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A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

A Phase 1b/2 Study of ARRY-382 in Combination With Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients With Advanced Solid Tumors

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02880371
Enrollment
82
Registered
2016-08-26
Start date
2016-09-01
Completion date
2019-10-24
Last updated
2022-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

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

DRUGARRY-382

ARRAY-382 will be taken by mouth once daily at a fixed dose.

DRUGPembrolizumab

Pembrolizumab will be administered intravenously over 30 minutes every 3 weeks.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
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

MeasureTime frameDescription
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 DiscontinuationBaseline, 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 4.03First 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 4.03First 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 TestsFirst 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 GradesBaseline, 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 FindingFirst 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-382Pre 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, 2The 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 AR00469099Pre 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, 2Drug 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 AR00469100Pre 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, 2Drug 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 AR00470870Pre 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, 2Drug 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 2AUCtau 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 2Cmax 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 2Measured 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 2Tmax 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 2Different 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 2Accumulation 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 AbnormalitiesFirst 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

ArmCount
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
Total79

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Phase 1bDeath46510000
Phase 1bEnrolled but not Treated01000000
Phase 1bLost to Follow-up10000000
Phase 1bParticipants terminated by Sponsor10000000
Phase 1bWithdrawal by Subject00100000
Phase 2Death0000110205
Phase 2End of Study page not completed by error00000100
Phase 2Enrolled but not Treated00000110
Phase 2Lost to Follow-up00000030
Phase 2Other00000121
Phase 2Participants terminated by Sponsor00001615
Phase 2Withdrawal by Subject00000110

Baseline characteristics

CharacteristicPhase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 2, Part C: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortTotal
Age, Continuous63.7 years
STANDARD_DEVIATION 12.4
52.2 years
STANDARD_DEVIATION 16
54.7 years
STANDARD_DEVIATION 12.9
68.0 years47.0 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 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants6 Participants7 Participants1 Participants2 Participants18 Participants23 Participants10 Participants72 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants3 Participants1 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants3 Participants2 Participants0 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants2 Participants1 Participants5 Participants
Race (NIH/OMB)
White
5 Participants6 Participants7 Participants1 Participants2 Participants15 Participants23 Participants9 Participants68 Participants
Sex: Female, Male
Female
2 Participants3 Participants4 Participants0 Participants0 Participants12 Participants12 Participants11 Participants44 Participants
Sex: Female, Male
Male
4 Participants3 Participants3 Participants1 Participants2 Participants7 Participants15 Participants0 Participants35 Participants

Adverse events

Event typeEG000
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 / 66 / 65 / 71 / 11 / 210 / 1920 / 275 / 11
other
Total, other adverse events
6 / 66 / 66 / 71 / 12 / 219 / 1926 / 2710 / 11
serious
Total, serious adverse events
3 / 61 / 63 / 71 / 11 / 28 / 1915 / 275 / 11

Outcome results

Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT)1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT)2 Participants
Primary

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.

ArmMeasureValue (NUMBER)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 2 Cohorts: Objective Response Rate (ORR)0.0 percentage of participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 2 Cohorts: Objective Response Rate (ORR)3.7 percentage of participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 2 Cohorts: Objective Response Rate (ORR)0.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RCmax3.03 ratioGeometric Coefficient of Variation 53.4
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RAUC3.47 ratioGeometric Coefficient of Variation 94.9
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RCmax2.72 ratioGeometric Coefficient of Variation 54.5
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RAUC3.49 ratioGeometric Coefficient of Variation 51.7
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RAUC4.03 ratioGeometric Coefficient of Variation 93
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 RAUC3.03 ratioGeometric Coefficient of Variation 47.9
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 RCmax2.53 ratioGeometric Coefficient of Variation 48.2
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RCmax2.67 ratioGeometric Coefficient of Variation 46.1
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RAUC1.97 ratio
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 RCmax2.51 ratioGeometric Coefficient of Variation 95.7
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RCmax2.60 ratioGeometric Coefficient of Variation 157
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RCmax2.54 ratioGeometric Coefficient of Variation 52
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RAUC4.48 ratio
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RAUC4.36 ratio
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 RAUC1.92 ratio
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RCmax3.59 ratioGeometric Coefficient of Variation 95.3
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RCmax2.50 ratioGeometric Coefficient of Variation 65.1
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RAUC3.96 ratio
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RAUC2.73 ratio
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 RAUC3.52 ratio
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RCmax2.02 ratioGeometric Coefficient of Variation 20.1
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 RCmax2.28 ratioGeometric Coefficient of Variation 54.2
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RAUC4.28 ratio
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RCmax2.47 ratioGeometric Coefficient of Variation 38.5
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RAUC2.64 ratioGeometric Coefficient of Variation 36.3
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 RAUC2.67 ratioGeometric Coefficient of Variation 36.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RCmax2.39 ratioGeometric Coefficient of Variation 48.6
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RAUC4.01 ratio
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RCmax3.19 ratioGeometric Coefficient of Variation 36.7
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RCmax2.44 ratioGeometric Coefficient of Variation 41.3
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 RCmax2.52 ratioGeometric Coefficient of Variation 39.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RAUC4.67 ratio
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RAUC3.30 ratioGeometric Coefficient of Variation 61.9
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 RCmax2.07 ratioGeometric Coefficient of Variation 53.6
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RCmax2.08 ratioGeometric Coefficient of Variation 49
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 RAUC3.41 ratioGeometric Coefficient of Variation 23.6
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RAUC4.95 ratioGeometric Coefficient of Variation 41.8
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RCmax3.56 ratioGeometric Coefficient of Variation 48.4
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RAUC3.84 ratioGeometric Coefficient of Variation 13.5
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RCmax2.03 ratioGeometric Coefficient of Variation 38.7
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RCmax1.76 ratioGeometric Coefficient of Variation 29.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RAUC2.03 ratioGeometric Coefficient of Variation 23.9
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RCmax1.93 ratioGeometric Coefficient of Variation 37.4
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469099 RAUC2.07 ratioGeometric Coefficient of Variation 23.8
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 RAUC1.87 ratioGeometric Coefficient of Variation 16.7
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 RCmax1.62 ratioGeometric Coefficient of Variation 24.7
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00470870 RCmax1.77 ratioGeometric Coefficient of Variation 31
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)Cycle 2 Day 1 AR00469100 RAUC1.93 ratioGeometric Coefficient of Variation 23
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004691002170 hour*nanogram per milliliterGeometric Coefficient of Variation 85.9
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004708703180 hour*nanogram per milliliterGeometric Coefficient of Variation 59
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004690994150 hour*nanogram per milliliterGeometric Coefficient of Variation 63.5
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-38222800 hour*nanogram per milliliterGeometric Coefficient of Variation 44.2
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-38230600 hour*nanogram per milliliterGeometric Coefficient of Variation 26.6
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004691003860 hour*nanogram per milliliterGeometric Coefficient of Variation 33.9
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004708709810 hour*nanogram per milliliterGeometric Coefficient of Variation 29.3
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004690994530 hour*nanogram per milliliterGeometric Coefficient of Variation 106
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-38230800 hour*nanogram per milliliterGeometric Coefficient of Variation 130
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004690995880 hour*nanogram per milliliterGeometric Coefficient of Variation 78.8
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004708706200 hour*nanogram per milliliterGeometric Coefficient of Variation 45.2
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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)AR004691003510 hour*nanogram per milliliterGeometric Coefficient of Variation 142
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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)AR004691002670 hour*nanogram per milliliterGeometric Coefficient of Variation 53.4
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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)AR004690997920 hour*nanogram per milliliterGeometric Coefficient of Variation 18.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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)AR004708706850 hour*nanogram per milliliterGeometric Coefficient of Variation 61.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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-38232100 hour*nanogram per milliliterGeometric Coefficient of Variation 65.7
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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)AR004691005360 hour*nanogram per milliliterGeometric Coefficient of Variation 62.8
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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-38247100 hour*nanogram per milliliterGeometric Coefficient of Variation 10.2
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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)AR004708707940 hour*nanogram per milliliterGeometric Coefficient of Variation 36.9
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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)AR0046909914200 hour*nanogram per milliliterGeometric Coefficient of Variation 123
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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)AR004690992840 hour*nanogram per milliliterGeometric Coefficient of Variation 61.8
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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)AR004691002480 hour*nanogram per milliliterGeometric Coefficient of Variation 73.9
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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)AR004708708220 hour*nanogram per milliliterGeometric Coefficient of Variation 20.3
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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-38220700 hour*nanogram per milliliterGeometric Coefficient of Variation 70.6
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR0046910060.1 nanogram per milliliterGeometric Coefficient of Variation 103
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00469099136 nanogram per milliliterGeometric Coefficient of Variation 67.7
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)ARRY-382576 nanogram per milliliterGeometric Coefficient of Variation 59.5
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR0047087099.1 nanogram per milliliterGeometric Coefficient of Variation 80.8
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00469099146 nanogram per milliliterGeometric Coefficient of Variation 105
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR0046910096.0 nanogram per milliliterGeometric Coefficient of Variation 43.9
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00470870313 nanogram per milliliterGeometric Coefficient of Variation 41.7
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)ARRY-382667 nanogram per milliliterGeometric Coefficient of Variation 27.7
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00469099161 nanogram per milliliterGeometric Coefficient of Variation 105
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)ARRY-382627 nanogram per milliliterGeometric Coefficient of Variation 126
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR0046910083.6 nanogram per milliliterGeometric Coefficient of Variation 137
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00470870185 nanogram per milliliterGeometric Coefficient of Variation 27.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR0046910082.4 nanogram per milliliterGeometric Coefficient of Variation 57.1
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)ARRY-382878 nanogram per milliliterGeometric Coefficient of Variation 70.1
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00469099277 nanogram per milliliterGeometric Coefficient of Variation 27.1
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00470870232 nanogram per milliliterGeometric Coefficient of Variation 58.5
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)ARRY-3821480 nanogram per milliliterGeometric Coefficient of Variation 17.5
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00469099557 nanogram per milliliterGeometric Coefficient of Variation 136
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00469100193 nanogram per milliliterGeometric Coefficient of Variation 71.3
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00470870302 nanogram per milliliterGeometric Coefficient of Variation 48.1
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR0046909977.1 nanogram per milliliterGeometric Coefficient of Variation 85.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)ARRY-382438 nanogram per milliliterGeometric Coefficient of Variation 86.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR00470870224 nanogram per milliliterGeometric Coefficient of Variation 34.1
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)AR0046910057.1 nanogram per milliliterGeometric Coefficient of Variation 99.2
Secondary

