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

• Status: Completed
• Trial end date: 2017-08-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Sorafenib

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)