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BRISK FL: First Line Hepato Cellular Carcinoma (HCC)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00858871
Collaborator
(none)
1,714
Enrollment
173
Locations
2
Arms
52
Duration (Months)
9.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1714 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 Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Brivanib

Drug: Brivanib
Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
Other Names:
  • BMS-582664

    • Drug: Placebo
    Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity
    Active Comparator: Sorafenib

    Drug: Sorafenib
    Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity

    Drug: Placebo
    Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity

    Outcome Measures

    Primary Outcome Measures

    1. To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment [Survival will be assessed continuously]

    Secondary Outcome Measures

    1. To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC [Every 6 weeks]

    2. To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC [Every 6 weeks]

    3. To determine duration of response, duration of disease control, and time to response (TTR) [Every 6 weeks]

    4. To assess the safety profile of brivanib and sorafenib [Every 6 weeks]

    5. To explore PK and exposure-response in the study population [Every 6 weeks]

    6. To compare time to symptomatic progression [Every 6 weeks]

    7. To compare health-related quality of life [Every 6 weeks]

    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 HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies

    • Child-Pugh Class A

    • ECOG performance status 0-1

    • Adequate hematologic, hepatic, and renal function

    Exclusion Criteria:

    • Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC

    • History of active cardiac disease

    • Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)

    • Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices

    • Inability to swallow tablets or untreated malabsorption syndrome

    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 Agajanian Institute Of Hematology And Oncology Downey California United States 90241
    4 Sharp Clinical Oncology Research San Diego California United States 92123
    5 Va Ct Healthcare System West Haven Connecticut United States 06516
    6 Medical Specialists Of Palm Beaches Lake Worth Florida United States 33467
    7 James Graham Brown Cancer Center Louisville Kentucky United States 40202
    8 3912 Taubman Center Ann Arbor Michigan United States 48109
    9 Karmanos Cancer Institute Detroit Michigan United States 48201
    10 Thomas Jefferson Univ. Philadelphia Pennsylvania United States 19107
    11 Mcguire Dvamc Richmond Virginia United States 23249
    12 University Of Wisconsin Madison Wisconsin United States 53792
    13 Local Institution Caba Buenos Aires Argentina 1221
    14 Local Institution Capital Federal Buenos Aires Argentina C1264AAA
    15 Local Institution Rosario Santa Fe Argentina 2000
    16 Local Institution Buenos Aires Argentina C1181ACH
    17 Local Institution Camperdown New South Wales Australia 2050
    18 Local Institution Concord New South Wales Australia 2139
    19 Local Institution Westmead Nsw New South Wales Australia 2145
    20 Local Institution Parkville Victoria Australia 3050
    21 Local Institution Prahan Victoria Australia 3004
    22 Local Institution Liege Belgium 4000
    23 Local Institution Salvador - Ba Bahia Brazil 40050-410
    24 Local Institution Salvador Bahia Brazil 41950-610
    25 Local Institution Fortaleza Ceara Brazil 60430-230
    26 Local Institution Goiania Goias Brazil 74075-040
    27 Local Institution Divinopolis Minas Gerais Brazil 35500-249
    28 Local Institution Curitiba Parana Brazil 81520-060
    29 Local Institution Porto Alegre Rio Grande do Sul Brazil 90035-903
    30 Local Institution Porto Alegre Rio Grande Do Sul Brazil 90050-170
    31 Local Institution Porto Alegre Rio Grande Do Sul Brazil 90610-000
