Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
NCT ID: NCT00825955
Last Updated: 2019-10-09
Study Results
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Basic Information
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COMPLETED
PHASE3
587 participants
INTERVENTIONAL
2009-02-17
2017-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Brivanib
Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy
Placebo
Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy
Interventions
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Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
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
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Rosario, Santa Fe Province, Argentina
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Brussels, , Belgium
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Salvador, Estado de Bahia, Brazil
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Salvador - Ba, Estado de Bahia, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Guanzhou, Guangdong, China
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Nanning, Guangxi, China
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Wuhan, Hubei, China
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Nanjing, Jiangsu, China
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Tianjin, Tianjin Municipality, China
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Hangzhou, Zhejiang, China
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Bordeaux, , France
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Créteil, , France
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Grenoble, , France
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Lille, , France
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Lyon, , France
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Montpellier, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Rennes, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Berlin, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Halle, , Germany
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Hanover, , Germany
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Mainz, , Germany
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Ulm, , Germany
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Würzburg, , Germany
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Kifissia, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Kochi, Kerala, India
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Chennai, , India
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Kolkata, , India
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New Delhi, , India
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Ancona, , Italy
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Meldola (fc), , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Pisa, , Italy
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Chiba, Chiba, Japan
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Kashiwa-shi, Chiba, Japan
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Ogaki-shi, Gifu, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kyoto, Kyoto, Japan
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Tsu, Mie-ken, Japan
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Higashinari-ku, Osaka, Japan
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Osaka, Osaka, Japan
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Osaka, Osaka, Japan
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Osaka-sayama-shi, Osaka, Japan
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Sunto-gun, Shizuoka, Japan
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Bunkyo-ku, Tokyo, Japan
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Chuo-ku, Tokyo, Japan
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Musashino-shi, Tokyo, Japan
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Toyama, Toyama, Japan
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Shimonoseki-shi, Yamaguchi, Japan
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Nishinomiya-shi, , Japan
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D.f., Mexico City, Mexico
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Cuernavaca, Morelos, Mexico
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Toluca, State of Mexico, Mexico
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San Juan, , Puerto Rico
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Busan, , South Korea
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Daegu, , South Korea
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Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Oviedo, , Spain
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan Hsien, , Taiwan
Countries
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References
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Lencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Rios J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM. Objective response by mRECIST as a predictor and potential surrogate end-point of overall survival in advanced HCC. J Hepatol. 2017 Jun;66(6):1166-1172. doi: 10.1016/j.jhep.2017.01.012. Epub 2017 Jan 26.
Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol. 2013 Oct 1;31(28):3509-16. doi: 10.1200/JCO.2012.47.3009. Epub 2013 Aug 26.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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EUDRACT #: 2008-005084-34
Identifier Type: -
Identifier Source: secondary_id
CA182-034
Identifier Type: -
Identifier Source: org_study_id
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