss | 0.150 ratio | Geometric Coefficient of Variation 89.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRAUCtau,ss | 0.240 ratio | Geometric Coefficient of Variation 69 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRCmax | 0.133 ratio | Geometric Coefficient of Variation 78 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRAUCtau,ss | 0.182 ratio | Geometric Coefficient of Variation 69.3 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRCmax,ss | 0.150 ratio | Geometric Coefficient of Variation 66.6 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRAUClast | 0.101 ratio | Geometric Coefficient of Variation 45.7 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRCmax | 0.0929 ratio | Geometric Coefficient of Variation 46.5 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRAUClast | 0.104 ratio | Geometric Coefficient of Variation 39.3 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRCmax | 0.109 ratio | Geometric Coefficient of Variation 47.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRAUCtau,ss | 0.0853 ratio | Geometric Coefficient of Variation 13.8 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRCmax,ss | 0.0873 ratio | Geometric Coefficient of Variation 19.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRAUClast | 0.151 ratio | Geometric Coefficient of Variation 71.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRCmax,ss | 0.222 ratio | Geometric Coefficient of Variation 108 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRCmax | 0.0923 ratio | Geometric Coefficient of Variation 41.3 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRCmax | 0.107 ratio | Geometric Coefficient of Variation 71.8 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRAUCtau,ss | 0.292 ratio | Geometric Coefficient of Variation 132 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRAUCtau,ss | 0.144 ratio | Geometric Coefficient of Variation 41.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRAUCtau,ss | 0.117 ratio | Geometric Coefficient of Variation 66.4 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRCmax,ss | 0.101 ratio | Geometric Coefficient of Variation 52.8 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRAUClast | 0.108 ratio | Geometric Coefficient of Variation 63.4 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRCmax,ss | 0.110 ratio | Geometric Coefficient of Variation 31.3 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRCmax | 0.0974 ratio | Geometric Coefficient of Variation 51.4 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRAUClast | 0.106 ratio | Geometric Coefficient of Variation 64 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRAUClast | 0.0883 ratio | Geometric Coefficient of Variation 41.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRCmax,ss | 0.0991 ratio | Geometric Coefficient of Variation 24 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRCmax,ss | 0.140 ratio | Geometric Coefficient of Variation 44.3 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRCmax | 0.112 ratio | Geometric Coefficient of Variation 29.8 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRAUClast | 0.176 ratio | Geometric Coefficient of Variation 72.4 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 MRAUCtau,ss | 0.134 ratio | Geometric Coefficient of Variation 27.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRCmax,ss | 0.263 ratio | Geometric Coefficient of Variation 59.6 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 MRAUClast | 0.108 ratio | Geometric Coefficient of Variation 22.9 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 MRAUCtau,ss | 0.340 ratio | Geometric Coefficient of Variation 59 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 MRAUCtau,ss | 0.123 ratio | Geometric Coefficient of Variation 40.8 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRCmax | 0.0734 ratio | Geometric Coefficient of Variation 38.3 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 MRAUClast | 0.0821 ratio | Geometric Coefficient of Variation 31.3 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 MRCmax | 0.156 ratio | Geometric Coefficient of Variation 71.6 |
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding
Urinalysis laboratory parameters/abnormalities: Decimal logarithm of reciprocal of hydrogen ion activity (pH), specific gravity, protein, glucose, ketones, nitrite, blood, leukocyte esterase, microscopy (if urine tested positive for blood or protein). Clinical significance was judged by investigator.
Time frame: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding | 0 Participants |
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests
Liver function parameters/abnormalities: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): \>3\* upper limit of normal (ULN), \>5\*ULN, \>8\*ULN, \>10\*ULN, \>20\*ULN; Bilirubin \>1.5\*ULN, \>2\*ULN; Alkaline phosphatase (ALP) \>2\*ULN, \>3\*ULN.
Time frame: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >5*ULN | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >20*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALP >3*ULN and Total Bilirubin >2*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >3*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >8*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >3*ULN | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >10*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >2*ULN | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >20*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >10*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >20*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >2*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >3*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >3*ULN | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >10*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >8*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >5*ULN | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >5*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >3*ULN | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >10*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >8*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >1.5*ULN | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >5*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >3*ULN | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >5*ULN | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >5*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >20*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >20*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >8*ULN | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >10*ULN | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALP >3*ULN and Total Bilirubin >2*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >10*ULN | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >8*ULN | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >3*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >5*ULN | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >20*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >3*ULN | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >8*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >2*ULN | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >10*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >2*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >3*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >1.5*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >3*ULN | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >10*ULN | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >5*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALP >3*ULN and Total Bilirubin >2*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >5*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >10*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >10*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >20*ULN | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >2*ULN | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >3*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >3*ULN | 4 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >5*ULN | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >5*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >8*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >10*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >20*ULN | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >1.5*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >2*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >3*ULN | 4 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >5*ULN | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >8*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >8*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >10*ULN | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >20*ULN | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >3*ULN | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >3*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >3*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >10*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >10*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >8*ULN | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >20*ULN | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >8*ULN | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >20*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALP >3*ULN and Total Bilirubin >2*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >5*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >10*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >3*ULN | 7 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >5*ULN | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >2*ULN | 5 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >8*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >1.5*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >10*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >3*ULN | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >2*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >3*ULN | 7 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >5*ULN | 4 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >5*ULN | 4 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >20*ULN | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >3*ULN | 4 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >20*ULN | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >3*ULN | 9 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >1.5*ULN | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >2*ULN | 12 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >3*ULN | 4 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >2*ULN | 4 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >3*ULN | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >20*ULN | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >3*ULN | 13 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >10*ULN | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >20*ULN | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >5*ULN | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >5*ULN | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >8*ULN | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALP >3*ULN and Total Bilirubin >2*ULN | 3 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >10*ULN | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >8*ULN | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >8*ULN | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >10*ULN | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >5*ULN | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >5*ULN | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >10*ULN | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >3*ULN | 13 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >3*ULN | 5 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >3*ULN | 4 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >5*ULN | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >8*ULN | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >10*ULN | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alanine Aminotransferase: >20*ULN | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >2*ULN | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Alkaline Phosphatase: >3*ULN | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >3*ULN | 5 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >5*ULN | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >8*ULN | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >10*ULN | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Aspartate Aminotransferase: >20*ULN | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >1.5*ULN | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | Bilirubin: >2*ULN | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >5*ULN | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >8*ULN | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >10*ULN | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST: AT >20*ULN | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >3*ULN | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >5*ULN | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST and Total Bilirubin >2*ULN: AT >10*ULN | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALP >3*ULN and Total Bilirubin >2*ULN | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests | ALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN | 0 Participants |
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, body temperature and weight. Low SBP: less than or equal to (\<=)90 millimeter of mercury (mmHg) with decrease from baseline of \>=20 mmHg. High SBP: \>=160 mmHg with increase from baseline of \>=20 mmHg. Low DBP: \<=50 mmHg with decrease from baseline of \>=15 mmHg. High DBP: \>=100 mmHg with increase from baseline of \>=15 mmHg. Low heart rate: \<=50 beats/min with decrease from baseline of \>=15 beats/min. High heart rate: \>=120 beats/min with increase from baseline of \>=15 beats/min. Low temperature: \<=36 degree Celsius (C). High temperature: \>=37.5 degree C. Low Weight: decrease from baseline \>=20%. High weight: increase from baseline \>=10%.
