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

November 26, 2019 updated by: Bristol-Myers Squibb

A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

734

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1405BCK
        • Local Institution
  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Local Institution
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • Local Institution
  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Local Institution
    • Guangdong
      • Guanzhou, Guangdong, China, 610080
        • Local Institution
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Local Institution
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Local Institution
    • Hunan
      • Changsha, Hunan, China, 410013
        • Local Institution
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Local Institution
      • Nanjing, Jiangsu, China, 210000
        • Local Institution
      • Nanjing, Jiangsu, China, 210002
        • Local Institution
      • Nanjing, Jiangsu, China, 210009
        • Local Institution
      • Suzhou, Jiangsu, China, 215006
        • Local Institution
    • Jilin
      • Changchun, Jilin, China, 130021
        • Local Institution
    • Shan3xi
      • Xi'an, Shan3xi, China, 710032
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Local Institution
      • Shanghai, Shanghai, China, 200433
        • Local Institution
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution
    • Tianjin
      • Tianjing, Tianjin, China, 30060
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution
  • France
      • Angers, France, 49933
        • Local Institution
      • Bondy, France, 93143
        • Local Institution
      • Bordeaux, France, 33075
        • Local Institution
      • Clichy Cedex, France, 92118
        • Local Institution
      • Creteil Cedex, France, 94010
        • Local Institution
      • Grenoble, France, 38043
        • Local Institution
      • Lille Cedex, France, 59037
        • Local Institution
      • Lyon Cedex 04, France, 69317
        • Local Institution
      • Marseille Cedex 05, France, 13385
        • Local Institution
      • Paris, France, 75012
        • Local Institution
      • Paris Cedex, France, 75013
        • Local Institution
      • Toulouse Cedex 09, France, 31059
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong, 8525
        • Local Institution
      • New Territories, Hong Kong, 8520
        • Local Institution
  • Italy
      • Genova, Italy, 16132
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Pisa, Italy, 56124
        • Local Institution
      • Roma, Italy, 00168
        • Local Institution
  • Japan
      • Nishinomiya-shi, Japan, 6638501
        • Local Institution
    • Aichi
      • Toyoake City, Aichi, Japan, 470-1101
        • Local Institution
    • Chiba
      • Chiba-shi, Chiba, Japan, 2608677
        • Local Institution
      • Kashiwa-shi, Chiba, Japan, 277-0882
        • Local Institution
    • Gifu
      • Ogaki-shi, Gifu, Japan, 5038502
        • Local Institution
    • Hiroshima
      • Hiroshima City, Hiroshima, Japan, 734-0037
        • Local Institution
      • Kure-shi, Hiroshima, Japan, 7370023
        • Local Institution
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Local Institution
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9208641
        • Local Institution
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 2138587
        • Local Institution
      • Yokohama, Kanagawa, Japan, 232-0024
        • Local Institution
    • Kochi
      • Kochi-shi, Kochi, Japan, 7818555
        • Local Institution
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 8608556
        • Local Institution
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 6028566
        • Local Institution
    • MIE
      • Tsu-shi, MIE, Japan, 5148507
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-0082
        • Local Institution
    • Osaka
      • Higashinari-ku, Osaka, Japan, 5378511
        • Local Institution
      • Osaka-sayama City, Osaka, Japan, 5890014
        • Local Institution
      • Osaka-shi, Osaka, Japan, 534-0021
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5438555
        • Local Institution
      • Osaka-shi, Osaka, Japan, 545-8586
        • Local Institution
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Local Institution
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Local Institution
      • Minato-ku, Tokyo, Japan, 105-0001
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 180-0023
        • Local Institution
    • Toyama
      • Toyama City, Toyama, Japan, 9308550
        • Local Institution
  • Korea, Republic of
      • Busan, Korea, Republic of, 609735
        • Local Institution
      • Kyunggi-do, Korea, Republic of, 463-707
        • Local Institution
      • Seoul, Korea, Republic of, 110-744
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 138-736
        • Local Institution
      • Seoul, Korea, Republic of, 137-701
        • Local Institution
      • Suwon, Korea, Republic of, 443-721
        • Local Institution
      • Taegu, Korea, Republic of, 700721
        • Local Institution
  • Spain
      • Madrid, Spain, 28007
        • Local Institution
      • Madrid, Spain, 28222
        • Local Institution
      • Valencia, Spain, 46014
        • Local Institution
      • Valencia, Spain, 46010
        • Local Institution
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Local Institution
      • Taichung, Taiwan, 404
        • Local Institution
      • Tainan, Taiwan, 704
        • Local Institution
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
      • Taoyuan, Taiwan, 333
        • Local Institution
  • Thailand
      • Bangkok, Thailand, 10400
        • Local Institution
      • Bangkok, Thailand, 10700
        • Local Institution
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Richard Finn, M.D.
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
    • New York
      • Bronx, New York, United States, 10467-2401
        • Montefiore Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Brivanib
Adjuvant treatment with TACE Therapy
Drug: Brivanib
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Other Names:
  • BMS-582664
Procedure: TACE Therapy
Trans-Arterial Chemo-Embolization Therapy
Placebo Comparator: Brivanib Placebo
Placebo adjuvant treatment with TACE Therapy
Procedure: TACE Therapy
Trans-Arterial Chemo-Embolization Therapy
Other: Brivanib Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Survival will be assessed continuously
Survival will be assessed continuously

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
Time Frame: Every 8 weeks
Every 8 weeks
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
Time Frame: Every 8 weeks
Every 8 weeks
To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms
Time Frame: End of Study
End of Study
To evaluate the safety of brivanib in combination with TACE
Time Frame: Every 8 weeks
Every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2009

Primary Completion (Actual)

September 28, 2012

Study Completion (Actual)

January 26, 2018

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA182-037
  • EUDRACT # 2008-008715-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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