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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00825955
Collaborator
(none)
587
Enrollment
113
Locations
2
Arms
102.2
Actual Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
587 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 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)
Actual Study Start Date :
Feb 17, 2009
Actual Primary Completion Date :
Nov 15, 2011
Actual Study Completion Date :
Aug 25, 2017

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

    • Procedure: Best Supportive Care
    Trans-Arterial Chemo-Embolization (TACE) Therapy
    Placebo Comparator: Placebo

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

    Procedure: Best Supportive Care
    Trans-Arterial Chemo-Embolization (TACE) Therapy

    Outcome Measures

    Primary Outcome Measures

    1. 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 [computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death]

    Secondary Outcome Measures

    1. To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria) [35 months]

    2. To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria [35 months]

    3. To assess duration of response, duration of disease control and time to response [6 weeks]

    4. 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 [35 months]

    Eligibility Criteria

    Criteria

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

    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Scottsdale Arizona United States 85259
    2 Univ Of Ark For Med Sci Little Rock Arkansas United States 72205
    3 Loma Linda University Cancer Center Loma Linda California United States 92350
    4 Richard Finn, M.D. Los Angeles California United States 90095-7077
    5 Sharp Clinical Oncology Research San Diego California United States 92123
    6 Pacific Hematology Oncology Associates San Francisco California United States 94115
    7 UF Health Clinical Research Center Gainesville Florida United States 32610
    8 James Graham Brown Cancer Center Louisville Kentucky United States 40202
    9 3912 Taubman Center Ann Arbor Michigan United States 48109
    10 Henry Ford Health System Irb Detroit Michigan United States 48202
    11 Mayo Clinic Rochester Minnesota United States 55905
    12 Mount Sinai School Of Medicine New York New York United States 10029
    13 Columbia University Medical Center New York New York United States 10032
    14 Ohio State University Columbus Ohio United States 43210
    15 Oregon Health & Sci Univ Portland Oregon United States 97239
    16 University Of Pennsylvania Philadelphia Pennsylvania United States 19104
    17 University Of Texas Houston Texas United States 77030
    18 The University Of Texas Health Science Center San Antonio Texas United States 78229
    19 Mcguire Dvamc Richmond Virginia United States 23249
    20 Local Institution Capital Federal Buenos Aires Argentina C1264AAA
    21 Local Institution Rosario Santa FE Argentina 2000
    22 Local Institution Bruxelles Belgium 1000
    23 Local Institution Salvador - Ba Bahia Brazil 40050-410
    24 Local Institution Salvador Bahia Brazil 41825-010
    25 Local Institution Porto Alegre RIO Grande DO SUL Brazil 90610-000
    26 Local Institution Sao Paulo Brazil 05403-010
    27 Local Institution Calgary Alberta Canada T2N 4Z6
    28 Local Institution Vancouver British Columbia Canada V5Z 1M9
    29 Local Institution Toronto Ontario Canada M5G 2N2
    30 Local Institution Beijing Beijing China 100071
    31 Local Institution Guangzhou Guangdong China 510060
    32 Local Institution Guanzhou Guangdong China 610080
    33 Local Institution Nanning Guangxi China 530021
    34 Local Institution Wuhan Hubei China 430030
    35 Local Institution Nanjing Jiangsu China 210002
    36 Local Institution Tianjing Tianjin China 30060
    37 Local Institution Hangzhou Zhejiang China 130016
    38 Local Institution Bordeaux France 33075
    39 Local Institution Creteil Cedex France 94010
    40 Local Institution Grenoble Cedex 09 France 38043
    41 Local Institution Lille Cedex France 59037