Time frame: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: High | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: Low | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: High | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: Low | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: High | 3 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: Low | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: Low | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: High | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: High | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: Low | 4 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: Low | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: Low | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: High | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: High | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: High | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: Low | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: Low | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: Low | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: High | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: High | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: Low | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: High | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: High | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: Low | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: High | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: Low | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: High | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: Low | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: High | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: Low | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: High | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: Low | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: High | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: Low | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: High | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: Low | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: High | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: Low | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: Low | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: High | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: High | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: Low | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: High | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: Low | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: Low | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: Low | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: High | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: High | 3 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: High | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: Low | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: Low | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: Low | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: High | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Temperature: High | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: Low | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: Low | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Weight: High | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | SBP: High | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | Heart Rate: High | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities | DBP: Low | 0 Participants |
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03
Hematology abnormalities: Hemoglobin (anemia/hemoglobin increased), Platelets (count decreased), Leukocytes (count decreased/increased), Neutrophils (count decreased), Lymphocytes (count increased/decreased). Coagulation abnormalities: International Normalized Ratio (INR increased), Partial thromboplastin time(PTT)/Activated partial thromboplastin Time (aPTT, time prolonged). Abnormalities were graded by CTCAE grade 4.03 as Grade 1= mild; Grade 2 = moderate; Grade 3/Grade 4 = severe/life-threatening. Participants with all grades and grade 3/4 abnormalities were reported.
Time frame: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: All Grades | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: Grade 3/4 | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: All Grades | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: All Grades | 3 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: All Grades | 4 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: All Grades | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: All Grades | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: All Grades | 5 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: Grade 3/4 | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: All Grades | 3 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: All Grades | 3 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: All Grades | 4 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: All Grades | 12 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: Grade 3/4 | 4 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: All Grades | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: All Grades | 11 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: Grade 3/4 | 5 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: All Grades | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: All Grades | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: All Grades | 6 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades | 9 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: All Grades | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: Grade 3/4 | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: All Grades | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: All Grades | 9 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: All Grades | 7 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: All Grades | 11 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: All Grades | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4 | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades | 15 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: All Grades | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: All Grades | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: Grade 3/4 | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: All Grades | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: All Grades | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: All Grades | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Neutrophils (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hyper: All Grades | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Platelets (10^9/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hypo: All Grades | 7 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: Grade 3/4 | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Hemoglobin (g/L), Hyper: All Grades | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Lymphocytes (10^9/L), Hypo: All Grades | 5 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 | Leukocytes (10^9/L), Hypo: All Grades | 2 Participants |
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03
Abnormalities: Albumin (hypoalbuminemia),Alkaline phosphatase (ALP increased), Alanine aminotransferase (ALT increased), Aspartate aminotransferase (AST increased),Total bilirubin (TBL increased), Creatinine (increased), Corrected calcium (hypocalcemia/hypercalcemia), Creatine kinase (CK increased), Glucose (hypoglycemia/hyperglycemia), Amylase (increased), Lipase (increased) ,Phosphate (hypophosphatemia), Magnesium (hypomagnesemia/hypermagnesemia), Potassium (hypokalemia/hyperkalemia), Sodium (hyponatremia/hypernatremia). Participants with all grades and grade 3/4 abnormalities were reported. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening.
