A Study of ARQ 197 Versus Investigator's Choice of Second-Line Chemotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Chemotherapy Regimen

• Status: Withdrawn
• Trial end date: 1969-12-31

Summary

This will be a multi-center, open-label randomized phase 2 study designed to evaluate the progression free survival (PFS) of patients with advanced gastric cancer following treatment with either ARQ 197 or one of three standard regimens (investigator's choice). Patients with unresectable (locally advanced or metastatic) gastric carcinoma who have progressive neoplastic disease following treatment with a prior regimen consisting of at least two of the drugs 5-FU, cisplatin and docetaxel. The study will also evaluate other efficacy and safety parameters including overall response rate, overall survival and adverse events in the two treatment arms.

• Phase: Phase 2

Details

• Lead Sponsor: ArQule; ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
• Treatments: Capecitabine; Irinotecan; Oxaliplatin