RxTrials Institute Drug Pipeline Alert

ImClone Systems has reached an agreement with the FDA under a special protocol assessment for its Phase III trial of IMC-1121B in women with metastatic breast cancer.

The randomized, double-blind, multinational, placebo-controlled trial will compare IMC-1121B plus docetaxel with placebo plus docetaxel in 1,100 women. The primary endpoint is progression-free survival. Patient enrollment is expected to begin in the third quarter of the year, ImClone said.

The company also is studying IMC-1121B in patients with advanced melanoma and renal cancers. In February, it began enrollment in a multicenter, multinational, open-label Phase II trial of patients with advanced, inoperable liver cancer who have not received chemotherapy or other systemic therapies.