A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment - The EVOLVE-1 Study
A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment - The EVOLVE-1 Study
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.
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:
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
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
La Jolla, California 92093-0658, United States
San Francisco, California 94120-7999, United States
Baltimore, Maryland 21287-0013, United States
Boston, Massachusetts 02114, United States
Bethlehem, Pennsylvania, United States
Dallas, Texas 75390-8527, United States
San Antonio, Texas 78229, United States
Roanoke, Virginia 24018, United States
Caen Cedex9, 14033, France
Marseille Cédex 5, 13385, France
Chuo-ku, Tokyo 104-0045, Japan
Shinagawa-ku, Tokyo 141-8625, Japan
Niaosong Township, Taiwan 83301, Taiwan
Liouying Township, Taiwan