NCT00102700

ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (planned)
• Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Cancer
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ARQ 501 in combination with gemcitabine

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-02-02
• Last updated: 2009-04-29

Locations

15 sites across 1 country: United States