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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
587

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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