drugset / Trial / NCT00806286

Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

NCT00806286

Phase 2 Completed 111 enrolled Daiichi Sankyo
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.

Timeline

Start
2008-12
Primary completion
2012-01
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject efatutazone Small molecule 0.5 mg
Background Carboplatin Small molecule 6 unknown
Background Paclitaxel Small molecule 200 mg/m2 Intravenous