Synta Pharmaceuticals, a biopharmaceutical company that develops small molecule drugs for medical conditions, announced that a phase IIb/III clinical trial of ganetespib (STA-9090) in combination with docetaxel in non-small cell lung cancer (NSCLC) will begin in 2011. Ganetespib is a potent inhibitor of heat shock protein 90 (Hsp90) that is structurally unrelated to earlier Hsp90 inhibitors such as 17-AAG.
The phase IIb/III trial will evaluate treatment with ganetespib and docetaxel vs. docetaxel alone, with 1:1 randomization, in patients with Stage IIIb or IV NSCLC who have completed one prior systemic therapy for advanced disease. The phase IIb portion will assess efficacy as measured by progression-free survival in approximately 240 patients. Results from this stage will be used to choose patient subpopulation, by histology or biomarker, for the second stage, the phase III portion. The second stage will assess efficacy as measured by overall survival, and will enroll between 400 and 600 patients.
The phase IIb/III program is designed to lessen risk in the phase III portion by evaluating biomarkers and other patient characteristics in the phase IIb portion that identify patients most likely to benefit from treatment with ganetespib.