Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment (BRISK-APS)

September 23, 2015 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 Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib

The purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

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

  • China
      • Xi An, China, 710000
        • Local Institution
      • Xi'an, China, 710038
        • Local Institution
    • Anhui
      • Hefei, Anhui, China, 230022
        • Local Institution
    • Beijing
      • Beijing, Beijing, China, 100021
        • Local Institution
      • Beijing, Beijing, China, 100071
        • Local Institution
      • Beijing, Beijing, China, 100853
        • Local Institution
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Local Institution
    • Fujian
      • Fu Zhou, Fujian, China, 350014
        • Local Institution
      • Fuzhou, Fujian, China, 350025
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Local Institution
      • Guangzhou, Guangdong, China, 510060
        • Local Institution
      • Guanzhou, Guangdong, China, 610080
        • Local Institution
    • Heilongjiang
      • Ha Erbin, Heilongjiang, China, 150040
        • Local Institution
    • Hubei
      • Hankou, Hubei, China, 430023
        • Local Institution
      • Wuhan, Hubei, China, 430030
        • Local Institution
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Local Institution
      • Nanjing, Jiangsu, China, 210029
        • Local Institution
      • Suzhou, Jiangsu, China, 215006
        • Local Institution
    • Jilin
      • Chang Chun, Jilin, China, 130012
        • Local Institution
      • Changchun, Jilin, China, 130021
        • Local Institution
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Local Institution
      • Shanghai, Shanghai, China, 200032
        • Local Institution
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution
    • Tianjin
      • Tianjing, Tianjin, China, 300060
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 410-769
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
  • Taiwan
      • Kaohsiung County, Taiwan, 833
        • Local Institution
      • Taipei, Taiwan, 11217
        • Local Institution
      • Taoyuan, Taiwan, 333
        • Local Institution

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

Key Inclusion Criteria:

  • Diagnosis of advanced hepatocellular carcinoma
  • Asian ethnicity
  • 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 performance status of 0, 1, or 2
  • Life expectancy of at least 8 weeks
  • Adequate hematologic, hepatic, and renal function

Key Exclusion Criteria:

  • Women of childbearing potential 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
  • Inability to swallow tablets or untreated malabsorption syndrome
  • History of HIV infection
  • Prior use of systemic investigational agents for hepatocellular carcinoma (except 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
Drug: Placebo
Tablets, Oral, 0mg, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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: Every 6 weeks for an average of 6 months
Every 6 weeks for an average of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare time to progression (TTP) using modified RECIST for HCC
Time Frame: Every 6 weeks
Every 6 weeks
Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC
Time Frame: Every 6 weeks
Every 6 weeks
Assess duration of response, duration of disease control and time to response
Time Frame: Every 6 weeks
Every 6 weeks
Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results
Time Frame: Every 6 weeks
Every 6 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

May 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA182-047

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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