    32 Local Institution Barretos Sao Paulo Brazil 14784-400
    33 Local Institution Jau Sao Paulo Brazil 17210-080
    34 Local Institution Sao Paulo Brazil 01323-010
    35 Local Institution Calgary Alberta Canada T2N 2T9
    36 Local Institution Vancouver British Columbia Canada V5Z 1M9
    37 Local Institution London Ontario Canada N6A A5
    38 Local Institution Montreal Quebec Canada H2X 3J4
    39 Local Institution Beijing Beijing China 100021
    40 Local Institution Beijing Beijing China 100034
    41 Local Institution Beijing Beijing China 100071
    42 Local Institution Chongqing Chongqing China 400038
    43 Local Institution Guangzhou Guangdong China 510515
    44 Local Institution Guanzhou Guangdong China 510010
    45 Local Institution Nanning Guangxi China 530021
    46 Local Institution Wuhan Hubei China 430030
    47 Local Institution Changsha Hunan China 410008
    48 Local Institution Changzhou Jiangsu China 213003
    49 Local Institution Nanjing Jiangsu China 210000
    50 Local Institution Nanjing Jiangsu China 210002
    51 Local Institution Nanjing Jiangsu China 210008
    52 Local Institution Suzhou Jiangsu China 215006
    53 Local Institution Dalian Liaoning China 116011
    54 Local Institution Xi An Shaanxi China 710032
    55 Local Institution Shanghai Shanghai China 200080
    56 Local Institution Chengdu Sichuan China 610041
    57 Local Institution Hangzhou Zhejiang China 130016
    58 Local Institution Brno Czech Republic 656 53
    59 Local Institution Prague 5 Czech Republic 150 06
    60 Local Institution Praha 2 Czech Republic 128 08
    61 Local Institution Bordeaux France 33075
    62 Local Institution Clichy Cedex France 92118
    63 Local Institution Creteil Cedex France 94010
    64 Local Institution Grenoble Cedex 09 France 38043
    65 Local Institution Lille France 59037
    66 Local Institution Lyon Cedex 04 France 69317
    67 Local Institution Marseille Cedex 05 France 13385
    68 Local Institution Marseille Cedex 9 France 13009
    69 Local Institution Paris France 75012
    70 Local Institution Paris France 75013
    71 Local Institution Paris France 75020
    72 Local Institution Rennes France 35042
    73 Local Institution Vandoeuvre Cedex France 54511
    74 Local Institution Berlin Germany 13353
    75 Local Institution Halle Germany 06120
    76 Local Institution Hamburg Germany 20246
    77 Local Institution Magdeburg Germany 39120
    78 Local Institution Ulm Germany 89081
    79 Local Institution Hong Kong Hong Kong 8525
    80 Local Institution Shatin Hong Kong 8520
    81 Local Institution Hyderabad Andhra Pradesh India 500082
    82 Local Institution Kochi Kerala India 682304
    83 Local Institution Trivandrum Kerala India 695011
    84 Local Institution Pune Maharashtra India 411001
    85 Local Institution Ahmedabad India 380009
    86 Local Institution Chennai India 600006
    87 Local Institution Coimbatore India 641037
    88 Local Institution Hyderabad India 500024
    89 Local Institution Kolkata India 700 053
    90 Local Institution Kolkata India 700054
    91 Local Institution Mumbai India 400012
    92 Local Institution Mumbai India 400036
    93 Local Institution New Delhi India 110 070
    94 Local Institution Milano Italy 20122
    95 Local Institution Milano Italy 20141
    96 Local Institution Napoli Italy 80131
    97 Local Institution Pisa Italy 56124
    98 Local Institution Roma Italy 00168
    99 Local Institution Torrette -Ancona Italy 60020
    100 Local Institution Kashiwa-shi Chiba Japan 277-0882
    101 Local Institution Sapporo-shi Hokkaido Japan 060-0033
    102 Local Institution Kanazawa-Shi Ishikawa Japan 9208641
    103 Local Institution Kawasaki-shi Kanagawa Japan 2138587
    104 Local Institution Yokohama Kanagawa Japan 232-0024
    105 Local Institution Tsu-shi MIE Japan 5148507
    106 Local Institution Okayama-shi Okayama Japan 7000082
    107 Local Institution Higashinari-ku Osaka Japan 5378511
    108 Local Institution Osaka-Sayama City Osaka Japan 5890014