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.

ArmMeasureValue (MEDIAN)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR)3.1 months
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR)2.4 months
Secondary

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.

ArmMeasureValue (MEDIAN)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 PembrolizumabPhase 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 PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)1.3 months
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)1.5 months
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)1.3 months
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)2.5 months
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR0046910061.2 nanogram per milliliterGeometric Coefficient of Variation 78.3
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR0046909984.0 nanogram per milliliterGeometric Coefficient of Variation 102
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469100138 nanogram per milliliterGeometric Coefficient of Variation 81.6
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469099212 nanogram per milliliterGeometric Coefficient of Variation 57.3
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-382773 nanogram per milliliterGeometric Coefficient of Variation 60.2
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00470870172 nanogram per milliliterGeometric Coefficient of Variation 51.6
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3821560 nanogram per milliliterGeometric Coefficient of Variation 41.3
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR0047087070.1 nanogram per milliliterGeometric Coefficient of Variation 95.1
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3822260 nanogram per milliliterGeometric Coefficient of Variation 36.6
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00470870534 nanogram per milliliterGeometric Coefficient of Variation 22
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-382995 nanogram per milliliterGeometric Coefficient of Variation 68.9
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469100104 nanogram per milliliterGeometric Coefficient of Variation 86.5
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469099100 nanogram per milliliterGeometric Coefficient of Variation 59.8
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469099241 nanogram per milliliterGeometric Coefficient of Variation 103
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00470870174 nanogram per milliliterGeometric Coefficient of Variation 92.5
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469100257 nanogram per milliliterGeometric Coefficient of Variation 36.4
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469099219 nanogram per milliliterGeometric Coefficient of Variation 83.8
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469100122 nanogram per milliliterGeometric Coefficient of Variation 41.7
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00470870333 nanogram per milliliterGeometric Coefficient of Variation 60.7
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3822560 nanogram per milliliterGeometric Coefficient of Variation 117
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3821330 nanogram per milliliterGeometric Coefficient of Variation 39.6
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469099328 nanogram per milliliterGeometric Coefficient of Variation 75.6
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00470870196 nanogram per milliliterGeometric Coefficient of Variation 58.5
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR00469100268 nanogram per milliliterGeometric Coefficient of Variation 141
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR00469099119 nanogram per milliliterGeometric Coefficient of Variation 50.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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-3822130 nanogram per milliliterGeometric Coefficient of Variation 60.4
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR00469099328 nanogram per milliliterGeometric Coefficient of Variation 44
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR00469100132 nanogram per milliliterGeometric Coefficient of Variation 70
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR00469100181 nanogram per milliliterGeometric Coefficient of Variation 56.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR00470870193 nanogram per milliliterGeometric Coefficient of Variation 60.5
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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-3821240 nanogram per milliliterGeometric Coefficient of Variation 62.1
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR00470870373 nanogram per milliliterGeometric Coefficient of Variation 60.6
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR00470870147 nanogram per milliliterGeometric Coefficient of Variation 98.9
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR00470870363 nanogram per milliliterGeometric Coefficient of Variation 30.9
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR00469100116 nanogram per milliliterGeometric Coefficient of Variation 98.3
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR00469099646 nanogram per milliliterGeometric Coefficient of Variation 111
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR00469099142 nanogram per milliliterGeometric Coefficient of Variation 97.9
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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-3822820 nanogram per milliliterGeometric Coefficient of Variation 15.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR00469100279 nanogram per milliliterGeometric Coefficient of Variation 54.9
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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-3821290 nanogram per milliliterGeometric Coefficient of Variation 75.6
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR00470870486 nanogram per milliliterGeometric Coefficient of Variation 18.9
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR00470870231 nanogram per milliliterGeometric Coefficient of Variation 50.8
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR00469100215 nanogram per milliliterGeometric Coefficient of Variation 52.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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-3821260 nanogram per milliliterGeometric Coefficient of Variation 53.9
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR0046909995.4 nanogram per milliliterGeometric Coefficient of Variation 43.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR00469100138 nanogram per milliliterGeometric Coefficient of Variation 46.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR00469099161 nanogram per milliliterGeometric Coefficient of Variation 50.8
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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-3821580 nanogram per milliliterGeometric Coefficient of Variation 64.8
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.0978 ratioGeometric Coefficient of Variation 43.8
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.0817 ratioGeometric Coefficient of Variation 40.7
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.0811 ratioGeometric Coefficient of Variation 45
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.0909 ratioGeometric Coefficient of Variation 41.4
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.0775 ratioGeometric Coefficient of Variation 119
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.0941 ratioGeometric Coefficient of Variation 84.4
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.115 ratioGeometric Coefficient of Variation 86.8
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.0946 ratioGeometric Coefficient of Variation 104
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.106 ratioGeometric Coefficient of Variation 58.8
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.119 ratioGeometric Coefficient of Variation 80.2
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.177 ratioGeometric Coefficient of Variation 35.6
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.132 ratioGeometric Coefficient of Variation 20.5
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.116 ratioGeometric Coefficient of Variation 29.3
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.201 ratioGeometric Coefficient of Variation 36.1
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.159 ratioGeometric Coefficient of Variation 42.7
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.144 ratioGeometric Coefficient of Variation 80.3
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.101 ratioGeometric Coefficient of Variation 47.9
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.129 ratioGeometric Coefficient of Variation 27.1
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.107 ratioGeometric Coefficient of Variation 35
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.0979 ratioGeometric Coefficient of Variation 74.9
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.101 ratioGeometric Coefficient of Variation 33.4
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.273 ratioGeometric Coefficient of Variation 43.1
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.149 ratioGeometric Coefficient of Variation 26.6
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.103 ratioGeometric Coefficient of Variation 68.2
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.0934 ratioGeometric Coefficient of Variation 31
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.0941 ratioGeometric Coefficient of Variation 21.8
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.111 ratioGeometric Coefficient of Variation 42.7
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.186 ratioGeometric Coefficient of Variation 84.6
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.127 ratioGeometric Coefficient of Variation 44.9
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.125 ratioGeometric Coefficient of Variation 74.8
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.160 ratioGeometric Coefficient of Variation 79.5
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.172 ratioGeometric Coefficient of Variation 66.7
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRAUClast0.151 ratioGeometric Coefficient of Variation 70.9
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 MRCmax0.126 ratioGeometric Coefficient of Variation 30.4
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.117 ratioGeometric Coefficient of Variation 13.1
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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,ss0.108 ratioGeometric Coefficient of Variation 24.5
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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,ss0.150 ratioGeometric Coefficient of Variation 89.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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,ss0.240 ratioGeometric Coefficient of Variation 69
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 MRCmax0.133 ratioGeometric Coefficient of Variation 78
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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,ss0.182 ratioGeometric Coefficient of Variation 69.3
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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,ss0.150 ratioGeometric Coefficient of Variation 66.6
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 MRAUClast0.101 ratioGeometric Coefficient of Variation 45.7
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 MRCmax0.0929 ratioGeometric Coefficient of Variation 46.5
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 MRAUClast0.104 ratioGeometric Coefficient of Variation 39.3
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 MRCmax0.109 ratioGeometric Coefficient of Variation 47.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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,ss0.0853 ratioGeometric Coefficient of Variation 13.8
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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,ss0.0873 ratioGeometric Coefficient of Variation 19.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 MRAUClast0.151 ratioGeometric Coefficient of Variation 71.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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,ss0.222 ratioGeometric Coefficient of Variation 108
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 MRCmax0.0923 ratioGeometric Coefficient of Variation 41.3
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 MRCmax0.107 ratioGeometric Coefficient of Variation 71.8
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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,ss0.292 ratioGeometric Coefficient of Variation 132
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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,ss0.144 ratioGeometric Coefficient of Variation 41.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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,ss0.117 ratioGeometric Coefficient of Variation 66.4
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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,ss0.101 ratioGeometric Coefficient of Variation 52.8
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 MRAUClast0.108 ratioGeometric Coefficient of Variation 63.4
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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,ss0.110 ratioGeometric Coefficient of Variation 31.3
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 MRCmax0.0974 ratioGeometric Coefficient of Variation 51.4
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 MRAUClast0.106 ratioGeometric Coefficient of Variation 64
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 MRAUClast0.0883 ratioGeometric Coefficient of Variation 41.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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,ss0.0991 ratioGeometric Coefficient of Variation 24
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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,ss0.140 ratioGeometric Coefficient of Variation 44.3
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 MRCmax0.112 ratioGeometric Coefficient of Variation 29.8
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 MRAUClast0.176 ratioGeometric Coefficient of Variation 72.4
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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,ss0.134 ratioGeometric Coefficient of Variation 27.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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,ss0.263 ratioGeometric Coefficient of Variation 59.6
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 MRAUClast0.108 ratioGeometric Coefficient of Variation 22.9
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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,ss0.340 ratioGeometric Coefficient of Variation 59
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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,ss0.123 ratioGeometric Coefficient of Variation 40.8
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 MRCmax0.0734 ratioGeometric Coefficient of Variation 38.3
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 MRAUClast0.0821 ratioGeometric Coefficient of Variation 31.3
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 MRCmax0.156 ratioGeometric Coefficient of Variation 71.6
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >5*ULN1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >20*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALP >3*ULN and Total Bilirubin >2*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >3*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >8*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >3*ULN2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >10*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >2*ULN1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >20*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >10*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >20*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >2*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >3*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >3*ULN1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >10*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >8*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >5*ULN1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >5*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >3*ULN2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >10*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >8*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >1.5*ULN0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >5*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >3*ULN2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >5*ULN2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >5*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >20*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >20*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >8*ULN1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >10*ULN1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALP >3*ULN and Total Bilirubin >2*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >10*ULN1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >8*ULN1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >3*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >5*ULN2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >20*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >3*ULN3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >8*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >2*ULN3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >10*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >2*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >3*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >1.5*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >3*ULN3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >10*ULN0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >5*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALP >3*ULN and Total Bilirubin >2*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >5*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >10*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >10*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >20*ULN0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >2*ULN2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >3*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >3*ULN4 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >5*ULN2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >5*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >8*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >10*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >20*ULN0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >1.5*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >2*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >3*ULN4 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >5*ULN2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >8*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >8*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >10*ULN1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >20*ULN0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >3*ULN2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >3*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >3*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >10*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >10*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >8*ULN2 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >20*ULN0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >8*ULN2 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >20*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALP >3*ULN and Total Bilirubin >2*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >5*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >10*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >3*ULN7 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >5*ULN2 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >2*ULN5 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >8*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >1.5*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >10*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >3*ULN3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >2*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >3*ULN7 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >5*ULN4 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >5*ULN4 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >20*ULN1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >3*ULN4 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >20*ULN0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >3*ULN9 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >1.5*ULN5 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >2*ULN12 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >3*ULN4 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >2*ULN4 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >3*ULN2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >20*ULN0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >3*ULN13 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >10*ULN1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >20*ULN0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >5*ULN5 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >5*ULN0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >8*ULN1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALP >3*ULN and Total Bilirubin >2*ULN3 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >10*ULN1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >8*ULN1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >8*ULN1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >10*ULN1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >5*ULN1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >5*ULN5 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >10*ULN0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >3*ULN13 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >3*ULN5 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >3*ULN4 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >5*ULN3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >8*ULN3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >10*ULN3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlanine Aminotransferase: >20*ULN1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >2*ULN3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAlkaline Phosphatase: >3*ULN1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >3*ULN5 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >5*ULN2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >8*ULN2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >10*ULN2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsAspartate Aminotransferase: >20*ULN1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >1.5*ULN0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsBilirubin: >2*ULN0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >5*ULN3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >8*ULN3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >10*ULN3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST: AT >20*ULN1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >3*ULN0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >5*ULN0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST and Total Bilirubin >2*ULN: AT >10*ULN0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALP >3*ULN and Total Bilirubin >2*ULN0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function TestsALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: High1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: Low0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: High0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: Low1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: High3 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: Low1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: Low0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: High1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: High0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: Low4 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: Low0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: Low0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: High0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: High1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: High0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: Low1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: Low0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: Low0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: High0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: High0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: Low0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: High0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: High1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: Low0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: High2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: Low0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: High1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: Low2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: High0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: Low0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: High1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: Low0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: High1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: Low0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: High2 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: Low0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: High1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: Low3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: Low0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: High0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: High0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: Low0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: High2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: Low1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: Low1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: Low5 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: High2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: High3 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: High2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: Low1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: Low1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: Low0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: High0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesTemperature: High1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: Low0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: Low0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesWeight: High0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesSBP: High1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesHeart Rate: High0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign AbnormalitiesDBP: Low0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: All Grades2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: All Grades2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: Grade 3/42 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: All Grades2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: All Grades3 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: All Grades4 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: All Grades2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: All Grades3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: All Grades2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: All Grades5 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: Grade 3/42 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: All Grades2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: All Grades3 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: All Grades3 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: All Grades4 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: All Grades12 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: Grade 3/44 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: All Grades0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: All Grades11 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: Grade 3/45 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: All Grades0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: All Grades1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: Grade 3/41 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: All Grades2 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: Grade 3/41 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: Grade 3/41 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: All Grades0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: All Grades6 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/42 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades9 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/42 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: All Grades0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: Grade 3/42 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: All Grades0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: All Grades1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: Grade 3/41 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: All Grades9 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: All Grades7 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: All Grades11 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/42 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: All Grades0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/41 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades15 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: All Grades2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: All Grades2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: Grade 3/42 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: All Grades3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: All Grades1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: All Grades1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Neutrophils (10^9/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: All Grades0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hyper: All Grades0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Platelets (10^9/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hypo: All Grades7 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: Grade 3/42 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Hemoglobin (g/L), Hyper: All Grades1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Lymphocytes (10^9/L), Hypo: All Grades5 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03Leukocytes (10^9/L), Hypo: All Grades2 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hyper: All Grades3 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Albumin (g/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Amylase (U/L), Hyper: All Grades3 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Lipase (U/L), Hyper: All Grades5 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (millimoles per liter [mmol/L]), Hypo: All Grades1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Albumin (grams per liter [g/L]), Hypo: All Grades4 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Phosphate (mmol/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Bilirubin (umol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Amylase (U/L), Hyper: Grade 3/42 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hypo: All Grades0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hyper: All Grades1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatinine (umol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: All Grades5 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Phosphate (mmol/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatinine (umol/L), Hyper: All Grades2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatine Kinase (U/L), Hyper: All Grades5 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Lipase (U/L), Hyper: Grade 3/42 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alkaline Phosphatase (U/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hyper: All Grades2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: All Grades2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hypo: All Grades0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades5 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hypo: All Grades3 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatine Kinase (U/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatinine (umol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hypo: All Grades2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hyper: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alkaline Phosphatase (U/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: All Grades3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hypo: All Grades2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Phosphate (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Amylase (U/L), Hyper: All Grades4 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Amylase (U/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Albumin (grams per liter [g/L]), Hypo: All Grades2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Phosphate (mmol/L), Hypo: All Grades3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: All Grades6 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: Grade 3/42 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hyper: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Bilirubin (umol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (millimoles per liter [mmol/L]), Hypo: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Albumin (g/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hypo: All Grades1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Lipase (U/L), Hyper: Grade 3/42 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Lipase (U/L), Hyper: All Grades4 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatine Kinase (U/L), Hyper: All Grades5 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatine Kinase (U/L), Hyper: Grade 3/42 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatinine (umol/L), Hyper: All Grades2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (millimoles per liter [mmol/L]), Hypo: All Grades1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Phosphate (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hypo: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatine Kinase (U/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: All Grades4 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hypo: All Grades3 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hyper: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Albumin (g/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Lipase (U/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades4 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Alkaline Phosphatase (U/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hypo: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Calcium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatinine (umol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hypo: Grade 3/41 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Albumin (grams per liter [g/L]), Hypo: All Grades4 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Lipase (U/L), Hyper: All Grades3 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: Grade 3/42 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatinine (umol/L), Hyper: All Grades1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: All Grades6 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Amylase (U/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Creatine Kinase (U/L), Hyper: All Grades5 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Sodium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hyper: All Grades2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hyper: All Grades1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Phosphate (mmol/L), Hypo: All Grades0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hypo: All Grades3 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Bilirubin (umol/L), Hyper: Grade 3/41 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Potassium (mmol/L), Hyper: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Magnesium (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Glucose (mmol/L), Hypo: Grade 3/40 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 4.03Amylase (U/L), Hyper: All Grades2 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Phosphate (mmol/L), Hypo: All Grades6 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Lipase (U/L), Hyper: All Grades8 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Albumin (grams per liter [g/L]), Hypo: All Grades5 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Albumin (g/L), Hypo: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades11 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Alkaline Phosphatase (U/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: All Grades8 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: Grade 3/42 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Amylase (U/L), Hyper: All Grades11 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Amylase (U/L), Hyper: Grade 3/43 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: All Grades17 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: Grade 3/44 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Bilirubin (umol/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Calcium (millimoles per liter [mmol/L]), Hypo: All Grades1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Calcium (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Calcium (mmol/L), Hyper: All Grades1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Calcium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Creatine Kinase (U/L), Hyper: All Grades16 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Creatine Kinase (U/L), Hyper: Grade 3/43 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Creatinine (umol/L), Hyper: All Grades7 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Creatinine (umol/L), Hyper: Grade 3/41 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Glucose (mmol/L), Hypo: All Grades3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Glucose (mmol/L), Hypo: Grade 3/41 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Glucose (mmol/L), Hyper: All Grades0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Glucose (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Potassium (mmol/L), Hypo: All Grades7 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Potassium (mmol/L), Hypo: Grade 3/42 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Potassium (mmol/L), Hyper: All Grades1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Potassium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Lipase (U/L), Hyper: Grade 3/47 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Magnesium (mmol/L), Hypo: All Grades5 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Magnesium (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Magnesium (mmol/L), Hyper: All Grades3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Magnesium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Phosphate (mmol/L), Hypo: Grade 3/42 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Sodium (mmol/L), Hypo: All Grades8 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Sodium (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Sodium (mmol/L), Hyper: All Grades4 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 4.03Sodium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades17 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: Grade 3/45 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Lipase (U/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Albumin (g/L), Hypo: Grade 3/43 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Magnesium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Potassium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: All Grades23 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Creatinine (umol/L), Hyper: All Grades6 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Calcium (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Amylase (U/L), Hyper: Grade 3/41 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Phosphate (mmol/L), Hypo: All Grades7 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Creatine Kinase (U/L), Hyper: All Grades20 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Amylase (U/L), Hyper: All Grades7 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Sodium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: Grade 3/41 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Magnesium (mmol/L), Hypo: All Grades4 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Phosphate (mmol/L), Hypo: Grade 3/42 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Creatinine (umol/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Calcium (millimoles per liter [mmol/L]), Hypo: All Grades0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: All Grades12 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Lipase (U/L), Hyper: All Grades2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Albumin (grams per liter [g/L]), Hypo: All Grades10 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Sodium (mmol/L), Hypo: All Grades13 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Bilirubin (umol/L), Hyper: Grade 3/43 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Alkaline Phosphatase (U/L), Hyper: Grade 3/44 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Sodium (mmol/L), Hyper: All Grades0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Magnesium (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Glucose (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Creatine Kinase (U/L), Hyper: Grade 3/42 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Glucose (mmol/L), Hyper: All Grades0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Calcium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Glucose (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades7 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Potassium (mmol/L), Hypo: All Grades6 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Potassium (mmol/L), Hyper: All Grades4 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Magnesium (mmol/L), Hyper: All Grades5 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Glucose (mmol/L), Hypo: All Grades1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Calcium (mmol/L), Hyper: All Grades1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Sodium (mmol/L), Hypo: Grade 3/45 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 4.03Potassium (mmol/L), Hypo: Grade 3/41 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: Grade 3/42 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Creatinine (umol/L), Hyper: All Grades2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Sodium (mmol/L), Hypo: Grade 3/41 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Potassium (mmol/L), Hyper: All Grades1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Creatine Kinase (U/L), Hyper: Grade 3/42 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Creatine Kinase (U/L), Hyper: All Grades7 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Potassium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Calcium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Lipase (U/L), Hyper: All Grades5 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Calcium (mmol/L), Hyper: All Grades0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Albumin (g/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Lipase (U/L), Hyper: Grade 3/42 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Calcium (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Calcium (millimoles per liter [mmol/L]), Hypo: All Grades2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Magnesium (mmol/L), Hypo: All Grades3 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Bilirubin (umol/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Magnesium (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Sodium (mmol/L), Hyper: All Grades0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Magnesium (mmol/L), Hyper: All Grades0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Potassium (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Aspartate Aminotransferase (U/L), Hyper: All Grades11 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Magnesium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Amylase (U/L), Hyper: Grade 3/41 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Amylase (U/L), Hyper: All Grades7 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Phosphate (mmol/L), Hypo: All Grades2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: Grade 3/43 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Albumin (grams per liter [g/L]), Hypo: All Grades2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Phosphate (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Alanine Aminotransferase (U/L), Hyper: All Grades7 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Alkaline Phosphatase (U/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Sodium (mmol/L), Hypo: All Grades6 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Glucose (mmol/L), Hyper: All Grades2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades6 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Glucose (mmol/L), Hyper: Grade 3/42 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Glucose (mmol/L), Hypo: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Sodium (mmol/L), Hyper: Grade 3/40 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Potassium (mmol/L), Hypo: All Grades4 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Glucose (mmol/L), Hypo: All Grades0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 4.03Creatinine (umol/L), Hyper: Grade 3/40 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Normal (at post baseline)1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)3 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Missing (at post baseline)1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to High (at post baseline)1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to High (at post baseline)3 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Missing (at post baseline)1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Normal (at post baseline)2 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Low (at post baseline)1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Missing (at post baseline)1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to High (at post baseline)1 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Normal (at post baseline)3 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Normal (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Normal (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Normal (at post baseline)4 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Low (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Low (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Low (at baseline) to Normal (at post baseline)1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to High (at post baseline)3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Low (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to High (at post baseline)1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to High (at post baseline)2 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: High (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: High (at baseline) to Normal (at post baseline)1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: High (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: High (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Normal (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Low (at post baseline)1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to High (at post baseline)1 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Normal (at post baseline)0 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Normal (at post baseline)2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Normal (at post baseline)6 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Missing (at post baseline)1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Normal (at post baseline)5 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Low (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Normal (at post baseline)1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Missing (at post baseline)1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Low (at post baseline)1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Normal (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to High (at post baseline)0 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Missing (at post baseline)1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Low (at post baseline)2 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)12 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Low (at baseline) to High (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Normal (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to High (at post baseline)2 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Low (at post baseline)3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to High (at post baseline)3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to High (at post baseline)1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to High (at post baseline)1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Missing (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to High (at post baseline)4 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Low (at baseline) to Missing (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Normal (at post baseline)1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Missing (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Low (at baseline) to Low (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to High (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Normal (at post baseline)14 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Low (at baseline) to Normal (at post baseline)1 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Normal (at post baseline)12 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Low (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Low (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Missing (at post baseline)0 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Normal (at post baseline)3 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to High (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Normal (at post baseline)12 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to High (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to High (at post baseline)5 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Normal (at post baseline)18 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Missing (at post baseline)5 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Low (at post baseline)4 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Low (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Normal (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to High (at post baseline)5 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Missing (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Low (at baseline) to Missing (at post baseline)1 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Low (at post baseline)3 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Low (at baseline) to High (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Normal (at post baseline)3 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Low (at baseline) to Normal (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)12 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to High (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Low (at baseline) to Low (at post baseline)2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Missing (at post baseline)3 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to High (at post baseline)2 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Normal (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Missing (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Low (at post baseline)0 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Missing (at post baseline)4 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Normal (at post baseline)5 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Normal (at post baseline)8 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to High (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Missing (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to High (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)7 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to High (at post baseline)5 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to High (at post baseline)2 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Missing (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Missing (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to High (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Normal (at post baseline)1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Low (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Low (at post baseline)4 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to High (at post baseline)1 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Low (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: High (at baseline) to Low (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: High (at baseline) to Normal (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesTriiodothyronine, Free: Low (at baseline) to Normal (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyroxine, Free: Normal (at baseline) to Missing (at post baseline)0 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline GradesThyrotropin: Normal (at baseline) to Missing (at post baseline)0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs6 Participants
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs3 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs6 Participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs1 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs6 Participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs3 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs19 Participants
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs8 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs27 Participants
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs15 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs10 Participants
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs5 Participants
Secondary

