First Line Hepato Cellular Carcinoma (HCC)

Status:	Completed
Conditions:	Liver Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	May 2009
End Date:	September 2013

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in
subjects with advanced HCC who have not received prior systemic therapy.

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

- Histologic or cytologic confirmed diagnosis of HCC.

- Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR
progressive disease after surgical and/or locoregional therapies

- Child-Pugh Class A

- ECOG performance status 0-1

- Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

- Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular
targeted agents for HCC

- History of active cardiac disease

- Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)

- Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for
esophageal or gastric varices

- Inability to swallow tablets or untreated malabsorption syndrome

We found this trial at

sites

University of Wisconsin

Madison, Wisconsin 53792

(608) 263-2400