Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer (GALAXY)

Tracking Information
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; (submitted: May 2, 2012)	Progression-free survival in two co-primary populations [ Time Frame: 14 months ]
Original Primary Outcome Measures ICMJE; (submitted: May 3, 2011)	Progression free survival [ Time Frame: 14 months ]Estimated median PFS of 4.5 months in the ganetespib treatment arm and 3 months in docetaxel alone arm; Overall survival in a subset of subjects with high baseline serum LDH [ Time Frame: 21 months ]Estimated median OS of 8 months in the ganetespib treatment arm and 4 months in docetaxel alone arm
Change History	Complete list of historical versions of study NCT01348126 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 2, 2012)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: May 3, 2011)	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; Clinical Benefit Rate [ Time Frame: 14 months ]Clinical Benefit Rate is defined as best response of CR, PR and SD disease for at least 6 or 12 weeks; Mean tumor size change [ Time Frame: 14 months ]Mean tumor size changes from baseline to at least 6 and 12 weeks
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
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic
Intervention ICMJE	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.
Study Arms	Active Comparator: Single agent docetaxel Intervention: Drug: Docetaxel; Experimental: Combination of ganetespib and docetaxel Intervention: Drug: Combination of ganetespib and docetaxel
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: November 4, 2015)	385
Original Estimated Enrollment ICMJE; (submitted: May 3, 2011)	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: confirmed diagnosis of NSCLC; Stage IIIB or IV NSCLC; ECOG Performance Status 0 or 1; Prior therapy defined as 1 prior systemic therapy for advanced disease; measurable disease; Radiologic evidence of disease progression following most recent prior treatment.; Adequate hematologic, hepatic, renal function Exclusion Criteria: Active or untreated CNS metastases; Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin; Serious cardiac illness or medical conditions; Pregnant or lactating women; Uncontrolled intercurrent illness
Sex/Gender	Sexes Eligible for Study: All
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