Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To demonstrate progression free survival (PFS) improvement for ombrabulin compared to
placebo, in combination with taxane and platinum, as first line treatment for patients
with metastatic non-small cell lung cancer (NSCLC).
Secondary Objective:
- To determine overall survival (OS), overall response rate (ORR) according to Response
Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential
biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite,
RPR258063, using a population approach.