Clinical Trials

Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment

Location:

Trial status:

Inactive

Why is this study being done?

The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib

Who is eligible to participate?

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)

Last updated: 04/30/2012

NCT ID:

NCT00825955