Spots Global Cancer Trial Database for A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors
Official Title: 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
Study ID: NCT02880371
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
UCLA Hematology/Oncology, Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
University of Colorado Denver, Aurora, Colorado, United States
University of Colorado Hospital, Aurora, Colorado, United States
Hem-Onc Associates of Treasure Coast, Port Saint Lucie, Florida, United States
Parkview Cancer Institute, Fort Wayne, Indiana, United States
Parkview Regional Medical Center, Fort Wayne, Indiana, United States
Parkview Research Center, Fort Wayne, Indiana, United States
PPG, Fort Wayne, Indiana, United States
Horizon Oncology Research, Inc., Lafayette, Indiana, United States
Hall-Perrine Cancer Center Laboratory, Cedar Rapids, Iowa, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic Labs - Rochester Superior, Rochester, Minnesota, United States
Regions Cancer Care Center, Saint Paul, Minnesota, United States
Regions Hospital Pharmacy, Saint Paul, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
HealthPartners Neurosciences Center, Saint Paul, Minnesota, United States
Tennessee Oncology PLLC, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The Sarah Cannon Research Institute, Nashville, Tennessee, United States
UT Health Cancer Center, San Antonio, Texas, United States
UTAH Cancer Specialists, Salt Lake City, Utah, United States
ARUP Laboratories, Inc., Salt Lake City, Utah, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
UVA Health System, Charlottesville, Virginia, United States
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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