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news.Synta Pharmaceuticals is set to initiate a Phase 2b/3 clinical trial of ganetespib (STA-9090) in combination with docetaxel in non-small cell lung cancer (NSCLC) in the second quarter of 2011.
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Ganetespib is a potent, synthetic, small-molecule inhibitor of heat shock protein 90 – a molecular chaperone required for the proper folding and activation of many cancer-promoting proteins.
The Phase 2b/3 trial will evaluate treatment with ganetespib plus docetaxel versus docetaxel alone, with 1:1 randomisation, in patients with Stage IIIB or IV NSCLC who have completed one prior systemic therapy for advanced disease.
The first stage, Phase 2b portion will evaluate efficacy as measured by progression-free survival in approximately 240 patients.
Results from this stage will be used to inform the choice of patient subpopulation for the second stage, Phase 3 portion.
The second stage will evaluate efficacy as measured by overall survival, and will enroll between 400 and 600 patients.
The trial is expected to start in Q2 2011, while the interim results from the first-stage portion of the trial are expected by end of 2011 or early 2012.