Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment (BRISK PS)

September 27, 2019 updated by: Bristol-Myers Squibb

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)

The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

587

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
      • Capital Federal, Buenos Aires, Argentina, C1264AAA
        • Local Institution
    • Santa FE
      • Rosario, Santa FE, Argentina, 2000
        • Local Institution
  • Belgium
      • Bruxelles, Belgium, 1000
        • Local Institution
  • Brazil
      • Sao Paulo, Brazil, 05403-010
        • Local Institution
    • Bahia
      • Salvador, Bahia, Brazil, 41825-010
        • Local Institution
      • Salvador - Ba, Bahia, Brazil, 40050-410
        • Local Institution
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Local Institution
  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Local Institution
      • Guanzhou, Guangdong, China, 610080
        • Local Institution
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Local Institution
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Local Institution
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Local Institution
    • Tianjin
      • Tianjing, Tianjin, China, 30060
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, China, 130016
        • Local Institution
  • France
      • Bordeaux, France, 33075
        • Local Institution
      • Creteil Cedex, France, 94010
        • Local Institution
      • Grenoble Cedex 09, France, 38043
        • Local Institution
      • Lille Cedex, France, 59037
        • Local Institution
      • Lyon Cedex 04, France, 69317
        • Local Institution
      • Montpellier Cedex, France, 34295
        • Local Institution
      • Montpellier Cedex 5, France, 34298
        • Local Institution
      • Paris, France, 75020
        • Local Institution
      • Paris, France, 75571
        • Local Institution
      • Paris Cedex, France, 75013
        • Local Institution
      • Rennes, France, 35042
        • Local Institution
      • Toulouse Cedex 09, France, 31059
        • Local Institution
      • Vandoeuvre Cedex, France, 54511
        • Local Institution
      • Villejuif, France, 94805
        • Local Institution
  • Germany
      • Berlin, Germany, 13353
        • Local Institution
      • Frankfurt, Germany, 60590
        • Local Institution
      • Freiburg, Germany, 79106
        • Local Institution
      • Halle, Germany, 06120
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
      • Ulm, Germany, 89081
        • Local Institution
      • Wuerzburg, Germany, 97080
        • Local Institution
  • Greece
      • Kifisia, Greece, 14564
        • Local Institution
      • Thessaloniki, Greece, 54642
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong, 8525
        • Local Institution
  • India
      • Chennai, India, 600035
        • Local Institution
      • Kolkata, India, 700 053
        • Local Institution
      • New Delhi, India, 110 070
        • Local Institution
    • Kerala
      • Kochi, Kerala, India, 682304
        • Local Institution
  • Italy
      • Ancona, Italy, 60126
        • Local Institution
      • Meldola (fc), Italy, 47014
        • Local Institution
      • Milano, Italy, 20122
        • Local Institution
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Pisa, Italy, 56124
        • Local Institution
  • Japan
      • Nishinomiya-shi, Japan, 6638501
        • Local Institution
    • Chiba
      • Chiba-shi, Chiba, Japan, 2608677
        • Local Institution
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution
    • Gifu
      • Ogaki-shi, Gifu, Japan, 5038502
        • Local Institution
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Local Institution
    • Kochi
      • Kochi-shi, Kochi, Japan, 7818555
        • Local Institution
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 6028566
        • Local Institution
    • MIE
      • Tsu-shi, MIE, Japan, 5148507
        • Local Institution
    • Osaka
      • Higashinari-ku, Osaka, Japan, 5378511
        • Local Institution
      • Osaka-sayama-shi, Osaka, Japan, 5898511
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5438555
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5458586
        • Local Institution
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 4118777
        • Local Institution
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138655
        • Local Institution
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 1808610
        • Local Institution
    • Toyama
      • Toyama City, Toyama, Japan, 9308550
        • Local Institution
    • Yamaguchi
      • Shimonoseki-shi, Yamaguchi, Japan, 7500061
        • Local Institution
  • Korea, Republic of
      • Busan, Korea, Republic of, 609735
        • Local Institution
      • Daegu, Korea, Republic of, 700-721
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 410-769
        • 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, 136-701
        • Local Institution
  • Mexico
    • Distrito Federal
      • D.f., Distrito Federal, Mexico, 14140
        • Local Institution
    • Estado DE Mexico
      • Toluca, Estado DE Mexico, Mexico, 05440
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00910
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 119992
        • Local Institution
      • Moscow, Russian Federation, 125367
        • Local Institution
      • Moscow, Russian Federation, 115478
        • Local Institution
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
      • Madrid, Spain, 28034
        • Local Institution
      • Oviedo, Spain, 33006
        • Local Institution
  • Taiwan
      • Taichung, Taiwan, 404
        • Local Institution
      • Tainan, Taiwan, 704
        • Local Institution
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
      • Taoyuan Hsien, Taiwan, 333
        • Local Institution
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Univ Of Ark For Med Sci
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University Cancer Center
      • Los Angeles, California, United States, 90095-7077
        • Richard Finn, M.D.
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
      • San Francisco, California, United States, 94115
        • Pacific Hematology Oncology Associates
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Health Clinical Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • 3912 Taubman Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System Irb
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sci Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC

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:

  • Histologic or cytologic confirmed diagnosis of HCC
  • 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:

  • women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy
  • 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)

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
Placebo Comparator: Placebo
Procedure: Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy
Other: Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Experimental: Brivanib
Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Other Names:
  • BMS-582664
Procedure: Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC
Time Frame: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death
computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)
Time Frame: 35 months
35 months
To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria
Time Frame: 35 months
35 months
To assess duration of response, duration of disease control and time to response
Time Frame: 6 weeks
6 weeks
To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review
Time Frame: 35 months
35 months

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.

General Publications

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)

February 17, 2009

Primary Completion (Actual)

November 15, 2011

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA182-034
  • EUDRACT #: 2008-005084-34

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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