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BRISK-APS: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT01108705
Collaborator
(none)
87
Enrollment
32
Locations
2
Arms
41
Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
87 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brivanib

Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Other Names:
  • BMS-582664

    		•
    Placebo Comparator: Placebo

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

    Outcome Measures

    Primary Outcome Measures

    1. 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 [Every 6 weeks for an average of 6 months]

    Secondary Outcome Measures

    1. Compare time to progression (TTP) using modified RECIST for HCC [Every 6 weeks]

    2. Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC [Every 6 weeks]

    3. Assess duration of response, duration of disease control and time to response [Every 6 weeks]

    4. Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results [Every 6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Hefei Anhui China 230022
    2 Local Institution Beijing Beijing China 100021
    3 Local Institution Beijing Beijing China 100071
    4 Local Institution Beijing Beijing China 100853
    5 Local Institution Chongqing Chongqing China 400038
    6 Local Institution Fu Zhou Fujian China 350014
    7 Local Institution Fuzhou Fujian China 350025
    8 Local Institution Guangzhou Guangdong China 510060
    9 Local Institution Guangzhou Guangdong China 510515
    10 Local Institution Guanzhou Guangdong China 610080
    11 Local Institution Ha Erbin Heilongjiang China 150040
    12 Local Institution Hankou Hubei China 430023
    13 Local Institution Wuhan Hubei China 430030
    14 Local Institution Nanjing Jiangsu China 210002
    15 Local Institution Nanjing Jiangsu China 210029
    16 Local Institution Suzhou Jiangsu China 215006
    17 Local Institution Chang Chun Jilin China 130012
    18 Local Institution Changchun Jilin China 130021
    19 Local Institution Shenyang Liaoning China 110001
    20 Local Institution Shanghai Shanghai China 200032
    21 Local Institution Shanghai Shanghai China 200080
    22 Local Institution Chengdu Sichuan China 610041
    23 Local Institution Tianjing Tianjin China 300060
    24 Local Institution Hangzhou Zhejiang China 310022
    25 Local Institution Xi An China 710000
    26 Local Institution Xi'an China 710038
    27 Local Institution Gyeonggi-do Korea, Republic of 410-769
    28 Local Institution Seoul Korea, Republic of 135-710
    29 Local Institution Singapore Singapore 308433
    30 Local Institution Kaohsiung County Taiwan 833
    31 Local Institution Taipei Taiwan 11217
    32 Local Institution Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01108705
    Other Study ID Numbers:
    • CA182-047
    First Posted:
    Apr 22, 2010
    Last Update Posted:
    Oct 12, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Oct 12, 2015