Time frame: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: All Grades | 3 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (g/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: All Grades | 3 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: All Grades | 5 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (millimoles per liter [mmol/L]), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (grams per liter [g/L]), Hypo: All Grades | 4 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (umol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: All Grades | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: All Grades | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: All Grades | 5 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: All Grades | 5 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (U/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: All Grades | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades | 5 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: All Grades | 3 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: All Grades | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: All Grades | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: All Grades | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: All Grades | 4 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (grams per liter [g/L]), Hypo: All Grades | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: All Grades | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: All Grades | 6 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (umol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (millimoles per liter [mmol/L]), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (g/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: All Grades | 4 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: All Grades | 5 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (millimoles per liter [mmol/L]), Hypo: All Grades | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: All Grades | 4 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: All Grades | 3 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (g/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades | 4 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (grams per liter [g/L]), Hypo: All Grades | 4 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: All Grades | 3 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: All Grades | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: All Grades | 6 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: All Grades | 5 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: All Grades | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: All Grades | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: All Grades | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: All Grades | 3 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (umol/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: All Grades | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: All Grades | 6 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: All Grades | 8 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (grams per liter [g/L]), Hypo: All Grades | 5 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (g/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades | 11 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: All Grades | 8 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: All Grades | 11 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: Grade 3/4 | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: All Grades | 17 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: Grade 3/4 | 4 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (umol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (millimoles per liter [mmol/L]), Hypo: All Grades | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: All Grades | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: All Grades | 16 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: Grade 3/4 | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: All Grades | 7 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: All Grades | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: All Grades | 7 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: Grade 3/4 | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: All Grades | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: Grade 3/4 | 7 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: All Grades | 5 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: All Grades | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: Grade 3/4 | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: All Grades | 8 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: All Grades | 4 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades | 17 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: Grade 3/4 | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (g/L), Hypo: Grade 3/4 | 3 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: All Grades | 23 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: All Grades | 6 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: All Grades | 7 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: All Grades | 20 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: All Grades | 7 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: All Grades | 4 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: Grade 3/4 | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (millimoles per liter [mmol/L]), Hypo: All Grades | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: All Grades | 12 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: All Grades | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (grams per liter [g/L]), Hypo: All Grades | 10 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: All Grades | 13 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (umol/L), Hyper: Grade 3/4 | 3 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (U/L), Hyper: Grade 3/4 | 4 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades | 7 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: All Grades | 6 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: All Grades | 4 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: All Grades | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: All Grades | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: All Grades | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: Grade 3/4 | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: All Grades | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: Grade 3/4 | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: All Grades | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatine Kinase (U/L), Hyper: All Grades | 7 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: All Grades | 5 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (g/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Lipase (U/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Calcium (millimoles per liter [mmol/L]), Hypo: All Grades | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: All Grades | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (umol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: All Grades | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Aspartate Aminotransferase (U/L), Hyper: All Grades | 11 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Magnesium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: Grade 3/4 | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Amylase (U/L), Hyper: All Grades | 7 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: All Grades | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: Grade 3/4 | 3 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Albumin (grams per liter [g/L]), Hypo: All Grades | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Phosphate (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alanine Aminotransferase (U/L), Hyper: All Grades | 7 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (U/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hypo: All Grades | 6 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: All Grades | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades | 6 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hyper: Grade 3/4 | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Sodium (mmol/L), Hyper: Grade 3/4 | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Potassium (mmol/L), Hypo: All Grades | 4 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Glucose (mmol/L), Hypo: All Grades | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 | Creatinine (umol/L), Hyper: Grade 3/4 | 0 Participants |
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades
Thyroid panel laboratory parameters/abnormalities: thyrotropin, free triiodothyronine (T3), free thyroxine (T4). Shift in thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing is reported in this outcome measure.
Time frame: Baseline, 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Normal (at post baseline) | 4 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Low (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: High (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Normal (at post baseline) | 6 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Normal (at post baseline) | 5 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline) | 12 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Low (at post baseline) | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to High (at post baseline) | 4 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Low (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Normal (at post baseline) | 14 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Normal (at post baseline) | 12 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Normal (at post baseline) | 12 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to High (at post baseline) | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Normal (at post baseline) | 18 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Missing (at post baseline) | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline) | 4 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to High (at post baseline) | 5 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Low (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Low (at post baseline) | 3 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline) | 12 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Low (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline) | 3 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Missing (at post baseline) | 4 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Normal (at post baseline) | 5 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Normal (at post baseline) | 8 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline) | 7 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to High (at post baseline) | 5 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Low (at post baseline) | 4 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyroxine, Free: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades | Thyrotropin: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 Participants |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 Participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 Participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 19 Participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 8 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 27 Participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 15 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 10 Participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 Participants |
Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)
OS was defined as the time from the start of treatment to the date of death due to any cause. If a death was not observed by the date of the analysis cut-off, OS was censored at the date of last contact. OS was estimated using the Kaplan-Meier method.
Time frame: From day of first dose till death due to any cause or date of last contact (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS) | 14.7 months |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS) | 7.4 months |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS) | 6.5 months |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS) | 12.4 months |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS) | 2.2 months |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS) | NA months |
Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR)
irRR was defined as the percentage of participants who achieved immune-related best overall response (irBOR) of immune-related CR (irCR) or immune-related PR (irPR), as determined by the investigator per immune related response criteria (irRC). irBOR was the best response using irRC recorded from the start of study treatment until the end of treatment. irCR was the disappearance of all target lesions, irPR was a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.
Time frame: From day of first dose till up to end of study treatment (for Phase 1b: maximum up to 33.7 months, for Phase 2: maximum up to 12.5 months)
Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR) | 16.7 percentage of participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR) | 16.7 percentage of participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR) | 0.0 percentage of participants |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR) | 0.0 percentage of participants |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR) | 3.7 percentage of participants |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR) | 0.0 percentage of participants |
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382
The lower limit of quantitation (LLOQ) for analyte ARRY-382 was 5.00 nanogram per milliliter (ng/mL).
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hour(hr) (±5 min), 2 hours(hrs) (±10 min), 4 hrs (±20 min) and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Population: Pharmacokinetic (PK) set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382. Here Number Analyzed signifies number of participants evaluated for given time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 542 nanogram per milliliter | Geometric Coefficient of Variation 78.8 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 1170 nanogram per milliliter | Geometric Coefficient of Variation 76.5 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 4 Day 1 / Pre ARRY-382 dose | 405 nanogram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 1200 nanogram per milliliter | Geometric Coefficient of Variation 57.6 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 5 Day 1 / Pre ARRY-382 dose | NA nanogram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 384 nanogram per milliliter | Geometric Coefficient of Variation 26.3 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 1530 nanogram per milliliter | Geometric Coefficient of Variation 45.2 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 283 nanogram per milliliter | Geometric Coefficient of Variation 422 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / Pre ARRY-382 dose | 576 nanogram per milliliter | Geometric Coefficient of Variation 59.5 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 3 Day 1 / Pre ARRY-382 dose | 565 nanogram per milliliter | Geometric Coefficient of Variation 39.5 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 15 / Pre ARRY-382 dose | 616 nanogram per milliliter | Geometric Coefficient of Variation 43 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 1100 nanogram per milliliter | Geometric Coefficient of Variation 35.7 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 530 nanogram per milliliter | Geometric Coefficient of Variation 37.9 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 1310 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 1680 nanogram per milliliter | Geometric Coefficient of Variation 8.22 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 3 Day 1 / Pre ARRY-382 dose | 305 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 497 nanogram per milliliter | Geometric Coefficient of Variation 201 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 2030 nanogram per milliliter | Geometric Coefficient of Variation 35.1 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 845 nanogram per milliliter | Geometric Coefficient of Variation 49 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 49.7 nanogram per milliliter | Geometric Coefficient of Variation 1130 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 566 nanogram per milliliter | Geometric Coefficient of Variation 28.8 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 15 / Pre ARRY-382 dose | 533 nanogram per milliliter | Geometric Coefficient of Variation 34.2 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / Pre ARRY-382 dose | 762 nanogram per milliliter | Geometric Coefficient of Variation 6.44 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 1600 nanogram per milliliter | Geometric Coefficient of Variation 106 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 2120 nanogram per milliliter | Geometric Coefficient of Variation 126 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 1440 nanogram per milliliter | Geometric Coefficient of Variation 142 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 15 / Pre ARRY-382 dose | 888 nanogram per milliliter | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 305 nanogram per milliliter | Geometric Coefficient of Variation 263 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 2560 nanogram per milliliter | Geometric Coefficient of Variation 117 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 1430 nanogram per milliliter | Geometric Coefficient of Variation 195 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 827 nanogram per milliliter | Geometric Coefficient of Variation 64.2 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 757 nanogram per milliliter | Geometric Coefficient of Variation 46.8 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 1130 nanogram per milliliter | Geometric Coefficient of Variation 50 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / Pre ARRY-382 dose | 1040 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 9 Day 1 / Pre ARRY-382 dose | 350 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 664 nanogram per milliliter | Geometric Coefficient of Variation 194 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 1060 nanogram per milliliter | Geometric Coefficient of Variation 65.8 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 1010 nanogram per milliliter | Geometric Coefficient of Variation 44.7 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 683 nanogram per milliliter | Geometric Coefficient of Variation 43.7 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 15 / Pre ARRY-382 dose | 862 nanogram per milliliter | Geometric Coefficient of Variation 57.3 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 3 Day 1 / Pre ARRY-382 dose | 554 nanogram per milliliter | Geometric Coefficient of Variation 70.3 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 4 Day 1 / Pre ARRY-382 dose | 1080 nanogram per milliliter | Geometric Coefficient of Variation 119 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 6 Day 1 / Pre ARRY-382 dose | 798 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 10 Day 1 / Pre ARRY-382 dose | 244 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / Pre ARRY-382 dose | 330 nanogram per milliliter | Geometric Coefficient of Variation 2050 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 1320 nanogram per milliliter | Geometric Coefficient of Variation 97.5 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 1830 nanogram per milliliter | Geometric Coefficient of Variation 92.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 1630 nanogram per milliliter | Geometric Coefficient of Variation 66.6 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 1530 nanogram per milliliter | Geometric Coefficient of Variation 52.3 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 5 Day 1 / Pre ARRY-382 dose | 92.6 nanogram per milliliter | Geometric Coefficient of Variation 13300 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 7 Day 1 / Pre ARRY-382 dose | 573 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 8 Day 1 / Pre ARRY-382 dose | 424 nanogram per milliliter | — |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 982 nanogram per milliliter | Geometric Coefficient of Variation 101 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 5 Day 1 / Pre ARRY-382 dose | 1000 nanogram per milliliter | Geometric Coefficient of Variation 35.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 2900 nanogram per milliliter | Geometric Coefficient of Variation 4.73 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 3 Day 1 / Pre ARRY-382 dose | 324 nanogram per milliliter | Geometric Coefficient of Variation 391 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 373 nanogram per milliliter | Geometric Coefficient of Variation 282 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 4 Day 1 / Pre ARRY-382 dose | 728 nanogram per milliliter | Geometric Coefficient of Variation 85.2 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 2000 nanogram per milliliter | Geometric Coefficient of Variation 14.3 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 662 nanogram per milliliter | Geometric Coefficient of Variation 76.7 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 3000 nanogram per milliliter | Geometric Coefficient of Variation 9.01 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 2150 nanogram per milliliter | Geometric Coefficient of Variation 7.22 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 6 Day 1 / Pre ARRY-382 dose | 1100 nanogram per milliliter | — |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / Pre ARRY-382 dose | 1550 nanogram per milliliter | Geometric Coefficient of Variation 18.8 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 976 nanogram per milliliter | Geometric Coefficient of Variation 72.6 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 15 / Pre ARRY-382 dose | 918 nanogram per milliliter | Geometric Coefficient of Variation 79.1 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 1220 nanogram per milliliter | Geometric Coefficient of Variation 64.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 15 / Pre ARRY-382 dose | 485 nanogram per milliliter | Geometric Coefficient of Variation 117 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 500 nanogram per milliliter | Geometric Coefficient of Variation 52.6 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 695 nanogram per milliliter | Geometric Coefficient of Variation 145 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / Pre ARRY-382 dose | 438 nanogram per milliliter | Geometric Coefficient of Variation 86.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 937 nanogram per milliliter | Geometric Coefficient of Variation 54.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 3 Day 1 / Pre ARRY-382 dose | 336 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 7 Day 1 / Pre ARRY-382 dose | 505 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 1580 nanogram per milliliter | Geometric Coefficient of Variation 79.6 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 1160 nanogram per milliliter | Geometric Coefficient of Variation 57.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 4 Day 1 / Pre ARRY-382 dose | 522 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 1450 nanogram per milliliter | Geometric Coefficient of Variation 62.7 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 5 Day 1 / Pre ARRY-382 dose | 76.6 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 6 Day 1 / Pre ARRY-382 dose | 518 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 973 nanogram per milliliter | Geometric Coefficient of Variation 75.5 |
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469099 was reported in this outcome measure. The LLOQ for analyte AR00469099 was 1.00 ng/mL.
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00469099. Here Number Analyzed signifies number of participants evaluated for given time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 74.9 nanogram per milliliter | Geometric Coefficient of Variation 85.3 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 133 nanogram per milliliter | Geometric Coefficient of Variation 72 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 10.6 nanogram per milliliter | Geometric Coefficient of Variation 750 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 5 Day 1 / Pre ARRY-382 dose | NA nanogram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 210 nanogram per milliliter | Geometric Coefficient of Variation 57.5 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 15 / Pre ARRY-382 dose | 136 nanogram per milliliter | Geometric Coefficient of Variation 30.8 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 177 nanogram per milliliter | Geometric Coefficient of Variation 89.6 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 3 Day 1 / Pre ARRY-382 dose | 121 nanogram per milliliter | Geometric Coefficient of Variation 81.8 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 36.3 nanogram per milliliter | Geometric Coefficient of Variation 219 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 166 nanogram per milliliter | Geometric Coefficient of Variation 66 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / Pre ARRY-382 dose | 136 nanogram per milliliter | Geometric Coefficient of Variation 67.7 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 69.5 nanogram per milliliter | Geometric Coefficient of Variation 128 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 4 Day 1 / Pre ARRY-382 dose | 79.9 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 15 / Pre ARRY-382 dose | 73.7 nanogram per milliliter | Geometric Coefficient of Variation 62.1 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 96.4 nanogram per milliliter | Geometric Coefficient of Variation 62.9 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 83.6 nanogram per milliliter | Geometric Coefficient of Variation 69.2 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 3 Day 1 / Pre ARRY-382 dose | 31.0 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / Pre ARRY-382 dose | 199 nanogram per milliliter | Geometric Coefficient of Variation 82.5 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | NA nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 320 nanogram per milliliter | Geometric Coefficient of Variation 71.9 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 245 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 208 nanogram per milliliter | Geometric Coefficient of Variation 129 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 166 nanogram per milliliter | Geometric Coefficient of Variation 133 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 19.6 nanogram per milliliter | Geometric Coefficient of Variation 495 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 170 nanogram per milliliter | Geometric Coefficient of Variation 72.6 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / Pre ARRY-382 dose | 188 nanogram per milliliter | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 177 nanogram per milliliter | Geometric Coefficient of Variation 94.7 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 8.57 nanogram per milliliter | Geometric Coefficient of Variation 404 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 57.2 nanogram per milliliter | Geometric Coefficient of Variation 151 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 205 nanogram per milliliter | Geometric Coefficient of Variation 88.7 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 15 / Pre ARRY-382 dose | 190 nanogram per milliliter | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 241 nanogram per milliliter | Geometric Coefficient of Variation 73.8 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 305 nanogram per milliliter | Geometric Coefficient of Variation 62 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 313 nanogram per milliliter | Geometric Coefficient of Variation 77.8 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 5 Day 1 / Pre ARRY-382 dose | 11.5 nanogram per milliliter | Geometric Coefficient of Variation 4020 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 119 nanogram per milliliter | Geometric Coefficient of Variation 49.5 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 15 / Pre ARRY-382 dose | 210 nanogram per milliliter | Geometric Coefficient of Variation 78.8 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 254 nanogram per milliliter | Geometric Coefficient of Variation 29.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 21.0 nanogram per milliliter | Geometric Coefficient of Variation 234 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 8 Day 1 / Pre ARRY-382 dose | 42.7 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 272 nanogram per milliliter | Geometric Coefficient of Variation 36.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 298 nanogram per milliliter | Geometric Coefficient of Variation 55.6 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 9 Day 1 / Pre ARRY-382 dose | 30.6 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / Pre ARRY-382 dose | 96.5 nanogram per milliliter | Geometric Coefficient of Variation 2860 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 10 Day 1 / Pre ARRY-382 dose | 27.0 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 324 nanogram per milliliter | Geometric Coefficient of Variation 44.1 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 3 Day 1 / Pre ARRY-382 dose | 123 nanogram per milliliter | Geometric Coefficient of Variation 210 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 4 Day 1 / Pre ARRY-382 dose | 157 nanogram per milliliter | Geometric Coefficient of Variation 228 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 7 Day 1 / Pre ARRY-382 dose | 61.5 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 6 Day 1 / Pre ARRY-382 dose | 86.9 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 110 nanogram per milliliter | Geometric Coefficient of Variation 48.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 66.2 nanogram per milliliter | Geometric Coefficient of Variation 80.5 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 510 nanogram per milliliter | Geometric Coefficient of Variation 174 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 113 nanogram per milliliter | Geometric Coefficient of Variation 109 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 6 Day 1 / Pre ARRY-382 dose | 141 nanogram per milliliter | — |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 561 nanogram per milliliter | Geometric Coefficient of Variation 152 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 3 Day 1 / Pre ARRY-382 dose | 70.6 nanogram per milliliter | Geometric Coefficient of Variation 243 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 132 nanogram per milliliter | Geometric Coefficient of Variation 101 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 7.95 nanogram per milliliter | Geometric Coefficient of Variation 493 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 15 / Pre ARRY-382 dose | 250 nanogram per milliliter | Geometric Coefficient of Variation 172 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / Pre ARRY-382 dose | 511 nanogram per milliliter | Geometric Coefficient of Variation 189 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 475 nanogram per milliliter | Geometric Coefficient of Variation 173 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 4 Day 1 / Pre ARRY-382 dose | 138 nanogram per milliliter | Geometric Coefficient of Variation 30 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 544 nanogram per milliliter | Geometric Coefficient of Variation 168 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 54.7 nanogram per milliliter | Geometric Coefficient of Variation 177 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 5 Day 1 / Pre ARRY-382 dose | 170 nanogram per milliliter | Geometric Coefficient of Variation 10.4 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 4 Day 1 / Pre ARRY-382 dose | 70.3 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 7 Day 1 / Pre ARRY-382 dose | 103 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 157 nanogram per milliliter | Geometric Coefficient of Variation 50.7 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 102 nanogram per milliliter | Geometric Coefficient of Variation 68.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 5 Day 1 / Pre ARRY-382 dose | 7.92 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 89.1 nanogram per milliliter | Geometric Coefficient of Variation 39.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 22.6 nanogram per milliliter | Geometric Coefficient of Variation 164 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 133 nanogram per milliliter | Geometric Coefficient of Variation 54.1 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 146 nanogram per milliliter | Geometric Coefficient of Variation 58.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 15 / Pre ARRY-382 dose | 83.3 nanogram per milliliter | Geometric Coefficient of Variation 132 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 75.7 nanogram per milliliter | Geometric Coefficient of Variation 41.6 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 6 Day 1 / Pre ARRY-382 dose | 110 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 2 Day 1 / Pre ARRY-382 dose | 77.1 nanogram per milliliter | Geometric Coefficient of Variation 85.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 3 Day 1 / Pre ARRY-382 dose | 54.0 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 60.8 nanogram per milliliter | Geometric Coefficient of Variation 52.9 |
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469100 was reported in this outcome measure. The LLOQ for analyte AR00469100 was 1.00 ng/mL.
