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

Completed · Phase 3 · Has a placebo group

Conditions studied: Liver Cancer

In brief

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

Key facts

Study ID

NCT00825955

Run by

Bristol-Myers Squibb

People needed

587

Starts

2009-02-17

Expected to finish

2017-08-25

Last updated by the study team

2019-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Univ Of Ark For Med Sci — Little Rock, Arkansas, 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
• UF Health Clinical Research Center — Gainesville, Florida, United States
• James Graham Brown Cancer Center — Louisville, Kentucky, United States
• 3912 Taubman Center — Ann Arbor, Michigan, United States
• Henry Ford Health System Irb — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mount Sinai School Of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health & Sci Univ — Portland, Oregon, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• University Of Texas — Houston, Texas, United States
• The University Of Texas Health Science Center — San Antonio, Texas, United States
• Mcguire Dvamc — Richmond, Virginia, United States
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Brussels, Belgium
• Local Institution — Salvador, Estado de Bahia, Brazil
• Local Institution — Salvador - Ba, Estado de Bahia, Brazil
• Local Institution — Porto Alegre, Rio Grande do Sul, Brazil
• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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