Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
NCT ID: NCT00908752
Last Updated: 2019-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
734 participants
INTERVENTIONAL
2009-07-20
2018-01-26
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
Adjuvant treatment with TACE Therapy
Brivanib
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
TACE Therapy
Trans-Arterial Chemo-Embolization Therapy
Brivanib Placebo
Placebo adjuvant treatment with TACE Therapy
Brivanib Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
TACE Therapy
Trans-Arterial Chemo-Embolization Therapy
Interventions
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Brivanib
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Brivanib Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
TACE Therapy
Trans-Arterial Chemo-Embolization Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cirrhotic status of Child-Pugh Class A or B with a score of 7
* ECOG performance status of 0 or 1
* Adequate hematologic, hepatic, and renal function
Exclusion Criteria
* History of cardiac disease
* Active and untreated hepatitis B
* Inability to swallow tablets or untreated malabsorption syndrome
* History of human immunodeficiency virus (HIV) infection
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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Richard Finn, M.D.
Los Angeles, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Montefiore Medical Center
The Bronx, New York, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States
University Of Virginia Health System
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Parkville, Victoria, Australia
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Vancouver, British Columbia, Canada
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Montreal, Quebec, Canada
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Beijing, Beijing Municipality, China
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Guanzhou, Guangdong, China
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Nanning, Guangxi, China
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Harbin, Heilongjiang, China
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Changsha, Hunan, China
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Changzhou, Jiangsu, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Changchun, Jilin, China
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Xi'an, Shan3xi, China
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Shanghai, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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Chengdu, Sichuan, China
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Tianjin, Tianjin Municipality, China
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Hangzhou, Zhejiang, China
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Angers, , France
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Bondy, , France
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Bordeaux, , France
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Clichy, , 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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Marseille, , France
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Paris, , France
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Paris, , France
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Toulouse, , France
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Hong Kong, , Hong Kong
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New Territories, , Hong Kong
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Genova, , Italy
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Padua, , Italy
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Pisa, , Italy
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Roma, , Italy
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Toyoake, Aichi-ken, Japan
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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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Hiroshima, Hiroshima, Japan
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Kure-shi, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Kanazawa, Ishikawa-ken, Japan
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Kawasaki-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kumamoto, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Tsu, Mie-ken, Japan
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Okayama, Okayama-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, Osaka, Japan
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Ōsaka-sayama, Osaka, Japan
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Sunto-gun, Shizuoka, Japan
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Chuo-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Musashino-shi, Tokyo, Japan
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Toyama, Toyama, Japan
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Nishinomiya-shi, , Japan
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Busan, , South Korea
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Kyunggi-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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Seoul, , South Korea
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Suwon, , South Korea
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Taegu, , South Korea
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Madrid, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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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 District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
Countries
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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 # 2008-008715-26
Identifier Type: -
Identifier Source: secondary_id
CA182-037
Identifier Type: -
Identifier Source: org_study_id
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