NCT01798485

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

A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 696 (actual)
• Sponsor: Synta Pharmaceuticals Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival (OS) has been observed. Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility. The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.

Conditions

• Non-Small-Cell Lung Adenocarcinoma
• Non-small Cell Lung Cancer Stage IIIB
• Non-small Cell Lung Cancer Stage IV
• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel, 75 mg/m\^2, was administered according to prevailing practice and Investigator decision, generally until disease progression, intolerability, or patient's withdrawal of consent.
DRUG	Ganetespib	Ganetespib, 150 mg/m\^2, was administered with docetaxel. After docetaxel treatment ceased, participants whose disease has not progressed continued to receive ganetespib alone until disease progression, unacceptable toxicity, or patient's withdrawal of consent.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-02-25
• Last updated: 2016-07-01
• Results posted: 2016-07-01

Locations

267 sites across 20 countries: United States, Austria, Belgium, Bosnia and Herzegovina, Canada, Croatia, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russia, Serbia, Slovenia, Spain, Ukraine, United Kingdom