Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Advanced liver cancer

• Prior systemic treatment with sorafenib for advanced HCC and for whom their disease progressed during or after sorafenib treatment, or were intolerant to sorafenib treatment. Specifically, this can be defined as:

• Documented radiological confirmation (radiology scans or report) of disease progression during or after sorafenib treatment

• Intolerance to sorafenib (at any dose and/or duration) is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation.

NOTE:

• Sorafenib must be the last antineoplastic treatment before randomization

• Prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is allowed

• One systemic chemotherapy regimen for advanced HCC is allowed before sorafenib treatment

• ECOG performance status of ≤ 2

• Child-Pugh A

Exclusion Criteria:

• Active bleeding during the last 28 days

• Prior therapy with mTOR inhibitors

• Prior liver or other organ transplantation which mandates systemic immunosuppression

Other protocol-defined inclusion/exclusion criteria may apply