Protocol #: 16-399
Status
Active, not recruiting
Description
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).
Condition
Advanced Solid Tumors
Interventions
ARRY-382
Pembrolizumab
Phase
Phase 1/Phase 2
Study Type
Interventional
Further Study Details
Primary Outcome:
(Phase 1b/Part A) Incidence of dose-limiting toxicities (DLTs)
(Phase 2) Efficacy of the combination in terms of the objective response rate (ORR)
Secondary Outcome:
(Phase 1b/Part A) Preliminary antitumor activity of the combination in terms of objective response rate (ORR)
(Phase 1b/Part A, Phase 2) Duration of response (DOR)
(Phase 1b/Part A, Phase 2) Progression-free survival (PFS)
(Phase 1b/Part A, Phase 2) Overall survival (OS)
(Phase 1b/Part A, Phase 2) Immune-related response criteria (irRR)
(Phase 1b/Part A, Phase 2) Immune-related progression-free survival (irPFS)
(Phase 1b/Part A, Phase 2) Evaluation of the plasma concentration-time profiles of ARRY-382 and its metabolites in the combination
(Phase 1b/Part A, Phase 2) Safety and tolerability of the combination in terms of adverse events and serious adverse events
(Phase 1b/Part A, Phase 2) Trough concentrations and pharmacokinetics (AUC, Cmax, Tmax, accumulation ratio and metabolite-to-parent ratio) for ARRY-382 and its three metabolites
Estimated Enrollment
90
Study Start Date
August 2016
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Array BioPharma
Information Provided By
Array BioPharma
Official Title
A 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
Clinicaltrials.gov Identifier
NCT02880371

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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