Synta Pharmaceuticals has initiated a Phase IIb/III GALAXY trial of ganetespib in combination with docetaxel in patients with non-small cell lung cancer.
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 IIb/III trial will evaluate treatment with ganetespib and docetaxel compared with docetaxel alone, in patients with Stage IIIB or IV non-small cell lung cancer who have completed one prior systemic therapy.
The first stage will assess efficacy as measured by progression-free survival in approximately 240 patients, while the second stage will assess efficacy as measured by overall survival in between 400 and 600 patients.
Synta Pharmaceuticals senior vice-president and chief medical officer Vojo Vukovic said the combination of ganetespib and docetaxel has a strong scientific rationale as both drugs have single agent activity in non-small cell lung cancer, their mechanisms of anticancer activity are complementary, and their toxicities are non-overlapping.
”Interim results from the first-stage portion of the trial are expected in early 2012,” Vukovic said.