Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma

A Phase 1 Open Label/ Phase 2 Randomized, Double-blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar®) in Patients With Advanced Hepatocellular Carcinoma

Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD)

Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone

Inclusion Criteria:

• Advanced liver cancer
• No previous systemic therapy for liver cancer
• Measurable disease on CT or MRI
• ECOG 1 or less
• Child-Pugh A

Exclusion Criteria:

• Active bleeding during the last 30 days
• Known history of HIV seropositivity
• Any severe and/or uncontrolled medical conditions including

Other protocol-defined inclusion/exclusion criteria may apply