Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
BRISK PS
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)
2 other identifiers
interventional
587
19 countries
113
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2009
Longer than P75 for phase_3
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 21, 2009
CompletedStudy Start
First participant enrolled
February 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2017
CompletedOctober 9, 2019
September 1, 2019
2.7 years
January 20, 2009
September 27, 2019
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (4)
To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)
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
35 months
To assess duration of response, duration of disease control and time to response
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
35 months
Study Arms (2)
Brivanib
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (113)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Univ Of Ark For Med Sci
Little Rock, Arkansas, 72205, United States
Loma Linda University Cancer Center
Loma Linda, California, 92350, United States
Richard Finn, M.D.
Los Angeles, California, 90095-7077, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
UF Health Clinical Research Center
Gainesville, Florida, 32610, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
3912 Taubman Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System Irb
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Mount Sinai School Of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health & Sci Univ
Portland, Oregon, 97239, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University Of Texas
Houston, Texas, 77030, United States
The University Of Texas Health Science Center
San Antonio, Texas, 78229, United States
Mcguire Dvamc
Richmond, Virginia, 23249, United States
Local Institution
Capital Federal, Buenos Aires, C1264AAA, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Brussels, 1000, Belgium
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Salvador, Estado de Bahia, 41825-010, Brazil
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Salvador - Ba, Estado de Bahia, 40050-410, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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SĂ£o Paulo, 05403-010, Brazil
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Calgary, Alberta, T2N 4Z6, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Toronto, Ontario, M5G 2N2, Canada
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Beijing, Beijing Municipality, 100071, China
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Guangzhou, Guangdong, 510060, China
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Guanzhou, Guangdong, 610080, China
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Nanning, Guangxi, 530021, China
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Wuhan, Hubei, 430030, China
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Nanjing, Jiangsu, 210002, China
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Tianjin, Tianjin Municipality, 30060, China
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Hangzhou, Zhejiang, 130016, China
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Bordeaux, 33075, France
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Créteil, 94010, France
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Grenoble, 38043, France
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Lille, 59037, France
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Lyon, 69317, France
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Montpellier, 34295, France
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Montpellier, 34298, France
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Paris, 75013, France
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Paris, 75020, France
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Paris, 75571, France
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Rennes, 35042, France
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Toulouse, 31059, France
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VandÅ“uvre-lès-Nancy, 54511, France
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Villejuif, 94805, France
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Berlin, 13353, Germany
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Frankfurt, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Halle, 06120, Germany
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Hanover, 30625, Germany
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Mainz, 55131, Germany
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Ulm, 89081, Germany
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WĂ¼rzburg, 97080, Germany
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Kifissia, 14564, Greece
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Thessaloniki, 54642, Greece
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Hong Kong, 8525, Hong Kong
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Kochi, Kerala, 682304, India
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Chennai, 600035, India
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Kolkata, 700 053, India
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New Delhi, 110 070, India
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Ancona, 60126, Italy
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Meldola (fc), 47014, Italy
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Milan, 20122, Italy
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Milan, 20133, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Pisa, 56124, Italy
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Chiba, Chiba, 2608677, Japan
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Kashiwa-shi, Chiba, 2778577, Japan
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Ogaki-shi, Gifu, 5038502, Japan
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Yokohama, Kanagawa, 232-0024, Japan
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Kochi, Kochi, 7818555, Japan
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Kyoto, Kyoto, 6028566, Japan
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Tsu, Mie-ken, 5148507, Japan
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Higashinari-ku, Osaka, 5378511, Japan
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Osaka, Osaka, 5438555, Japan
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Osaka, Osaka, 5458586, Japan
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Osaka-sayama-shi, Osaka, 5898511, Japan
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Sunto-gun, Shizuoka, 4118777, Japan
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Bunkyo-ku, Tokyo, 1138655, Japan
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Chuo-ku, Tokyo, 104-0045, Japan
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Musashino-shi, Tokyo, 1808610, Japan
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Toyama, Toyama, 9308550, Japan
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Shimonoseki-shi, Yamaguchi, 7500061, Japan
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Nishinomiya-shi, 6638501, Japan
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D.f., Mexico City, 14140, Mexico
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Cuernavaca, Morelos, 62290, Mexico
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Toluca, State of Mexico, 05440, Mexico
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San Juan, 00910, Puerto Rico
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Moscow, 115478, Russia
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Moscow, 119992, Russia
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Moscow, 125367, Russia
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Busan, 609735, South Korea
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Daegu, 700-721, South Korea
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Gyeonggi-do, 410-769, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 136-701, South Korea
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Seoul, 138-736, South Korea
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Barcelona, 08036, Spain
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Madrid, 28034, Spain
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Oviedo, 33006, Spain
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Taichung, 404, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taoyuan Hsien, 333, Taiwan
Related Publications (2)
Lencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Rios J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM. Objective response by mRECIST as a predictor and potential surrogate end-point of overall survival in advanced HCC. J Hepatol. 2017 Jun;66(6):1166-1172. doi: 10.1016/j.jhep.2017.01.012. Epub 2017 Jan 26.
PMID: 28131794DERIVEDLlovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol. 2013 Oct 1;31(28):3509-16. doi: 10.1200/JCO.2012.47.3009. Epub 2013 Aug 26.
PMID: 23980090DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 21, 2009
Study Start
February 17, 2009
Primary Completion
November 15, 2011
Study Completion
August 25, 2017
Last Updated
October 9, 2019
Record last verified: 2019-09