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

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Single agent docetaxel Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival in two co-primary populations [ Time Frame: 14 months ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 14 months ]
    ORR is the proportion of subjects who achieve tumor response

  2. 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.

  3. Determine plasma drug concentrations of the combination [ Time Frame: 14 months ]
    Assessed via measurement of Cmax levels.

  4. Evaluate Quality of Life [ Time Frame: 14 months ]
    As measured by the EORTC QLQ -C30 questionnaire

  5. 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.

  6. Tumor size change [ Time Frame: 14 months ]
    Tumor size changes from baseline to at least 6 and 12 weeks

  7. Overall survival [ Time Frame: 21 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348126


Locations
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Sponsors and Collaborators
Synta Pharmaceuticals Corp.
More Information
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Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01348126    
Other Study ID Numbers: 9090-08
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015
Keywords provided by Synta Pharmaceuticals Corp.:
Advanced non-small cell lung cancer
NSCLC
Lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action