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00469100. Here Number Analyzed signifies number of participants evaluated for given time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / Pre ARRY-382 dose | 60.1 nanogram per milliliter | Geometric Coefficient of Variation 103 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 4 Day 1 / Pre ARRY-382 dose | 31.1 nanogram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 41.7 nanogram per milliliter | Geometric Coefficient of Variation 79.2 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 47.1 nanogram per milliliter | Geometric Coefficient of Variation 109 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 19.5 nanogram per milliliter | Geometric Coefficient of Variation 667 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 5 Day 1 / Pre ARRY-382 dose | NA nanogram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 28.2 nanogram per milliliter | Geometric Coefficient of Variation 71.2 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 3 Day 1 / Pre ARRY-382 dose | 63.2 nanogram per milliliter | Geometric Coefficient of Variation 108 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 104 nanogram per milliliter | Geometric Coefficient of Variation 75.9 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 108 nanogram per milliliter | Geometric Coefficient of Variation 108 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 15 / Pre ARRY-382 dose | 70.7 nanogram per milliliter | Geometric Coefficient of Variation 81.2 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 138 nanogram per milliliter | Geometric Coefficient of Variation 81.9 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 105 nanogram per milliliter | Geometric Coefficient of Variation 98.3 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 3 Day 1 / Pre ARRY-382 dose | 57.3 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / Pre ARRY-382 dose | 107 nanogram per milliliter | Geometric Coefficient of Variation 45.5 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 169 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 228 nanogram per milliliter | Geometric Coefficient of Variation 39.5 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 210 nanogram per milliliter | Geometric Coefficient of Variation 27.1 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | NA nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 43.0 nanogram per milliliter | Geometric Coefficient of Variation 468 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 82.7 nanogram per milliliter | Geometric Coefficient of Variation 55.7 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 53.9 nanogram per milliliter | Geometric Coefficient of Variation 42.5 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 15 / Pre ARRY-382 dose | 69.4 nanogram per milliliter | Geometric Coefficient of Variation 24.5 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 196 nanogram per milliliter | Geometric Coefficient of Variation 81.9 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 71.0 nanogram per milliliter | Geometric Coefficient of Variation 96.9 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 16.6 nanogram per milliliter | Geometric Coefficient of Variation 584 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 161 nanogram per milliliter | Geometric Coefficient of Variation 158 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 138 nanogram per milliliter | Geometric Coefficient of Variation 228 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / Pre ARRY-382 dose | 146 nanogram per milliliter | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 268 nanogram per milliliter | Geometric Coefficient of Variation 141 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 67.7 nanogram per milliliter | Geometric Coefficient of Variation 40.5 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 110 nanogram per milliliter | Geometric Coefficient of Variation 40.5 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 219 nanogram per milliliter | Geometric Coefficient of Variation 131 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 15 / Pre ARRY-382 dose | 116 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 116 nanogram per milliliter | Geometric Coefficient of Variation 75.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 165 nanogram per milliliter | Geometric Coefficient of Variation 81.7 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 139 nanogram per milliliter | Geometric Coefficient of Variation 57.4 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 65.4 nanogram per milliliter | Geometric Coefficient of Variation 64.8 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 3 Day 1 / Pre ARRY-382 dose | 73.2 nanogram per milliliter | Geometric Coefficient of Variation 73.5 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 4 Day 1 / Pre ARRY-382 dose | 108 nanogram per milliliter | Geometric Coefficient of Variation 109 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 5 Day 1 / Pre ARRY-382 dose | 14.0 nanogram per milliliter | Geometric Coefficient of Variation 6560 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 7 Day 1 / Pre ARRY-382 dose | 73.2 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 8 Day 1 / Pre ARRY-382 dose | 51.3 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 9 Day 1 / Pre ARRY-382 dose | 44.0 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 10 Day 1 / Pre ARRY-382 dose | 33.8 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 61.0 nanogram per milliliter | Geometric Coefficient of Variation 337 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 114 nanogram per milliliter | Geometric Coefficient of Variation 69.1 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 102 nanogram per milliliter | Geometric Coefficient of Variation 62 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 6 Day 1 / Pre ARRY-382 dose | 110 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 124 nanogram per milliliter | Geometric Coefficient of Variation 39.5 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / Pre ARRY-382 dose | 35.2 nanogram per milliliter | Geometric Coefficient of Variation 977 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 15 / Pre ARRY-382 dose | 106 nanogram per milliliter | Geometric Coefficient of Variation 94.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 218 nanogram per milliliter | Geometric Coefficient of Variation 74.8 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 85.5 nanogram per milliliter | Geometric Coefficient of Variation 84.8 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 265 nanogram per milliliter | Geometric Coefficient of Variation 65.5 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 4 Day 1 / Pre ARRY-382 dose | 75.5 nanogram per milliliter | Geometric Coefficient of Variation 88.7 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 264 nanogram per milliliter | Geometric Coefficient of Variation 75.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 81.9 nanogram per milliliter | Geometric Coefficient of Variation 150 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 5 Day 1 / Pre ARRY-382 dose | 112 nanogram per milliliter | Geometric Coefficient of Variation 46.2 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 56.4 nanogram per milliliter | Geometric Coefficient of Variation 83.3 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 21.3 nanogram per milliliter | Geometric Coefficient of Variation 553 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 3 Day 1 / Pre ARRY-382 dose | 54.8 nanogram per milliliter | Geometric Coefficient of Variation 255 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / Pre ARRY-382 dose | 184 nanogram per milliliter | Geometric Coefficient of Variation 91.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 191 nanogram per milliliter | Geometric Coefficient of Variation 92.5 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 6 Day 1 / Pre ARRY-382 dose | 148 nanogram per milliliter | — |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 15 / Pre ARRY-382 dose | 96.0 nanogram per milliliter | Geometric Coefficient of Variation 85.3 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 3 Day 1 / Pre ARRY-382 dose | 32.7 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 7 Day 1 / Pre ARRY-382 dose | 67.4 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 44.0 nanogram per milliliter | Geometric Coefficient of Variation 50.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 164 nanogram per milliliter | Geometric Coefficient of Variation 67.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 15 / Pre ARRY-382 dose | 60.8 nanogram per milliliter | Geometric Coefficient of Variation 121 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 5 Day 1 / Pre ARRY-382 dose | 11.7 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 6 Day 1 / Pre ARRY-382 dose | 72.8 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 173 nanogram per milliliter | Geometric Coefficient of Variation 39.1 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 226 nanogram per milliliter | Geometric Coefficient of Variation 66.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 123 nanogram per milliliter | Geometric Coefficient of Variation 51.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 75.4 nanogram per milliliter | Geometric Coefficient of Variation 131 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 4 Day 1 / Pre ARRY-382 dose | 67.6 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 107 nanogram per milliliter | Geometric Coefficient of Variation 77.8 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 2 Day 1 / Pre ARRY-382 dose | 57.1 nanogram per milliliter | Geometric Coefficient of Variation 99.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 101 nanogram per milliliter | Geometric Coefficient of Variation 46.8 |
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00470870 was reported in this outcome measure. The LLOQ for analyte AR00470870 was 1.00 ng/mL.