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.

ArmMeasureValue (MEDIAN)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)14.7 months
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)7.4 months
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)6.5 months
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)12.4 months
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)2.2 months
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)NA months
Secondary

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.

ArmMeasureValue (NUMBER)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 PembrolizumabPhase 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 PembrolizumabPhase 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 CohortPhase 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) CohortPhase 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) CohortPhase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR)0.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose542 nanogram per milliliterGeometric Coefficient of Variation 78.8
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 1 hr Post ARRY-382 dose1170 nanogram per milliliterGeometric Coefficient of Variation 76.5
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 4 Day 1 / Pre ARRY-382 dose405 nanogram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose1200 nanogram per milliliterGeometric Coefficient of Variation 57.6
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 5 Day 1 / Pre ARRY-382 doseNA nanogram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 8 hrs Post ARRY-382 dose384 nanogram per milliliterGeometric Coefficient of Variation 26.3
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose1530 nanogram per milliliterGeometric Coefficient of Variation 45.2
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 1 hr Post ARRY-382 dose283 nanogram per milliliterGeometric Coefficient of Variation 422
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / Pre ARRY-382 dose576 nanogram per milliliterGeometric Coefficient of Variation 59.5
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 3 Day 1 / Pre ARRY-382 dose565 nanogram per milliliterGeometric Coefficient of Variation 39.5
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 15 / Pre ARRY-382 dose616 nanogram per milliliterGeometric Coefficient of Variation 43
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose1100 nanogram per milliliterGeometric Coefficient of Variation 35.7
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 4 hrs Post ARRY-382 dose530 nanogram per milliliterGeometric Coefficient of Variation 37.9
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 1 hr Post ARRY-382 dose1310 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose1680 nanogram per milliliterGeometric Coefficient of Variation 8.22
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 3 Day 1 / Pre ARRY-382 dose305 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose497 nanogram per milliliterGeometric Coefficient of Variation 201
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose2030 nanogram per milliliterGeometric Coefficient of Variation 35.1
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 4 hrs Post ARRY-382 dose845 nanogram per milliliterGeometric Coefficient of Variation 49
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 1 hr Post ARRY-382 dose49.7 nanogram per milliliterGeometric Coefficient of Variation 1130
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 8 hrs Post ARRY-382 dose566 nanogram per milliliterGeometric Coefficient of Variation 28.8
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 15 / Pre ARRY-382 dose533 nanogram per milliliterGeometric Coefficient of Variation 34.2
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / Pre ARRY-382 dose762 nanogram per milliliterGeometric Coefficient of Variation 6.44
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose1600 nanogram per milliliterGeometric Coefficient of Variation 106
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose2120 nanogram per milliliterGeometric Coefficient of Variation 126
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose1440 nanogram per milliliterGeometric Coefficient of Variation 142
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 15 / Pre ARRY-382 dose888 nanogram per milliliter
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 1 hr Post ARRY-382 dose305 nanogram per milliliterGeometric Coefficient of Variation 263
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose2560 nanogram per milliliterGeometric Coefficient of Variation 117
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 1 hr Post ARRY-382 dose1430 nanogram per milliliterGeometric Coefficient of Variation 195
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose827 nanogram per milliliterGeometric Coefficient of Variation 64.2
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 8 hrs Post ARRY-382 dose757 nanogram per milliliterGeometric Coefficient of Variation 46.8
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 4 hrs Post ARRY-382 dose1130 nanogram per milliliterGeometric Coefficient of Variation 50
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / Pre ARRY-382 dose1040 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 9 Day 1 / Pre ARRY-382 dose350 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 1 hr Post ARRY-382 dose664 nanogram per milliliterGeometric Coefficient of Variation 194
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose1060 nanogram per milliliterGeometric Coefficient of Variation 65.8
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 4 hrs Post ARRY-382 dose1010 nanogram per milliliterGeometric Coefficient of Variation 44.7
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 8 hrs Post ARRY-382 dose683 nanogram per milliliterGeometric Coefficient of Variation 43.7
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 15 / Pre ARRY-382 dose862 nanogram per milliliterGeometric Coefficient of Variation 57.3
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 3 Day 1 / Pre ARRY-382 dose554 nanogram per milliliterGeometric Coefficient of Variation 70.3
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 4 Day 1 / Pre ARRY-382 dose1080 nanogram per milliliterGeometric Coefficient of Variation 119
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 6 Day 1 / Pre ARRY-382 dose798 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 10 Day 1 / Pre ARRY-382 dose244 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / Pre ARRY-382 dose330 nanogram per milliliterGeometric Coefficient of Variation 2050
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 1 hr Post ARRY-382 dose1320 nanogram per milliliterGeometric Coefficient of Variation 97.5
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose1830 nanogram per milliliterGeometric Coefficient of Variation 92.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose1630 nanogram per milliliterGeometric Coefficient of Variation 66.6
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose1530 nanogram per milliliterGeometric Coefficient of Variation 52.3
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 5 Day 1 / Pre ARRY-382 dose92.6 nanogram per milliliterGeometric Coefficient of Variation 13300
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 7 Day 1 / Pre ARRY-382 dose573 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 8 Day 1 / Pre ARRY-382 dose424 nanogram per milliliter
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose982 nanogram per milliliterGeometric Coefficient of Variation 101
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 5 Day 1 / Pre ARRY-382 dose1000 nanogram per milliliterGeometric Coefficient of Variation 35.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose2900 nanogram per milliliterGeometric Coefficient of Variation 4.73
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 3 Day 1 / Pre ARRY-382 dose324 nanogram per milliliterGeometric Coefficient of Variation 391
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 1 hr Post ARRY-382 dose373 nanogram per milliliterGeometric Coefficient of Variation 282
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 4 Day 1 / Pre ARRY-382 dose728 nanogram per milliliterGeometric Coefficient of Variation 85.2
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 1 hr Post ARRY-382 dose2000 nanogram per milliliterGeometric Coefficient of Variation 14.3
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 8 hrs Post ARRY-382 dose662 nanogram per milliliterGeometric Coefficient of Variation 76.7
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose3000 nanogram per milliliterGeometric Coefficient of Variation 9.01
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose2150 nanogram per milliliterGeometric Coefficient of Variation 7.22
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 6 Day 1 / Pre ARRY-382 dose1100 nanogram per milliliter
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / Pre ARRY-382 dose1550 nanogram per milliliterGeometric Coefficient of Variation 18.8
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 4 hrs Post ARRY-382 dose976 nanogram per milliliterGeometric Coefficient of Variation 72.6
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 15 / Pre ARRY-382 dose918 nanogram per milliliterGeometric Coefficient of Variation 79.1
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 1 hr Post ARRY-382 dose1220 nanogram per milliliterGeometric Coefficient of Variation 64.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 15 / Pre ARRY-382 dose485 nanogram per milliliterGeometric Coefficient of Variation 117
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 8 hrs Post ARRY-382 dose500 nanogram per milliliterGeometric Coefficient of Variation 52.6
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 1 hr Post ARRY-382 dose695 nanogram per milliliterGeometric Coefficient of Variation 145
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / Pre ARRY-382 dose438 nanogram per milliliterGeometric Coefficient of Variation 86.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day1 / 4 hrs Post ARRY-382 dose937 nanogram per milliliterGeometric Coefficient of Variation 54.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 3 Day 1 / Pre ARRY-382 dose336 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 7 Day 1 / Pre ARRY-382 dose505 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose1580 nanogram per milliliterGeometric Coefficient of Variation 79.6
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose1160 nanogram per milliliterGeometric Coefficient of Variation 57.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 4 Day 1 / Pre ARRY-382 dose522 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose1450 nanogram per milliliterGeometric Coefficient of Variation 62.7
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 5 Day 1 / Pre ARRY-382 dose76.6 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 6 Day 1 / Pre ARRY-382 dose518 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose973 nanogram per milliliterGeometric Coefficient of Variation 75.5
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 8 hrs Post ARRY-382 dose74.9 nanogram per milliliterGeometric Coefficient of Variation 85.3
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 1 hr Post ARRY-382 dose133 nanogram per milliliterGeometric Coefficient of Variation 72
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 1 hr Post ARRY-382 dose10.6 nanogram per milliliterGeometric Coefficient of Variation 750
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 5 Day 1 / Pre ARRY-382 doseNA nanogram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose210 nanogram per milliliterGeometric Coefficient of Variation 57.5
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 15 / Pre ARRY-382 dose136 nanogram per milliliterGeometric Coefficient of Variation 30.8
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose177 nanogram per milliliterGeometric Coefficient of Variation 89.6
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 3 Day 1 / Pre ARRY-382 dose121 nanogram per milliliterGeometric Coefficient of Variation 81.8
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose36.3 nanogram per milliliterGeometric Coefficient of Variation 219
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose166 nanogram per milliliterGeometric Coefficient of Variation 66
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / Pre ARRY-382 dose136 nanogram per milliliterGeometric Coefficient of Variation 67.7
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 4 hrs Post ARRY-382 dose69.5 nanogram per milliliterGeometric Coefficient of Variation 128
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 4 Day 1 / Pre ARRY-382 dose79.9 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 15 / Pre ARRY-382 dose73.7 nanogram per milliliterGeometric Coefficient of Variation 62.1
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 8 hrs Post ARRY-382 dose96.4 nanogram per milliliterGeometric Coefficient of Variation 62.9
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 4 hrs Post ARRY-382 dose83.6 nanogram per milliliterGeometric Coefficient of Variation 69.2
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 3 Day 1 / Pre ARRY-382 dose31.0 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / Pre ARRY-382 dose199 nanogram per milliliterGeometric Coefficient of Variation 82.5
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 1 hr Post ARRY-382 doseNA nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose320 nanogram per milliliterGeometric Coefficient of Variation 71.9
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 1 hr Post ARRY-382 dose245 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose208 nanogram per milliliterGeometric Coefficient of Variation 129
