Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer (GALAXY)
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ClinicalTrials.gov Identifier: NCT01348126 |
Recruitment Status
:
Terminated
First Posted
: May 5, 2011
Last Update Posted
: November 5, 2015
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Sponsor:
Synta Pharmaceuticals Corp.
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
Tracking Information | |||
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First Submitted Date ICMJE | May 2, 2011 | ||
First Posted Date ICMJE | May 5, 2011 | ||
Last Update Posted Date | November 5, 2015 | ||
Study Start Date ICMJE | May 2011 | ||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Progression-free survival in two co-primary populations [ Time Frame: 14 months ] | ||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01348126 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer | ||
Official Title ICMJE | 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 | ||
Brief 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. | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
385 | ||
Original Estimated Enrollment ICMJE |
240 | ||
Actual Study Completion Date | October 2015 | ||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Belgium, Bosnia and Herzegovina, Canada, Croatia, Czech Republic, Germany, Poland, Romania, Russian Federation, Serbia, Spain, United Kingdom, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01348126 | ||
Other Study ID Numbers ICMJE | 9090-08 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Synta Pharmaceuticals Corp. | ||
Study Sponsor ICMJE | Synta Pharmaceuticals Corp. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Synta Pharmaceuticals Corp. | ||
Verification Date | November 2015 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |