A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Document progression free survival after treatment with ARQ 501 and gemcitabine
United States: Food and Drug Administration
ARQ 501-212
NCT00102700
January 2005
January 2007
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Jacobi Medical Center | Bronx, New York 10461 |
Scripps Cancer Center | La Jolla, California 92037 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
University of Kentucky Medical Center | Lexington, Kentucky 40536-0093 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage, California 92270 |
VA San Diego Healthcare System | San Diego, California 92161 |
University of South Alabama | Mobile, Alabama 36693 |
Unversity of Kentucky Medical Center - Markey Center | Lexington, Kentucky 40536 |
The Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |
Jeffrey Meyerhardt | Boston, Massachusetts 02115 |