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00470870. Here Number Analyzed signifies number of participants evaluated for given time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / Pre ARRY-382 dose | 99.1 nanogram per milliliter | Geometric Coefficient of Variation 80.8 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 4 Day 1 / Pre ARRY-382 dose | 77.4 nanogram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 165 nanogram per milliliter | Geometric Coefficient of Variation 49.3 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 149 nanogram per milliliter | Geometric Coefficient of Variation 54.4 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 122 nanogram per milliliter | Geometric Coefficient of Variation 63.9 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 64.5 nanogram per milliliter | Geometric Coefficient of Variation 101 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 14.6 nanogram per milliliter | Geometric Coefficient of Variation 835 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 49.4 nanogram per milliliter | Geometric Coefficient of Variation 193 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 53.7 nanogram per milliliter | Geometric Coefficient of Variation 78.4 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 151 nanogram per milliliter | Geometric Coefficient of Variation 58.9 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 5 Day 1 / Pre ARRY-382 dose | NA nanogram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 15 / Pre ARRY-382 dose | 105 nanogram per milliliter | Geometric Coefficient of Variation 86.9 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 3 Day 1 / Pre ARRY-382 dose | 118 nanogram per milliliter | Geometric Coefficient of Variation 88.7 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / Pre ARRY-382 dose | 294 nanogram per milliliter | Geometric Coefficient of Variation 49.3 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 36.7 nanogram per milliliter | Geometric Coefficient of Variation 2940 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 460 nanogram per milliliter | Geometric Coefficient of Variation 37.6 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | NA nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 3 Day 1 / Pre ARRY-382 dose | 250 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 159 nanogram per milliliter | Geometric Coefficient of Variation 106 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 444 nanogram per milliliter | Geometric Coefficient of Variation 29 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 503 nanogram per milliliter | Geometric Coefficient of Variation 26.8 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 15 / Pre ARRY-382 dose | 255 nanogram per milliliter | Geometric Coefficient of Variation 11 |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 377 nanogram per milliliter | — |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 144 nanogram per milliliter | Geometric Coefficient of Variation 71.3 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 206 nanogram per milliliter | Geometric Coefficient of Variation 68.5 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 327 nanogram per milliliter | Geometric Coefficient of Variation 61.2 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 68.7 nanogram per milliliter | Geometric Coefficient of Variation 113 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 11.7 nanogram per milliliter | Geometric Coefficient of Variation 410 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 182 nanogram per milliliter | Geometric Coefficient of Variation 73.7 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 162 nanogram per milliliter | Geometric Coefficient of Variation 52.6 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 15 / Pre ARRY-382 dose | 231 nanogram per milliliter | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / Pre ARRY-382 dose | 216 nanogram per milliliter | — |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 283 nanogram per milliliter | Geometric Coefficient of Variation 68.8 |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 306 nanogram per milliliter | Geometric Coefficient of Variation 47.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / Pre ARRY-382 dose | 83.4 nanogram per milliliter | Geometric Coefficient of Variation 2600 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 46.9 nanogram per milliliter | Geometric Coefficient of Variation 403 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 140 nanogram per milliliter | Geometric Coefficient of Variation 97.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 150 nanogram per milliliter | Geometric Coefficient of Variation 56.8 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 244 nanogram per milliliter | Geometric Coefficient of Variation 58.1 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 337 nanogram per milliliter | Geometric Coefficient of Variation 70.2 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 320 nanogram per milliliter | Geometric Coefficient of Variation 65.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 337 nanogram per milliliter | Geometric Coefficient of Variation 55.3 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 3 Day 1 / Pre ARRY-382 dose | 156 nanogram per milliliter | Geometric Coefficient of Variation 87 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 6 Day 1 / Pre ARRY-382 dose | 73.5 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 8 Day 1 / Pre ARRY-382 dose | 62.8 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 9 Day 1 / Pre ARRY-382 dose | 73.8 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 10 Day 1 / Pre ARRY-382 dose | 90.6 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 4 Day 1 / Pre ARRY-382 dose | 161 nanogram per milliliter | Geometric Coefficient of Variation 113 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 5 Day 1 / Pre ARRY-382 dose | 16.4 nanogram per milliliter | Geometric Coefficient of Variation 10600 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 7 Day 1 / Pre ARRY-382 dose | 60.7 nanogram per milliliter | — |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 191 nanogram per milliliter | Geometric Coefficient of Variation 59.9 |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 15 / Pre ARRY-382 dose | 259 nanogram per milliliter | Geometric Coefficient of Variation 49.3 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 12.6 nanogram per milliliter | Geometric Coefficient of Variation 1100 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 15 / Pre ARRY-382 dose | 307 nanogram per milliliter | Geometric Coefficient of Variation 74 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 348 nanogram per milliliter | Geometric Coefficient of Variation 40.3 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 5 Day 1 / Pre ARRY-382 dose | 268 nanogram per milliliter | Geometric Coefficient of Variation 18.2 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 129 nanogram per milliliter | Geometric Coefficient of Variation 116 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 345 nanogram per milliliter | Geometric Coefficient of Variation 36.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 310 nanogram per milliliter | Geometric Coefficient of Variation 47.2 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / Pre ARRY-382 dose | 285 nanogram per milliliter | Geometric Coefficient of Variation 58.4 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 4 Day 1 / Pre ARRY-382 dose | 263 nanogram per milliliter | Geometric Coefficient of Variation 13.5 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 123 nanogram per milliliter | Geometric Coefficient of Variation 90.1 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 6 Day 1 / Pre ARRY-382 dose | 419 nanogram per milliliter | — |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 3 Day 1 / Pre ARRY-382 dose | 194 nanogram per milliliter | Geometric Coefficient of Variation 65 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 279 nanogram per milliliter | Geometric Coefficient of Variation 53.8 |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 74.8 nanogram per milliliter | Geometric Coefficient of Variation 277 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose | 189 nanogram per milliliter | Geometric Coefficient of Variation 59.