    109 Local Institution Osaka-shi Osaka Japan 534-0021
    110 Local Institution Osaka-shi Osaka Japan 5438555
    111 Local Institution Osaka-shi Osaka Japan 5458586
    112 Local Institution Sunto-gun Shizuoka Japan 411-8777
    113 Local Institution Chuo-Ku Tokyo Japan 104-0045
    114 Local Institution Minato-ku Tokyo Japan 105-0001
    115 Local Institution Musashino-shi Tokyo Japan 180-0023
    116 Local Institution Shimonoseki-shi Yamaguchi Japan 7500061
    117 Local Institution Nishinomiya-shi Japan 6638501
    118 Local Institution Busan Korea, Republic of 609-735
    119 Local Institution Daegu Korea, Republic of 700-721
    120 Local Institution Gyeonggi-do Korea, Republic of 410-769
    121 Local Institution Kyunggi-do Korea, Republic of 463-707
    122 Local Institution Seoul Korea, Republic of 110-744
    123 Local Institution Seoul Korea, Republic of 120-752
    124 Local Institution Seoul Korea, Republic of 135-710
    125 Local Institution Seoul Korea, Republic of 137-040
    126 Local Institution Seoul Korea, Republic of 138-736
    127 Local Institution D.f. Distrito Federal Mexico 06720
    128 Local Institution D.f. Distrito Federal Mexico 14140
    129 Local Institution Mexico City Distrito Federal Mexico 06726
    130 Local Institution Tlalpan Distrito Federal Mexico 14000
    131 Local Institution Monterrey Nuevo Leon Mexico 64710
    132 Local Institution Aguascalientes Mexico 20234
    133 Local Institution Distrito Federal Mexico 06760
    134 Local Institution Gdansk Poland 80952
    135 Local Institution Gliwice Poland 44-101
    136 Local Institution Krakow Poland 31-501
    137 Local Institution Warszawa Poland 02-781
    138 Local Institution San Juan Puerto Rico 00910
    139 Local Institution Moscow Russian Federation 115 478
    140 Local Institution Moscow Russian Federation 115998
    141 Local Institution Moscow Russian Federation 119992
    142 Local Institution Moscow Russian Federation 125367
    143 Local Institution Pretoria Gauteng South Africa 0002
    144 Local Institution Durban Kwa Zulu Natal South Africa 4091
    145 Local Institution Cape Town Western Cape South Africa 7570
    146 Local Institution Observatory, Cape Town Western Cape South Africa 7925
    147 Local Institution Rondebosch Western Cape South Africa 7700
    148 Local Institution Santiago De Compostela A Coruna Spain 15706
    149 Local Institution Alicante Spain 03010
    150 Local Institution Barcelona Spain 08208
    151 Local Institution Stockholm Sweden 141 86
    152 Local Institution Uppsala Sweden 751 85
    153 Local Institution Changhua Taiwan 500
    154 Local Institution Kaohsiung Taiwan 833
    155 Local Institution Taichung Taiwan 404
    156 Local Institution Tainan R.O.C. Taiwan 70403
    157 Local Institution Taipei Taiwan 100
    158 Local Institution Taipei Taiwan 112
    159 Local Institution Taoyuan Taiwan 333
    160 Local Institution Bangkok Thailand 10400
    161 Local Institution Bangkok Thailand 10700
    162 Local Institution Ankara Turkey 06460
    163 Local Institution Antalya Turkey 07070
    164 Local Institution Istanbul Turkey
    165 Local Institution Izmir Turkey 35100
    166 Local Institution Kayseri Turkey 38039
    167 Local Institution Bristol Avon United Kingdom BS2 8ED
    168 Local Institution London Greater London United Kingdom NW3 2QG
    169 Local Institution London Greater London United Kingdom SE5 9RS
    170 Local Institution London Greater London United Kingdom W12 0HS
    171 Local Institution Manchester Greater Manchester United Kingdom M20 4BX
    172 Local Institution Birmingham West Midlands United Kingdom B15 2TT
    173 Local Institution Leeds Yorkshire United Kingdom LS9 7TF

    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:
    NCT00858871
    Other Study ID Numbers:
    • CA182-033
    • EUDRACT # 2008-003533-24
    First Posted:
    Mar 10, 2009
    Last Update Posted:
    Oct 17, 2016
    Last Verified:
    Oct 1, 2016
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Sorafenib

    Study Results

    No Results Posted as of Oct 17, 2016