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



Status:Terminated
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:February 17, 2009
End Date:August 25, 2017

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A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)

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


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)
We found this trial at
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Ann Arbor, Michigan 48109
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Capital Federal, Buenos Aires
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Detroit, Michigan 48202
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Gainesville, Florida 32610
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Houston, Texas 77030
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Little Rock, Arkansas 72205
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Loma Linda, California 92354
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Los Angeles, California 90095
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529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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New York, New York 10029
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Richmond, Virginia 23249
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Rochester, Minnesota 55905
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San Diego, California 92123
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San Francisco, California 94115
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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