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Brief Title: ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
Official Title: A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Study ID: NCT00102700
Brief Summary: The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.
Detailed Description: This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. The study objectives are: Primary Objective: * Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine. Secondary Objectives: * Determine time to tumor progression (TTP) of patients treated with ARQ 501 in combination with gemcitabine * Further characterize the safety of ARQ 501 in combination with gemcitabine
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of South Alabama, Mobile, Alabama, United States
Moores UCSD Cancer Center, La Jolla, California, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
Scripps Cancer Center, San Diego, California, United States
VA San Diego Healthcare System, San Diego, California, United States
University of Chicago Medical Center, Chicago, Illinois, United States
University of Kentucky Medical Center, Lexington, Kentucky, United States
Unversity of Kentucky Medical Center - Markey Center, Lexington, Kentucky, United States
The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Jeffrey Meyerhardt, Boston, Massachusetts, United States
Jacobi Medical Center, Bronx, New York, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Baylor College of Medicine, Houston, Texas, United States
Virginia Cancer Institute, Richmond, Virginia, United States