Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. have started 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 multi-centre 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 enrol 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.
The study will include sites in the United States, Canada, Europe, and Australia. Bayer and Onyx also announced that the US Food and Drug Administration (FDA) completed a Special Protocol Assessment (SPA) for the Phase III trial.
Cancer of the skin (nonmelanoma and melanoma skin cancers combined) is the most common type of cancer, accounting for more than 50 percent of all cancers. Melanoma accounts for about four percent of skin cancer cases but causes about 79 per cent of skin cancer deaths.
Sorafenib, a novel investigational drug candidate, is the first oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumour cell and tumour vasculature.