drugset / Trial / NCT01497964

Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy

NCT01497964

Phase 1/2 Completed 16 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2011-12
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified Intravenous

Indications