Trials / Terminated
TerminatedNCT01348126
Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer
A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 385 (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 subjects with advanced non-small cell lung cancer.
Detailed description
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.
Conditions
- 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 | 75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion |
| DRUG | Combination of ganetespib and docetaxel | Ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle. |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2014-04-01
- Completion
- 2015-10-01
- First posted
- 2011-05-05
- Last updated
- 2015-11-05
Locations
53 sites across 13 countries: United States, Belgium, Bosnia and Herzegovina, Canada, Croatia, Czechia, Germany, Poland, Romania, Russia, Serbia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01348126. Inclusion in this directory is not an endorsement.