Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma
Status:
Withdrawn
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
This study is establish whether INC280 is safe and has beneficial effects in patients with
advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose
disease progressed while on, or after, treatment with sorafenib or who are intolerant to
sorafenib.
Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best
supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study
treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280
treatment upon documented further disease progression (RECIST 1.1) per investigator's
discretion after unblinding.
Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden
(present macroscopic vascular invasion and/or extra-hepatic spread vs not present).