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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Metastatic

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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 SiteTucson, Arizona  85715
Synta Pharmaceuticals Investigative SiteSanta Monica, California  90404
Synta Pharmaceuticals Investigative SiteAtlanta, Georgia  30322
Synta Pharmaceuticals Investigative SiteChicago, Illinois  60637
Synta Pharmaceutials Investigative SiteBoston, Massachusetts  02215
Synta Pharmaceuticals Investigative SiteWinston-Salem, North Carolina  27103
Synta Pharmaceuticals Investigative SiteKettering, Ohio  45429
Synta Pharmaceuticals Investigative SitePortland, Oregon  97227