drugset / Trial / NCT00290953

Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide

NCT00290953 ↗

Phase 2/3 Completed 432 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR48692 versus placebo, after an initial response (complete or partial response or stable) to first line cisplatin plus etoposide. Primary objective: comparison of overall survival between patients in the control arm and the meclinertant arm. Secondary objectives: comparison of the progression free survival, the time to progression, the clinical benefit, the quality of life, the toxicity and safety between patients in the control arm and the meclinertant arm.

Timeline

Start
2002-10
Primary completion
2006-03
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Subject REMINERTANT Small molecule — —