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

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Niacinamide; Sirolimus; Sorafenib

Criteria

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