Abstract
7506 Background: Approximately 70% of melanomas have an activating mutation in BRAF, leading to elevated RAF kinase activity and cellular proliferation. BAY 43-9006 is a potent RAF kinase inhibitor that retards the growth of human melanoma xenografts. This phase II study aims to determine the clinical benefit and toxicity of BAY 43-9006 in advanced melanoma and to correlate these findings with BRAF status of the patients and their tumours. Methods: Patients with stage IV refractory melanoma were recruited from The Royal Marsden Melanoma Unit and treated with BAY 43-9006 400mg BD orally for 12 weeks after baseline imaging and tumour biopsy. At the 12 week reassessment, patients with objective tumour responses continued BAY 43-9006 until disease progression or unacceptable toxicity. Patients with stable disease were randomised in a double-blind manner between BAY 43-9006 or placebo and followed for on-going response.In the event of disease progression in this cohort, the code was broken and those receiving ...
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