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
• Sponsor: Synta Pharmaceuticals Corp.
• Information provided by (Responsible Party): Synta Pharmaceuticals Corp.

Tracking Information

• First Submitted Date: May 2, 2011
• First Posted Date: May 5, 2011
• Last Update Posted Date: November 5, 2015
• Study Start Date: May 2011
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 2, 2012): Progression-free survival in two co-primary populations [ Time Frame: 14 months ]

Original Primary Outcome Measures (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 (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 (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer
• 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
• 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 4, 2015): 385
• Original Estimated Enrollment (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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Bosnia and Herzegovina, Canada, Croatia, Czech Republic, Germany, Poland, Romania, Russian Federation, Serbia, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT01348126
• Other Study ID Numbers: 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: Synta Pharmaceuticals Corp.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Synta Pharmaceuticals Corp.
• Verification Date: November 2015