Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer (GALAXY)
|ClinicalTrials.gov Identifier: NCT01348126|
Recruitment Status : Terminated
First Posted : May 5, 2011
Last Update Posted : November 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Metastatic||Drug: Docetaxel Drug: Combination of ganetespib and docetaxel||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||385 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2011|
|Primary Completion Date :||April 2014|
|Study Completion Date :||October 2015|
|Active Comparator: Single agent docetaxel||
75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion
|Experimental: Combination of ganetespib and docetaxel||
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.
- Progression-free survival in two co-primary populations [ Time Frame: 14 months ]
- Overall Response Rate [ Time Frame: 14 months ]ORR is the proportion of subjects who achieve tumor response
- Determine qualitative and quantitative toxicities [ Time Frame: 14 months ]AEs will be graded by NCI-CTC criteria. Tabulations of adverse events by frequency, relatedness and severity will be presented. Data will be presented by treatment arm and overall. No formal statistical analyses are planned.
- Determine plasma drug concentrations of the combination [ Time Frame: 14 months ]Assessed via measurement of Cmax levels.
- Evaluate Quality of Life [ Time Frame: 14 months ]As measured by the EORTC QLQ -C30 questionnaire
- Disease Control Rate [ Time Frame: 14 months ]Disease Control Rate is defined as the proportion of patients with best response, according to modified RECIST 1.1, of CR, PR or SD, where the SD must be for at least 6 weeks or 12 weeks.
- Tumor size change [ Time Frame: 14 months ]Tumor size changes from baseline to at least 6 and 12 weeks
- Overall survival [ Time Frame: 21 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348126
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