Back to resultsComparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment (BRISK PS)
Primary Purpose
Liver Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivanib
Placebo
Best Supportive Care
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer
Eligibility Criteria
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)
Sites / Locations
- Mayo Clinic Arizona
- Univ Of Ark For Med Sci
- Loma Linda University Cancer Center
- Richard Finn, M.D.
- Sharp Clinical Oncology Research
- Pacific Hematology Oncology Associates
- UF Health Clinical Research Center
- James Graham Brown Cancer Center
- 3912 Taubman Center
- Henry Ford Health System Irb
- Mayo Clinic
- Mount Sinai School Of Medicine
- Columbia University Medical Center
- Ohio State University
- Oregon Health & Sci Univ
- University Of Pennsylvania
- University Of Texas
- The University Of Texas Health Science Center
- Mcguire Dvamc
- Local Institution
- Local Institution
- Local Institution
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Brivanib
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)
To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria
To assess duration of response, duration of disease control and time to response
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
Full Information
NCT ID
NCT00825955
First Posted
January 20, 2009
Last Updated
September 27, 2019
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00825955
Brief Title
Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
Acronym
BRISK PS
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 17, 2009 (Actual)
Primary Completion Date
November 15, 2011 (Actual)
Study Completion Date
August 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
587 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brivanib
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Intervention Type
Procedure
Intervention Name(s)
Best Supportive Care
Intervention Description
Trans-Arterial Chemo-Embolization (TACE) Therapy
Primary Outcome Measure Information:
Title
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
Time Frame
computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death
Secondary Outcome Measure Information:
Title
To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)
Time Frame
35 months
Title
To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria
Time Frame
35 months
Title
To assess duration of response, duration of disease control and time to response
Time Frame
6 weeks
Title
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
Time Frame
35 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Univ Of Ark For Med Sci
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Richard Finn, M.D.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7077
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UF Health Clinical Research Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
3912 Taubman Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System Irb
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mount Sinai School Of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Sci Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University Of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University Of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Mcguire Dvamc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1264AAA
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Local Institution
City
Salvador - Ba
State/Province
Bahia
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41825-010
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
610080
Country
China
Facility Name
Local Institution
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Local Institution
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Tianjing
State/Province
Tianjin
ZIP/Postal Code
30060
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
130016
Country
China
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Local Institution
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Local Institution
City
Montpellier Cedex
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Paris Cedex
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Local Institution
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Local Institution
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Vandoeuvre Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution
City
Kifisia
ZIP/Postal Code
14564
Country
Greece
Facility Name
Local Institution
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Local Institution
City
Hong Kong
ZIP/Postal Code
8525
Country
Hong Kong
Facility Name
Local Institution
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682304
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
Local Institution
City
Kolkata
ZIP/Postal Code
700 053
Country
India
Facility Name
Local Institution
City
New Delhi
ZIP/Postal Code
110 070
Country
India
Facility Name
Local Institution
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Local Institution
City
Meldola (fc)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Local Institution
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
5038502
Country
Japan
Facility Name
Local Institution
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Local Institution
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
7818555
Country
Japan
Facility Name
Local Institution
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6028566
Country
Japan
Facility Name
Local Institution
City
Tsu-shi
State/Province
MIE
ZIP/Postal Code
5148507
Country
Japan
Facility Name
Local Institution
City
Higashinari-ku
State/Province
Osaka
ZIP/Postal Code
5378511
Country
Japan
Facility Name
Local Institution
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5438555
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Local Institution
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Local Institution
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138655
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Local Institution
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
1808610
Country
Japan
Facility Name
Local Institution
City
Toyama City
State/Province
Toyama
ZIP/Postal Code
9308550
Country
Japan
Facility Name
Local Institution
City
Shimonoseki-shi
State/Province
Yamaguchi
ZIP/Postal Code
7500061
Country
Japan
Facility Name
Local Institution
City
Nishinomiya-shi
ZIP/Postal Code
6638501
Country
Japan
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
609735
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
136-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
D.f.
State/Province
Distrito Federal
ZIP/Postal Code
14140
Country
Mexico
Facility Name
Local Institution
City
Toluca
State/Province
Estado DE Mexico
ZIP/Postal Code
05440
Country
Mexico
Facility Name
Local Institution
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00910
Country
Puerto Rico
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan Hsien
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28131794
Citation
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.
Results Reference
derived
PubMed Identifier
23980090
Citation
Llovet 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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
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