Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC

Last updated: November 26, 2019
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Liver Cancer

Liver Disorders

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT00908752
CA182-037
EUDRACT # 2008-008715-26
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.

Eligibility Criteria

Inclusion

For more information regarding BMS clinical trial participation, please visitwww.BMSStudyConnect.com. Inclusion Criteria:

  • Patients with diagnosis of hepatocellular carcinoma

  • 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

Exclusion criteria:

  • Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational ormolecular targeted agents for HCC

  • History of cardiac disease

  • Active and untreated hepatitis B

  • Inability to swallow tablets or untreated malabsorption syndrome

  • History of human immunodeficiency virus (HIV) infection

Study Design

Total Participants: 734
Study Start date:
July 20, 2009
Estimated Completion Date:
January 26, 2018

Connect with a study center

  • Local Institution

    Capital Federal, Buenos Aires C1405BCK
    Argentina

    Site Not Available

  • Local Institution

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Local Institution

    Buenos Aires, C1181ACH
    Argentina

    Site Not Available

  • Local Institution

    Westmead Nsw, New South Wales 2145
    Australia

    Site Not Available

  • Local Institution

    Footscray, Victoria 3011
    Australia

    Site Not Available

  • Local Institution

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Local Institution

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Local Institution

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Local Institution

    Montreal, Quebec H2X 3J4
    Canada

    Site Not Available

  • Local Institution

    Beijing, Beijing 100071
    China

    Site Not Available

  • Local Institution

    Guanzhou, Guangdong 610080
    China

    Site Not Available

  • Local Institution

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Local Institution

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • Local Institution

    Changsha, Hunan 410013
    China

    Site Not Available

  • Local Institution

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Local Institution

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Local Institution

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Local Institution

    Changchun, Jilin 130021
    China

    Site Not Available

  • Local Institution

    Dalian, Liaoning 116011
    China

    Site Not Available

  • Local Institution

    Xi'an, Shan3xi 710032
    China

    Site Not Available

  • Local Institution

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Local Institution

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Local Institution

    Tianjing, Tianjin 30060
    China

    Site Not Available

  • Local Institution

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Local Institution

    Angers, 49933
    France

    Site Not Available

  • Local Institution

    Bondy, 93143
    France

    Site Not Available

  • Local Institution

    Bordeaux, 33075
    France

    Site Not Available

  • Local Institution

    Clichy Cedex, 92118
    France

    Site Not Available

  • Local Institution

    Creteil Cedex, 94010
    France

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  • Local Institution

    Grenoble, 38043
    France

    Site Not Available

  • Local Institution

    Lille Cedex, 59037
    France

    Site Not Available

  • Local Institution

    Lyon Cedex 04, 69317
    France

    Site Not Available

  • Local Institution

    Marseille Cedex 05, 13385
    France

    Site Not Available

  • Local Institution

    Paris, 75012
    France

    Site Not Available

  • Local Institution

    Paris Cedex, 75013
    France

    Site Not Available

  • Local Institution

    Toulouse Cedex 09, 31059
    France

    Site Not Available

  • Local Institution

    Hong Kong, 8525
    Hong Kong

    Site Not Available

  • Local Institution

    New Territories, 8520
    Hong Kong

    Site Not Available

  • Local Institution

    Genova, 16132
    Italy

    Site Not Available

  • Local Institution

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution

    Pisa, 56124
    Italy

    Site Not Available

  • Local Institution

    Roma, 00168
    Italy

    Site Not Available

  • Local Institution

    Toyoake City, Aichi 470-1101
    Japan

    Site Not Available

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    Chiba-shi, Chiba 2608677
    Japan

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    Kashiwa-shi, Chiba 277-0882
    Japan

    Site Not Available

  • Local Institution

    Ogaki-shi, Gifu 5038502
    Japan

    Site Not Available

  • Local Institution

    Hiroshima City, Hiroshima 734-0037
    Japan

    Site Not Available

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    Kure-shi, Hiroshima 7370023
    Japan

    Site Not Available

  • Local Institution

    Sapporo-shi, Hokkaido 060-0033
    Japan

    Site Not Available

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    Kanazawa-shi, Ishikawa 9208641
    Japan

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  • Local Institution

    Kawasaki-shi, Kanagawa 2138587
    Japan

    Site Not Available

  • Local Institution

    Yokohama, Kanagawa 232-0024
    Japan

    Site Not Available

  • Local Institution

    Kochi-shi, Kochi 7818555
    Japan

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  • Local Institution

    Kumamoto-shi, Kumamoto 8608556
    Japan

    Site Not Available

  • Local Institution

    Kyoto-shi, Kyoto 6028566
    Japan

    Site Not Available

  • Local Institution

    Tsu-shi, MIE 5148507
    Japan

    Site Not Available

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    Okayama-shi, Okayama 700-0082
    Japan

    Site Not Available

  • Local Institution

    Higashinari-ku, Osaka 5378511
    Japan

    Site Not Available

  • Local Institution

    Osaka-sayama City, Osaka 5890014
    Japan

    Site Not Available

  • Local Institution

    Osaka-shi, Osaka 5438555
    Japan

    Site Not Available

  • Local Institution

    Sunto-gun, Shizuoka 411-8777
    Japan

    Site Not Available

  • Local Institution

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Local Institution

    Minato-ku, Tokyo 105-0001
    Japan

    Site Not Available

  • Local Institution

    Musashino-shi, Tokyo 180-0023
    Japan

    Site Not Available

  • Local Institution

    Toyama City, Toyama 9308550
    Japan

    Site Not Available

  • Local Institution

    Kyoto,
    Japan

    Site Not Available

  • Local Institution

    Nishinomiya-shi, 6638501
    Japan

    Site Not Available

  • Local Institution

    Busan, 609735
    Korea, Republic of

    Site Not Available

  • Local Institution

    Kyunggi-do, 463-707
    Korea, Republic of

    Site Not Available

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    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Local Institution

    Suwon, 443-721
    Korea, Republic of

    Site Not Available

  • Local Institution

    Taegu, 700721
    Korea, Republic of

    Site Not Available

  • Local Institution

    Madrid, 28007
    Spain

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    Valencia, 46014
    Spain

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    Kaohsiung, 80756
    Taiwan

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    Taichung, 404
    Taiwan

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  • Local Institution

    Tainan, 704
    Taiwan

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    Taipei, 100
    Taiwan

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  • Local Institution

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Local Institution

    Bangkok, 10400
    Thailand

    Site Not Available

  • Richard Finn, M.D.

    Los Angeles, California 90095
    United States

    Site Not Available

  • Sharp Clinical Oncology Research

    San Diego, California 92123
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467-2401
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Vanderbilt University Med Ctr

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • The University Of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University Of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109-1023
    United States

    Site Not Available

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