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose166 nanogram per milliliterGeometric Coefficient of Variation 133
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose19.6 nanogram per milliliterGeometric Coefficient of Variation 495
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 4 hrs Post ARRY-382 dose170 nanogram per milliliterGeometric Coefficient of Variation 72.6
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / Pre ARRY-382 dose188 nanogram per milliliter
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 1 hr Post ARRY-382 dose177 nanogram per milliliterGeometric Coefficient of Variation 94.7
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 1 hr Post ARRY-382 dose8.57 nanogram per milliliterGeometric Coefficient of Variation 404
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose57.2 nanogram per milliliterGeometric Coefficient of Variation 151
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 8 hrs Post ARRY-382 dose205 nanogram per milliliterGeometric Coefficient of Variation 88.7
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 15 / Pre ARRY-382 dose190 nanogram per milliliter
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose241 nanogram per milliliterGeometric Coefficient of Variation 73.8
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose305 nanogram per milliliterGeometric Coefficient of Variation 62
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose313 nanogram per milliliterGeometric Coefficient of Variation 77.8
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 5 Day 1 / Pre ARRY-382 dose11.5 nanogram per milliliterGeometric Coefficient of Variation 4020
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 8 hrs Post ARRY-382 dose119 nanogram per milliliterGeometric Coefficient of Variation 49.5
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 15 / Pre ARRY-382 dose210 nanogram per milliliterGeometric Coefficient of Variation 78.8
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 1 hr Post ARRY-382 dose254 nanogram per milliliterGeometric Coefficient of Variation 29.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 1 hr Post ARRY-382 dose21.0 nanogram per milliliterGeometric Coefficient of Variation 234
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 8 Day 1 / Pre ARRY-382 dose42.7 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose272 nanogram per milliliterGeometric Coefficient of Variation 36.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose298 nanogram per milliliterGeometric Coefficient of Variation 55.6
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 9 Day 1 / Pre ARRY-382 dose30.6 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / Pre ARRY-382 dose96.5 nanogram per milliliterGeometric Coefficient of Variation 2860
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 10 Day 1 / Pre ARRY-382 dose27.0 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose324 nanogram per milliliterGeometric Coefficient of Variation 44.1
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 3 Day 1 / Pre ARRY-382 dose123 nanogram per milliliterGeometric Coefficient of Variation 210
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 4 Day 1 / Pre ARRY-382 dose157 nanogram per milliliterGeometric Coefficient of Variation 228
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 7 Day 1 / Pre ARRY-382 dose61.5 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 6 Day 1 / Pre ARRY-382 dose86.9 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 4 hrs Post ARRY-382 dose110 nanogram per milliliterGeometric Coefficient of Variation 48.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose66.2 nanogram per milliliterGeometric Coefficient of Variation 80.5
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose510 nanogram per milliliterGeometric Coefficient of Variation 174
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 4 hrs Post ARRY-382 dose113 nanogram per milliliterGeometric Coefficient of Variation 109
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 6 Day 1 / Pre ARRY-382 dose141 nanogram per milliliter
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose561 nanogram per milliliterGeometric Coefficient of Variation 152
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 3 Day 1 / Pre ARRY-382 dose70.6 nanogram per milliliterGeometric Coefficient of Variation 243
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 8 hrs Post ARRY-382 dose132 nanogram per milliliterGeometric Coefficient of Variation 101
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 1 hr Post ARRY-382 dose7.95 nanogram per milliliterGeometric Coefficient of Variation 493
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 15 / Pre ARRY-382 dose250 nanogram per milliliterGeometric Coefficient of Variation 172
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / Pre ARRY-382 dose511 nanogram per milliliterGeometric Coefficient of Variation 189
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 1 hr Post ARRY-382 dose475 nanogram per milliliterGeometric Coefficient of Variation 173
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 4 Day 1 / Pre ARRY-382 dose138 nanogram per milliliterGeometric Coefficient of Variation 30
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose544 nanogram per milliliterGeometric Coefficient of Variation 168
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose54.7 nanogram per milliliterGeometric Coefficient of Variation 177
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 5 Day 1 / Pre ARRY-382 dose170 nanogram per milliliterGeometric Coefficient of Variation 10.4
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 4 Day 1 / Pre ARRY-382 dose70.3 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 7 Day 1 / Pre ARRY-382 dose103 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose157 nanogram per milliliterGeometric Coefficient of Variation 50.7
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 1 hr Post ARRY-382 dose102 nanogram per milliliterGeometric Coefficient of Variation 68.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 5 Day 1 / Pre ARRY-382 dose7.92 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 4 hrs Post ARRY-382 dose89.1 nanogram per milliliterGeometric Coefficient of Variation 39.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 1 hr Post ARRY-382 dose22.6 nanogram per milliliterGeometric Coefficient of Variation 164
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose133 nanogram per milliliterGeometric Coefficient of Variation 54.1
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose146 nanogram per milliliterGeometric Coefficient of Variation 58.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 15 / Pre ARRY-382 dose83.3 nanogram per milliliterGeometric Coefficient of Variation 132
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day1 / 8 hrs Post ARRY-382 dose75.7 nanogram per milliliterGeometric Coefficient of Variation 41.6
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 6 Day 1 / Pre ARRY-382 dose110 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 2 Day 1 / Pre ARRY-382 dose77.1 nanogram per milliliterGeometric Coefficient of Variation 85.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 3 Day 1 / Pre ARRY-382 dose54.0 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose60.8 nanogram per milliliterGeometric Coefficient of Variation 52.9
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / Pre ARRY-382 dose60.1 nanogram per milliliterGeometric Coefficient of Variation 103
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 4 Day 1 / Pre ARRY-382 dose31.1 nanogram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 4 hrs Post ARRY-382 dose41.7 nanogram per milliliterGeometric Coefficient of Variation 79.2
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose47.1 nanogram per milliliterGeometric Coefficient of Variation 109
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 1 hr Post ARRY-382 dose19.5 nanogram per milliliterGeometric Coefficient of Variation 667
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 5 Day 1 / Pre ARRY-382 doseNA nanogram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 8 hrs Post ARRY-382 dose28.2 nanogram per milliliterGeometric Coefficient of Variation 71.2
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 3 Day 1 / Pre ARRY-382 dose63.2 nanogram per milliliterGeometric Coefficient of Variation 108
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose104 nanogram per milliliterGeometric Coefficient of Variation 75.9
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose108 nanogram per milliliterGeometric Coefficient of Variation 108
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 15 / Pre ARRY-382 dose70.7 nanogram per milliliterGeometric Coefficient of Variation 81.2
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose138 nanogram per milliliterGeometric Coefficient of Variation 81.9
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 1 hr Post ARRY-382 dose105 nanogram per milliliterGeometric Coefficient of Variation 98.3
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 3 Day 1 / Pre ARRY-382 dose57.3 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / Pre ARRY-382 dose107 nanogram per milliliterGeometric Coefficient of Variation 45.5
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 1 hr Post ARRY-382 dose169 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose228 nanogram per milliliterGeometric Coefficient of Variation 39.5
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose210 nanogram per milliliterGeometric Coefficient of Variation 27.1
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 1 hr Post ARRY-382 doseNA nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose43.0 nanogram per milliliterGeometric Coefficient of Variation 468
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 4 hrs Post ARRY-382 dose82.7 nanogram per milliliterGeometric Coefficient of Variation 55.7
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 8 hrs Post ARRY-382 dose53.9 nanogram per milliliterGeometric Coefficient of Variation 42.5
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 15 / Pre ARRY-382 dose69.4 nanogram per milliliterGeometric Coefficient of Variation 24.5
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose196 nanogram per milliliterGeometric Coefficient of Variation 81.9
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose71.0 nanogram per milliliterGeometric Coefficient of Variation 96.9
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 1 hr Post ARRY-382 dose16.6 nanogram per milliliterGeometric Coefficient of Variation 584
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose161 nanogram per milliliterGeometric Coefficient of Variation 158
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 1 hr Post ARRY-382 dose138 nanogram per milliliterGeometric Coefficient of Variation 228
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / Pre ARRY-382 dose146 nanogram per milliliter
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose268 nanogram per milliliterGeometric Coefficient of Variation 141
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 8 hrs Post ARRY-382 dose67.7 nanogram per milliliterGeometric Coefficient of Variation 40.5
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 4 hrs Post ARRY-382 dose110 nanogram per milliliterGeometric Coefficient of Variation 40.5
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose219 nanogram per milliliterGeometric Coefficient of Variation 131
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 15 / Pre ARRY-382 dose116 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 1 hr Post ARRY-382 dose116 nanogram per milliliterGeometric Coefficient of Variation 75.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose165 nanogram per milliliterGeometric Coefficient of Variation 81.7
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose139 nanogram per milliliterGeometric Coefficient of Variation 57.4
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 8 hrs Post ARRY-382 dose65.4 nanogram per milliliterGeometric Coefficient of Variation 64.8
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 3 Day 1 / Pre ARRY-382 dose73.2 nanogram per milliliterGeometric Coefficient of Variation 73.5
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 4 Day 1 / Pre ARRY-382 dose108 nanogram per milliliterGeometric Coefficient of Variation 109
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 5 Day 1 / Pre ARRY-382 dose14.0 nanogram per milliliterGeometric Coefficient of Variation 6560
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 7 Day 1 / Pre ARRY-382 dose73.2 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 8 Day 1 / Pre ARRY-382 dose51.3 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 9 Day 1 / Pre ARRY-382 dose44.0 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 10 Day 1 / Pre ARRY-382 dose33.8 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 1 hr Post ARRY-382 dose61.0 nanogram per milliliterGeometric Coefficient of Variation 337
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose114 nanogram per milliliterGeometric Coefficient of Variation 69.1
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 4 hrs Post ARRY-382 dose102 nanogram per milliliterGeometric Coefficient of Variation 62
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 6 Day 1 / Pre ARRY-382 dose110 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose124 nanogram per milliliterGeometric Coefficient of Variation 39.5
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / Pre ARRY-382 dose35.2 nanogram per milliliterGeometric Coefficient of Variation 977
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 15 / Pre ARRY-382 dose106 nanogram per milliliterGeometric Coefficient of Variation 94.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose218 nanogram per milliliterGeometric Coefficient of Variation 74.8
