Trial Information

Official Title: A Phase 2, Multicenter Study of Cabazitaxel Single Agent Administered as a 1-Hour Intravenous Infusion Every 3 Weeks to Evaluate the Safety, Tolerability and Anti-tumor Activity of Cabazitaxel in Patients With Advanced Gastric Adenocarcinoma Who Have Failed Prior Chemotherapy Regimens

Summary

Primary Objective: - To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens Secondary Objectives: - To determine the RD of cabazitaxel when administered as a single agent every 3 weeks - To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks - To estimate the overall survival (OS) and progression free survival (PFS) - To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1

Phase: Phase 1

Sponsor: Sanofi

Overall Contacts:

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