Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma

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).

Inclusion Criteria:

- Confirmed c-MET pathway dysregulation.- Hepatocellular carcinoma stage B or C
according to the Barcelona Clinic Liver cancer staging classification. - Current
cirrhotic status of Child-Pugh class A with no encephalopathy. - Documented disease
progression during or after discontinuation of sorafenib treatment or intolerance to
sorafenib treatment. - Measurable disease as determined by RECIST v1.1. - ECOG
performance status ≤ 1

Exclusion Criteria:

- Previous local antineoplastic therapy or investigational drug completed less than 5
half-lives of the agent prior to randomization and have not recovered from clinically
significant toxicity from such treatment to grade ≤1 by the NCI-CTCAE. - Received
any targeted therapy other than sorafenib.

- Active bleeding within 28 days prior to screening visit including variceal bleeding
(esophageal varices should be treated according to standard practice and procedure
completed 28 days prior to screening visit). - Clinically significant venous or
arterial thrombotic disease within past 6 months.