Ariad Announces Phase III Clinical Trial of Oral Deforolimus

Ariad Pharmaceuticals has reached agreement on a special protocol assessment with the FDA for its global Phase III trial of oral deforolimus in patients with metastatic sarcomas.

The primary endpoint for the trial is progression-free survival, and overall survival will be a secondary endpoint. Ariad and Merck are jointly developing and commercializing deforolimus.

Ariad and Merck plan to conduct a Phase III trial of oral deforolimus in patients with metastatic soft-tissue and bone sarcomas following a favorable response to chemotherapy.

The double-blind trial will evaluate approximately 650 patients who will be randomized to oral deforolimus or placebo at approximately 125 sites. Complete patient enrollment and the second interim analysis are expected to take place within approximately two years of the first patient being enrolled, Ariad and Merck said.