    42 Local Institution Lyon Cedex 04 France 69317
    43 Local Institution Montpellier Cedex 5 France 34298
    44 Local Institution Montpellier Cedex France 34295
    45 Local Institution Paris Cedex France 75013
    46 Local Institution Paris France 75020
    47 Local Institution Paris France 75571
    48 Local Institution Rennes France 35042
    49 Local Institution Toulouse Cedex 09 France 31059
    50 Local Institution Vandoeuvre Cedex France 54511
    51 Local Institution Villejuif France 94805
    52 Local Institution Berlin Germany 13353
    53 Local Institution Frankfurt Germany 60590
    54 Local Institution Freiburg Germany 79106
    55 Local Institution Halle Germany 06120
    56 Local Institution Hannover Germany 30625
    57 Local Institution Mainz Germany 55131
    58 Local Institution Ulm Germany 89081
    59 Local Institution Wuerzburg Germany 97080
    60 Local Institution Kifisia Greece 14564
    61 Local Institution Thessaloniki Greece 54642
    62 Local Institution Hong Kong Hong Kong 8525
    63 Local Institution Kochi Kerala India 682304
    64 Local Institution Chennai India 600035
    65 Local Institution Kolkata India 700 053
    66 Local Institution New Delhi India 110 070
    67 Local Institution Ancona Italy 60126
    68 Local Institution Meldola (fc) Italy 47014
    69 Local Institution Milano Italy 20122
    70 Local Institution Milano Italy 20133
    71 Local Institution Napoli Italy 80131
    72 Local Institution Padova Italy 35128
    73 Local Institution Pisa Italy 56124
    74 Local Institution Chiba-shi Chiba Japan 2608677
    75 Local Institution Kashiwa-shi Chiba Japan 2778577
    76 Local Institution Ogaki-shi Gifu Japan 5038502
    77 Local Institution Yokohama Kanagawa Japan 232-0024
    78 Local Institution Kochi-shi Kochi Japan 7818555
    79 Local Institution Kyoto-shi Kyoto Japan 6028566
    80 Local Institution Tsu-shi MIE Japan 5148507
    81 Local Institution Higashinari-ku Osaka Japan 5378511
    82 Local Institution Osaka-sayama-shi Osaka Japan 5898511
    83 Local Institution Osaka-shi Osaka Japan 5438555
    84 Local Institution Osaka-shi Osaka Japan 5458586
    85 Local Institution Sunto-gun Shizuoka Japan 4118777
    86 Local Institution Bunkyo-ku Tokyo Japan 1138655
    87 Local Institution Chuo-ku Tokyo Japan 104-0045
    88 Local Institution Musashino-shi Tokyo Japan 1808610
    89 Local Institution Toyama City Toyama Japan 9308550
    90 Local Institution Shimonoseki-shi Yamaguchi Japan 7500061
    91 Local Institution Nishinomiya-shi Japan 6638501
    92 Local Institution Busan Korea, Republic of 609735
    93 Local Institution Daegu Korea, Republic of 700-721
    94 Local Institution Gyeonggi-do Korea, Republic of 410-769
    95 Local Institution Seoul Korea, Republic of 120-752
    96 Local Institution Seoul Korea, Republic of 135-710
    97 Local Institution Seoul Korea, Republic of 136-701
    98 Local Institution Seoul Korea, Republic of 138-736
    99 Local Institution D.f. Distrito Federal Mexico 14140
    100 Local Institution Toluca Estado DE Mexico Mexico 05440
    101 Local Institution Cuernavaca Morelos Mexico 62290
    102 Local Institution San Juan Puerto Rico 00910
    103 Local Institution Moscow Russian Federation 115478
    104 Local Institution Moscow Russian Federation 119992
    105 Local Institution Moscow Russian Federation 125367
    106 Local Institution Barcelona Spain 08036
    107 Local Institution Madrid Spain 28034
    108 Local Institution Oviedo Spain 33006
    109 Local Institution Taichung Taiwan 404
    110 Local Institution Tainan Taiwan 704
    111 Local Institution Taipei Taiwan 100
    112 Local Institution Taipei Taiwan 112
    113 Local Institution Taoyuan Hsien 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:
    NCT00825955
    Other Study ID Numbers:
    • CA182-034
    • EUDRACT #: 2008-005084-34
    First Posted:
    Jan 21, 2009
    Last Update Posted:
    Oct 9, 2019
    Last Verified:
    Sep 1, 2019
    Additional relevant MeSH terms:
    Liver Neoplasms

    Study Results

    No Results Posted as of Oct 9, 2019