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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01348126
First received: May 2, 2011
Last updated: May 13, 2013
Last verified: June 2012

May 2, 2011
May 13, 2013
May 2011
September 2013   (final data collection date for primary outcome measure)
Progression-free survival in two co-primary populations [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Estimated median OS of 8 months in the ganetespib treatment arm and 4 months in docetaxel alone arm
Complete list of historical versions of study NCT01348126 on ClinicalTrials.gov Archive Site
  • Overall Response Rate [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    ORR is the proportion of subjects who achieve tumor response
  • Determine qualitative and quantitative toxicities [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Assessed via measurement of Cmax levels.
  • Evaluate Quality of Life [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    As measured by the EORTC QLQ -C30 questionnaire
  • Disease Control Rate [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Tumor size changes from baseline to at least 6 and 12 weeks
  • Overall survival [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    ORR is the proportion of subjects who achieve tumor response
  • Determine qualitative and quantitative toxicities [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Assessed via measurement of Cmax levels.
  • Evaluate Quality of Life [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    As measured by the EORTC QLQ -C30 questionnaire
  • Clinical Benefit Rate [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean tumor size changes from baseline to at least 6 and 12 weeks
Not Provided
Not Provided
 
Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-small Cell Lung Cancer Stage IIIB
  • Non-small Cell Lung Cancer Stage IV
  • Non-small Cell Lung Cancer Metastatic
  • 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.
  • Active Comparator: Single agent docetaxel
    Intervention: Drug: Docetaxel
  • Experimental: Combination of ganetespib and docetaxel
    Intervention: Drug: Combination of ganetespib and docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
March 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Bosnia and Herzegovina,   Canada,   Croatia,   Czech Republic,   Germany,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   United Kingdom
 
NCT01348126
9090-08
No
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP