A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)

Inclusion Criteria:

- Histologic or cytologic confirmed diagnosis of HCC

- Advanced disease defined as (i) disease not eligible for surgical or loco-regional
therapy or (ii) disease progressive after surgical or loco-regional therapy

- Patient has failed ≥ 14 days of Sorafenib treatment

- Cirrhotic status of Child-Pugh Class A or B with a score of 7

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

- Subjects who have a life expectancy of at least 8 weeks

- Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

- women of childbearing potential (WOCBP) who are unwilling or unable to use an
acceptable method to avoid pregnancy

- Previous or concurrent cancer that is distinct in primary site

- History of active cardiac disease

- Thrombotic or embolic events within the past 6 months

- Any other hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events
(CTCAE) Grade 3 within 4 weeks

- Inability to swallow tablets or untreated malabsorption syndrome

- History of human immunodeficiency virus (HIV) infection

- Prior use of systemic investigational agents for HCC (except for Sorafenib)