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose | 401 nanogram per milliliter | Geometric Coefficient of Variation 19.2 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 3 Day 1 / Pre ARRY-382 dose | 194 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 4 Day 1 / Pre ARRY-382 dose | 158 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 8 hrs Post ARRY-382 dose | 148 nanogram per milliliter | Geometric Coefficient of Variation 46.7 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 6 Day 1 / Pre ARRY-382 dose | 192 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose | 486 nanogram per milliliter | Geometric Coefficient of Variation 18.9 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day1 / 4 hrs Post ARRY-382 dose | 220 nanogram per milliliter | Geometric Coefficient of Variation 46.9 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 1 / 1 hr Post ARRY-382 dose | 71.7 nanogram per milliliter | Geometric Coefficient of Variation 125 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 1 Day 15 / Pre ARRY-382 dose | 242 nanogram per milliliter | Geometric Coefficient of Variation 33.5 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose | 462 nanogram per milliliter | Geometric Coefficient of Variation 16.9 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / 1 hr Post ARRY-382 dose | 316 nanogram per milliliter | Geometric Coefficient of Variation 26.4 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 5 Day 1 / Pre ARRY-382 dose | 33.8 nanogram per milliliter | — |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 2 Day 1 / Pre ARRY-382 dose | 224 nanogram per milliliter | Geometric Coefficient of Variation 34.1 |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 | Cycle 7 Day 1 / Pre ARRY-382 dose | 236 nanogram per milliliter | — |
Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)
PFS was defined as the time from the date of first dose of study drug to the earliest date of disease progression per RECIST v1.1, or death due to any cause, whichever occurs first. If a participant did not have a PFS event at the time of the analysis cut-off or at the start of any new anticancer therapy, PFS was censored at the date of last adequate tumor assessment. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Time frame: From day of first dose until disease progression or death due to any cause or till last tumor assessment date (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS) | 4.7 months |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS) | 2.3 months |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS) | 1.4 months |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS) | 1.6 months |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS) | 1.4 months |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS) | 2.1 months |
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Tmax was obtained from plasma concentration time curve. Tmax at single dose was reported at Cycle 1 Day 1 and Tmax at steady state was reported at Cycle 2 Day 1.
Time frame: Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here Number Analyzed signifies number of participants evaluated for given time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 2.00 hours |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 2.00 hours |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 2.00 hours |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 3.00 hours |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 2.00 hours |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 7.94 hours |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 3.00 hours |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 7.98 hours |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 4.03 hours |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 7.68 hours |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 4.01 hours |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 4.18 hours |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 2.98 hours |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 7.81 hours |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 4.18 hours |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 3.03 hours |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 4.07 hours |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 7.95 hours |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 8.00 hours |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 4.07 hours |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 1.98 hours |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 1.98 hours |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 4.07 hours |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 8.00 hours |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 7.50 hours |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 4.03 hours |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 2.00 hours |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 4.00 hours |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 1.97 hours |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 1.98 hours |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 5.88 hours |
| Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 2.00 hours |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 5.83 hours |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 3.90 hours |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 5.90 hours |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 2.00 hours |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 5.78 hours |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 4.07 hours |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 2.00 hours |
| Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 3.03 hours |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 ARRY-382 | 2.00 hours |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469100 | 2.00 hours |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469099 | 4.05 hours |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00469099 | 4.17 hours |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00470870 | 4.05 hours |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 AR00469100 | 2.00 hours |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 2 Day 1 ARRY-382 | 2.00 hours |
| Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort | Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) | Cycle 1 Day 1 AR00470870 | 3.80 hours |
Phase 1b, Part A: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator review of radiographic disease assessments per RECIST v1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.
Time frame: From day of first dose to 30 days after last dose (maximum up to 34.7 months)
Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A: Objective Response Rate (ORR) | 16.7 percentage of participants |
| Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A: Objective Response Rate (ORR) | 16.7 percentage of participants |
| Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 1b, Part A: Objective Response Rate (ORR) | 0.0 percentage of participants |
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation
Tumor markers were measured for tumor type from serum samples obtained from participants in Phase 2. Mean change from baseline was reported in this outcome measure.
Time frame: Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment discontinuation (before 13.5 months)
Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. This outcome measure was planned in prOVCA cohort. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 1 Day 1 | 578.6 microgram per milliliter | Standard Deviation 626.3302643 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 1 Day 8 | 803.3181818 microgram per milliliter | Standard Deviation 808.9155788 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 1 Day 15 | 1279.833333 microgram per milliliter | Standard Deviation 1298.144638 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 2 Day 1 | 1485.6 microgram per milliliter | Standard Deviation 1368.310653 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 3 Day 1 | 1558.4 microgram per milliliter | Standard Deviation 1502.22728 |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 4 Day 1 | 1980 microgram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 5 Day 1 | 778 microgram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 6 Day 1 | 1730 microgram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Cycle 7 Day 1 | 2080 microgram per milliliter | — |
| Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab | Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation | Treatment discontinuation | 1743.833333 microgram per milliliter | Standard Deviation 1817.18193 |