Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
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
Outcome
Missed primary endpoint
registry NUMBER CS7017+Carboplatin+Paclitaxel: 40.2 (25.7 to 54.2) percentage of participants NCT00806286 ↗
registry NUMBER CS7017-matching Placebo+Carboplatin+Paclitaxel: 63.3 (48.7 to 74.9) percentage of participants NCT00806286 ↗
registry analysis (superiority test); CS7017+Carboplatin+Paclitaxel vs CS7017-matching Placebo+Carboplatin+Paclitaxel; p <0.0001; Mean Difference (Final Values) -23.2; Z-test NCT00806286 ↗
registry NUMBER CS7017+Carboplatin+Paclitaxel: 37.9 (23.5 to 52.1) percentage of participants NCT00806286 ↗
registry analysis (superiority test); CS7017+Carboplatin+Paclitaxel vs CS7017-matching Placebo+Carboplatin+Paclitaxel; p <0.0001; Mean Difference (Final Values) -25.5; Z-test NCT00806286 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | efatutazone | Small molecule | 0.5 mg | — |
| Background | Carboplatin | Small molecule | 6 unknown | — |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |