FDAnews
www.fdanews.com/articles/72351-bayer-onyx-initiate-phase-iii-metastatic-melanoma-trial

Bayer, Onyx Initiate Phase III Metastatic Melanoma Trial

May 16, 2005

Bayer Pharmaceuticals and Onyx Pharmaceuticals have 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 more than 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 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 and paclitaxel. The study will include sites in the U.S., Canada, Europe, and Australia.

Bayer and Onyx also announced that the 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.