are opening a randomized, double-blind Phase III trial in which sorafenib will be administered with chemotherapies carboplatin and paclitaxel to patients with advanced metastatic melanoma.
The companies expect the trial to enroll more than 200 patients. The primary endpoint is progression-free survival. Patients will be randomized to receive 400 mg of oral sorafenib twice daily or a matching placebo, in addition to a standard dosing schedule of carboplatin and paclitaxel. The study will include sites in the U.S., Canada, Europe and Australia.
Sorafenib is being evaluated both as a single therapy agent and in combination with other oncology agents in a number of clinical trials.
Shares of Onyx were down 73 cents, or 2.3%, to $31.71, and Bayer's American depositary shares were losing 40 cents, or 1.2%, to $33.04.