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

Phase 3

Completed

Interventions: Other: Placebo
Drug: Brivanib
Procedure: Best Supportive Care

Brief 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

Recruitment & Eligibility

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)

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC	computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death

Secondary Outcome Measures

Name	Time	Method
To assess duration of response, duration of disease control and time to response	6 weeks
To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)	35 months
To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria	35 months
To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review	35 months

Locations (20): Mayo Clinic Arizona
🇺🇸
Scottsdale, Arizona, United States
UF Health Clinical Research Center
🇺🇸
Gainesville, Florida, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
University Of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
The University Of Texas Health Science Center
🇺🇸
San Antonio, Texas, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
Local Institution
🇨🇳
Taoyuan Hsien, Taiwan
Mount Sinai School Of Medicine
🇺🇸
New York, New York, United States
University Of Texas
🇺🇸
Houston, Texas, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Mcguire Dvamc
🇺🇸
Richmond, Virginia, United States
Loma Linda University Cancer Center
🇺🇸
Loma Linda, California, United States
Richard Finn, M.D.
🇺🇸
Los Angeles, California, United States
Sharp Clinical Oncology Research
🇺🇸
San Diego, California, United States
Pacific Hematology Oncology Associates
🇺🇸
San Francisco, California, United States
James Graham Brown Cancer Center
🇺🇸
Louisville, Kentucky, United States
Univ Of Ark For Med Sci
🇺🇸
Little Rock, Arkansas, United States
3912 Taubman Center
🇺🇸
Ann Arbor, Michigan, United States
Henry Ford Health System Irb
🇺🇸
Detroit, Michigan, United States
Oregon Health & Sci Univ
🇺🇸
Portland, Oregon, United States