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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Liver Cancer

Treatments

Procedure: Best Supportive Care

Other: Placebo

Drug: Brivanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00825955

CA182-034

EUDRACT #: 2008-005084-34

Details and patient eligibility

About

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

Enrollment

587 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

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)