BAY 43-9006, a novel RAF kinase and VEGFR inhibitor under investigation for the treatment of different types of cancer, combines two anticancer activities: inhibition of tumor cell proliferation and angiogenesis (the growth of new blood vessels).
The phase III study is designed to measure differences in overall survival, time to symptom progression and time to tumor progression of BAY 43-9006 versus placebo in patients with advanced hepatocellular carcinoma (HCC). The trial will also evaluate the safety and pharmacokinetics of BAY 43-9006.
More than 500 patients with advanced HCC, who have not received previous systemic treatment for their disease, will be randomized to receive 400mg of oral BAY 43-9006 twice daily or matching placebo. This study is expected to enroll patients in the Americas, Europe, and Australia/New Zealand.
“BAY 43-9006 is the first raf kinase inhibitor to be tested in a worldwide HCC phase III study,” said Dr Jordi Bruix, head of the Barcelona Clinic Liver Cancer Group (BCLC) at the University of Barcelona, Spain. “Based on the results seen in the phase II HCC studies, we are pleased to continue the clinical development of BAY 43-9006 in liver cancer, a difficult-to-treat patient population.”