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

NCT ID: NCT00908752

Last Updated: 2019-12-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

734 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-20

Study Completion Date

2018-01-26

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Brivanib

Adjuvant treatment with TACE Therapy

Group Type ACTIVE_COMPARATOR

Brivanib

Intervention Type DRUG

Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

TACE Therapy

Intervention Type PROCEDURE

Trans-Arterial Chemo-Embolization Therapy

Brivanib Placebo

Placebo adjuvant treatment with TACE Therapy

Group Type PLACEBO_COMPARATOR

Brivanib Placebo

Intervention Type OTHER

Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

TACE Therapy

Intervention Type PROCEDURE

Trans-Arterial Chemo-Embolization Therapy

Interventions

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Brivanib

Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

Intervention Type DRUG

Brivanib Placebo

Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

Intervention Type OTHER

TACE Therapy

Trans-Arterial Chemo-Embolization Therapy

Intervention Type PROCEDURE

Other Intervention Names

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BMS-582664

Eligibility Criteria

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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 Criteria

* Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Sharp Clinical Oncology Research

San Diego, California, United States

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Montefiore Medical Center

The Bronx, New York, United States

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Rhode Island Hospital

Providence, Rhode Island, United States

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The University Of Texas MD Anderson Cancer Center

Houston, Texas, United States

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University Of Virginia Health System

Charlottesville, Virginia, United States

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Seattle Cancer Care Alliance

Seattle, Washington, United States

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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

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Countries

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United States Argentina Australia Canada China France Hong Kong Italy Japan South Korea Spain Taiwan Thailand

Related Links

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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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