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 4 hrs Post ARRY-382 dose85.5 nanogram per milliliterGeometric Coefficient of Variation 84.8
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose265 nanogram per milliliterGeometric Coefficient of Variation 65.5
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 4 Day 1 / Pre ARRY-382 dose75.5 nanogram per milliliterGeometric Coefficient of Variation 88.7
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose264 nanogram per milliliterGeometric Coefficient of Variation 75.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose81.9 nanogram per milliliterGeometric Coefficient of Variation 150
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 5 Day 1 / Pre ARRY-382 dose112 nanogram per milliliterGeometric Coefficient of Variation 46.2
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 8 hrs Post ARRY-382 dose56.4 nanogram per milliliterGeometric Coefficient of Variation 83.3
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 1 hr Post ARRY-382 dose21.3 nanogram per milliliterGeometric Coefficient of Variation 553
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 3 Day 1 / Pre ARRY-382 dose54.8 nanogram per milliliterGeometric Coefficient of Variation 255
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / Pre ARRY-382 dose184 nanogram per milliliterGeometric Coefficient of Variation 91.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 1 hr Post ARRY-382 dose191 nanogram per milliliterGeometric Coefficient of Variation 92.5
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 6 Day 1 / Pre ARRY-382 dose148 nanogram per milliliter
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 15 / Pre ARRY-382 dose96.0 nanogram per milliliterGeometric Coefficient of Variation 85.3
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 3 Day 1 / Pre ARRY-382 dose32.7 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 7 Day 1 / Pre ARRY-382 dose67.4 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 8 hrs Post ARRY-382 dose44.0 nanogram per milliliterGeometric Coefficient of Variation 50.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose164 nanogram per milliliterGeometric Coefficient of Variation 67.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 15 / Pre ARRY-382 dose60.8 nanogram per milliliterGeometric Coefficient of Variation 121
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 5 Day 1 / Pre ARRY-382 dose11.7 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 6 Day 1 / Pre ARRY-382 dose72.8 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 1 hr Post ARRY-382 dose173 nanogram per milliliterGeometric Coefficient of Variation 39.1
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose226 nanogram per milliliterGeometric Coefficient of Variation 66.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose123 nanogram per milliliterGeometric Coefficient of Variation 51.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day 1 / 1 hr Post ARRY-382 dose75.4 nanogram per milliliterGeometric Coefficient of Variation 131
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 4 Day 1 / Pre ARRY-382 dose67.6 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose107 nanogram per milliliterGeometric Coefficient of Variation 77.8
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 2 Day 1 / Pre ARRY-382 dose57.1 nanogram per milliliterGeometric Coefficient of Variation 99.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100Cycle 1 Day1 / 4 hrs Post ARRY-382 dose101 nanogram per milliliterGeometric Coefficient of Variation 46.8
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / Pre ARRY-382 dose99.1 nanogram per milliliterGeometric Coefficient of Variation 80.8
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 4 Day 1 / Pre ARRY-382 dose77.4 nanogram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose165 nanogram per milliliterGeometric Coefficient of Variation 49.3
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose149 nanogram per milliliterGeometric Coefficient of Variation 54.4
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 1 hr Post ARRY-382 dose122 nanogram per milliliterGeometric Coefficient of Variation 63.9
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 4 hrs Post ARRY-382 dose64.5 nanogram per milliliterGeometric Coefficient of Variation 101
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 1 hr Post ARRY-382 dose14.6 nanogram per milliliterGeometric Coefficient of Variation 835
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose49.4 nanogram per milliliterGeometric Coefficient of Variation 193
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 8 hrs Post ARRY-382 dose53.7 nanogram per milliliterGeometric Coefficient of Variation 78.4
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose151 nanogram per milliliterGeometric Coefficient of Variation 58.9
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 5 Day 1 / Pre ARRY-382 doseNA nanogram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 15 / Pre ARRY-382 dose105 nanogram per milliliterGeometric Coefficient of Variation 86.9
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 3 Day 1 / Pre ARRY-382 dose118 nanogram per milliliterGeometric Coefficient of Variation 88.7
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / Pre ARRY-382 dose294 nanogram per milliliterGeometric Coefficient of Variation 49.3
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose36.7 nanogram per milliliterGeometric Coefficient of Variation 2940
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose460 nanogram per milliliterGeometric Coefficient of Variation 37.6
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 1 hr Post ARRY-382 doseNA nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 3 Day 1 / Pre ARRY-382 dose250 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 4 hrs Post ARRY-382 dose159 nanogram per milliliterGeometric Coefficient of Variation 106
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose444 nanogram per milliliterGeometric Coefficient of Variation 29
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose503 nanogram per milliliterGeometric Coefficient of Variation 26.8
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 15 / Pre ARRY-382 dose255 nanogram per milliliterGeometric Coefficient of Variation 11
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 1 hr Post ARRY-382 dose377 nanogram per milliliter
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 8 hrs Post ARRY-382 dose144 nanogram per milliliterGeometric Coefficient of Variation 71.3
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 1 hr Post ARRY-382 dose206 nanogram per milliliterGeometric Coefficient of Variation 68.5
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose327 nanogram per milliliterGeometric Coefficient of Variation 61.2
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose68.7 nanogram per milliliterGeometric Coefficient of Variation 113
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 1 hr Post ARRY-382 dose11.7 nanogram per milliliterGeometric Coefficient of Variation 410
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 4 hrs Post ARRY-382 dose182 nanogram per milliliterGeometric Coefficient of Variation 73.7
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 8 hrs Post ARRY-382 dose162 nanogram per milliliterGeometric Coefficient of Variation 52.6
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 15 / Pre ARRY-382 dose231 nanogram per milliliter
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / Pre ARRY-382 dose216 nanogram per milliliter
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose283 nanogram per milliliterGeometric Coefficient of Variation 68.8
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose306 nanogram per milliliterGeometric Coefficient of Variation 47.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / Pre ARRY-382 dose83.4 nanogram per milliliterGeometric Coefficient of Variation 2600
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 1 hr Post ARRY-382 dose46.9 nanogram per milliliterGeometric Coefficient of Variation 403
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose140 nanogram per milliliterGeometric Coefficient of Variation 97.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 8 hrs Post ARRY-382 dose150 nanogram per milliliterGeometric Coefficient of Variation 56.8
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 1 hr Post ARRY-382 dose244 nanogram per milliliterGeometric Coefficient of Variation 58.1
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose337 nanogram per milliliterGeometric Coefficient of Variation 70.2
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose320 nanogram per milliliterGeometric Coefficient of Variation 65.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose337 nanogram per milliliterGeometric Coefficient of Variation 55.3
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 3 Day 1 / Pre ARRY-382 dose156 nanogram per milliliterGeometric Coefficient of Variation 87
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 6 Day 1 / Pre ARRY-382 dose73.5 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 8 Day 1 / Pre ARRY-382 dose62.8 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 9 Day 1 / Pre ARRY-382 dose73.8 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 10 Day 1 / Pre ARRY-382 dose90.6 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 4 Day 1 / Pre ARRY-382 dose161 nanogram per milliliterGeometric Coefficient of Variation 113
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 5 Day 1 / Pre ARRY-382 dose16.4 nanogram per milliliterGeometric Coefficient of Variation 10600
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 7 Day 1 / Pre ARRY-382 dose60.7 nanogram per milliliter
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 4 hrs Post ARRY-382 dose191 nanogram per milliliterGeometric Coefficient of Variation 59.9
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 15 / Pre ARRY-382 dose259 nanogram per milliliterGeometric Coefficient of Variation 49.3
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 1 hr Post ARRY-382 dose12.6 nanogram per milliliterGeometric Coefficient of Variation 1100
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 15 / Pre ARRY-382 dose307 nanogram per milliliterGeometric Coefficient of Variation 74
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose348 nanogram per milliliterGeometric Coefficient of Variation 40.3
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 5 Day 1 / Pre ARRY-382 dose268 nanogram per milliliterGeometric Coefficient of Variation 18.2
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 4 hrs Post ARRY-382 dose129 nanogram per milliliterGeometric Coefficient of Variation 116
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose345 nanogram per milliliterGeometric Coefficient of Variation 36.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose310 nanogram per milliliterGeometric Coefficient of Variation 47.2
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / Pre ARRY-382 dose285 nanogram per milliliterGeometric Coefficient of Variation 58.4
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 4 Day 1 / Pre ARRY-382 dose263 nanogram per milliliterGeometric Coefficient of Variation 13.5
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 8 hrs Post ARRY-382 dose123 nanogram per milliliterGeometric Coefficient of Variation 90.1
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 6 Day 1 / Pre ARRY-382 dose419 nanogram per milliliter
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 3 Day 1 / Pre ARRY-382 dose194 nanogram per milliliterGeometric Coefficient of Variation 65
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 1 hr Post ARRY-382 dose279 nanogram per milliliterGeometric Coefficient of Variation 53.8
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose74.8 nanogram per milliliterGeometric Coefficient of Variation 277
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose189 nanogram per milliliterGeometric Coefficient of Variation 59.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose401 nanogram per milliliterGeometric Coefficient of Variation 19.2
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 3 Day 1 / Pre ARRY-382 dose194 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 4 Day 1 / Pre ARRY-382 dose158 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 8 hrs Post ARRY-382 dose148 nanogram per milliliterGeometric Coefficient of Variation 46.7
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 6 Day 1 / Pre ARRY-382 dose192 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose486 nanogram per milliliterGeometric Coefficient of Variation 18.9
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day1 / 4 hrs Post ARRY-382 dose220 nanogram per milliliterGeometric Coefficient of Variation 46.9
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 1 / 1 hr Post ARRY-382 dose71.7 nanogram per milliliterGeometric Coefficient of Variation 125
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 1 Day 15 / Pre ARRY-382 dose242 nanogram per milliliterGeometric Coefficient of Variation 33.5
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose462 nanogram per milliliterGeometric Coefficient of Variation 16.9
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / 1 hr Post ARRY-382 dose316 nanogram per milliliterGeometric Coefficient of Variation 26.4
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 5 Day 1 / Pre ARRY-382 dose33.8 nanogram per milliliter
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 2 Day 1 / Pre ARRY-382 dose224 nanogram per milliliterGeometric Coefficient of Variation 34.1
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870Cycle 7 Day 1 / Pre ARRY-382 dose236 nanogram per milliliter
Secondary

