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
18 Years
N/A
Both
Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Metastatic
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival in two co-primary populations
Outcome Time Frame:
14 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
9090-08
NCT ID:
NCT01348126
Start Date:
May 2011
Completion Date:
March 2014
Related Keywords:
- Non-small Cell Lung Cancer Stage IIIB
- Non-small Cell Lung Cancer Stage IV
- Non-small Cell Lung Cancer Metastatic
- Advanced non-small cell lung cancer
- NSCLC
- Lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Synta Pharmaceuticals Investigative Site | Tucson, Arizona 85715 |
| Synta Pharmaceuticals Investigative Site | Santa Monica, California 90404 |
| Synta Pharmaceuticals Investigative Site | Atlanta, Georgia 30322 |
| Synta Pharmaceuticals Investigative Site | Chicago, Illinois 60637 |
| Synta Pharmaceutials Investigative Site | Boston, Massachusetts 02215 |
| Synta Pharmaceuticals Investigative Site | Winston-Salem, North Carolina 27103 |
| Synta Pharmaceuticals Investigative Site | Kettering, Ohio 45429 |
| Synta Pharmaceuticals Investigative Site | Portland, Oregon 97227 |
