Phase one of the study seeks to evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advanced hepatocellular cancer and to determine the maximum tolerated dose.

Phase two estimates the treatment effect as a measure of anti-tumor activity in terms of time to progression of the combination of RAD001 plus sorafenib at the maximum tolerated dose, as compared to sorafenib alone.

Eligibility

To participate in this study, you must be 18 years of age or older and have:

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

Exlusion Criteria

Patients will be excluded from the trial if they have:

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

Other protocol-defined inclusion and exclusion criteria may apply.

For more information, contact the clinical research coordinator at 919-668-1861.