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.

ArmMeasureValue (MEDIAN)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 PembrolizumabPhase 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 PembrolizumabPhase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)1.4 months
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)1.6 months
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)1.4 months
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)2.1 months
Secondary

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.

ArmMeasureGroupValue (MEDIAN)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004691002.00 hours
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3822.00 hours
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3822.00 hours
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004708703.00 hours
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004691002.00 hours
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004690997.94 hours
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004708703.00 hours
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004690997.98 hours
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004708704.03 hours
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004690997.68 hours
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3824.01 hours
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3824.18 hours
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004691002.98 hours
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004690997.81 hours
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004708704.18 hours
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004691003.03 hours
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004691004.07 hours
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004690997.95 hours
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004690998.00 hours
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3824.07 hours
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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-3821.98 hours
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004691001.98 hours
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004708704.07 hours
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 AR004708708.00 hours
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR004690997.50 hours
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR004708704.03 hours
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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-3822.00 hours
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR004708704.00 hours
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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-3821.97 hours
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR004691001.98 hours
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR004690995.88 hours
Phase 2: PD-1/PD-L1 Inhibitor-Refractory CohortPhase 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 AR004691002.00 hours
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR004690995.83 hours
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR004691003.90 hours
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR004690995.90 hours
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR004691002.00 hours
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR004708705.78 hours
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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 AR004708704.07 hours
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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-3822.00 hours
Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) CohortPhase 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-3823.03 hours
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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-3822.00 hours
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR004691002.00 hours
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR004690994.05 hours
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR004690994.17 hours
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR004708704.05 hours
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR004691002.00 hours
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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-3822.00 hours
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) CohortPhase 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 AR004708703.80 hours
Secondary

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.

ArmMeasureValue (NUMBER)
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A: Objective Response Rate (ORR)16.7 percentage of participants
Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A: Objective Response Rate (ORR)16.7 percentage of participants
Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 1b, Part A: Objective Response Rate (ORR)0.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 1 Day 1578.6 microgram per milliliterStandard Deviation 626.3302643
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 1 Day 8803.3181818 microgram per milliliterStandard Deviation 808.9155788
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 1 Day 151279.833333 microgram per milliliterStandard Deviation 1298.144638
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 2 Day 11485.6 microgram per milliliterStandard Deviation 1368.310653
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 3 Day 11558.4 microgram per milliliterStandard Deviation 1502.22728
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 4 Day 11980 microgram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 5 Day 1778 microgram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 6 Day 11730 microgram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationCycle 7 Day 12080 microgram per milliliter
Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg PembrolizumabPhase 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 DiscontinuationTreatment discontinuation1743.833333 microgram per milliliterStandard Deviation 1817.18193

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026