Bayer and Onyx Complete Enrollment for Phase III Cancer Trials
Posted on: Thursday, 4 May 2006, 15:02 CDT
Bayer and Onyx have completed patient enrollment in two phase III clinical trials evaluating Nexavar in patients with advanced metastatic melanoma and advanced liver cancer.
The melanoma (skin cancer) trial is designed to evaluate the safety and efficacy of Nexavar when co-administered with chemotherapy, and has progression-free survival as its primary endpoint. Approximately 250 patients with disease progression following one previous systemic chemotherapeutic treatment were enrolled into the study.
The phase III study in patients with advanced liver cancer is designed to measure differences in overall survival, time to symptom progression and time to tumor progression of Nexavar versus placebo. Approximately 560 patients who had not received previous systemic treatment for their disease were randomized to receive 400mg of oral Nexavar twice daily or matching placebo.
"Therapy with Nexavar could potentially provide an important advancement in the treatment of these difficult diseases, and we are pleased to have reached these milestones," said Dr Henry Fuchs, executive vice president and chief medical officer of Onyx Pharmaceuticals. "While the studies are still ongoing and analyses will not commence until the pre-specified number of events are reached, we look forward to generating randomized data in these indications."
Source: Datamonitor
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