drugset / Trial / NCT01798485

A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC

NCT01798485 ↗

Phase 3 Terminated 696 enrolled Synta Pharmaceuticals Corp.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

Timeline

Start
2013-04
Primary completion
2015-12
Completion
2015-12

Outcome

Missed primary endpoint

Stopped: “The study was stopped after the first Interim Analysis due to futility.”

registry MEDIAN Ganetespib and Docetaxel: 10.9 (9.0 to 12.3) months NCT01798485 ↗

registry analysis (superiority or other test); Ganetespib and Docetaxel vs Docetaxel; p = 0.3293; Hazard Ratio (HR) 1.111 (95% CI 0.899 to 1.372); Log Rank NCT01798485 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Ganetespib Small molecule 150 mg/m2 Intravenous

Indications