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2N-12-2-Protocol 9090-08: 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

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.

Phase

Phase 2/3 - for trials that are a combination of phases 2 and 3.

Inclusion and Exclusion 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

  • 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

Sites

  • California

    • Synta Pharmaceuticals Investigative Site, Santa Monica, California, 90404
  • Arizona

    • Synta Pharmaceuticals Investigative Site, Tucson, Arizona, 85715
  • Oregon

    • Synta Pharmaceuticals Investigative Site, Portland, Oregon, 97227
  • Illinois

    • Synta Pharmaceuticals Investigative Site, Chicago, Illinois, 60637
  • Ohio

    • Synta Pharmaceuticals Investigative Site, Kettering, Ohio, 45429
  • Georgia

    • Synta Pharmaceuticals Investigative Site, Atlanta, Georgia, 30322
  • Germany

    • Synta Pharmaceuticals Investigative Site, Offenbach, 63069
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