Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. recently announced the opening of a randomized, double-blind Phase III trial administering sorafenib (formerly BAY 43-9006) in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with advanced metastatic melanoma.

This multicenter study will evaluate the safety and efficacy of sorafenib, a novel investigational anticancer agent, when co-administered with carboplatin and paclitaxel. The trial, which is expected to enroll over 200 patients, has progression-free survival as its primary endpoint. Participating patients must have failed no more than one previous systemic chemotherapeutic treatment with either dacarbazine (DTIC) or temozolomide. Patients will be randomized to receive 400 mg of oral sorafenib twice daily or matching placebo, in addition to a standard dosing schedule of carboplatin (AUC 6) and paclitaxel (225 mg/m2). The study will include sites in the United States, Canada, Europe, and Australia. Bayer and Onyx also announced that the U.S. Food and Drug Administration (FDA) completed a Special Protocol Assessment (SPA) for the Phase III trial. An SPA is a written agreement on the design and size of clinical trials that are intended to form the basis of a new drug application.

“Metastatic melanoma can be a deadly disease, and there are few treatment options for these patients,” said Scott Freeman, M.D., Vice President of Clinical Development at Onyx. “We are pleased to be evaluating sorafenib in patients with metastatic melanoma.”