Liver CancerPhase 3BRISK PSNCT00825955

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

A Phase 3 study testing Brivanib in people with Liver Cancer, run by Bristol-Myers Squibb at 113 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Cancer
What is being tested?: Brivanib
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 587 participants
Where: 113 sitesin 19 countries
Study dates: 17 Feb 2009to 25 Aug 2017
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

113 sites in 19 countries.

Country

City, postcode or hospital

113 sites in 19 countries

United States19 sites

3912 Taubman Center
Ann Arbor, Michigan, 48109
Ohio State University
Columbus, Ohio, 43210
Henry Ford Health System Irb
Detroit, Michigan, 48202
UF Health Clinical Research Center
Gainesville, Florida, 32610
University Of Texas
Houston, Texas, 77030
Univ Of Ark For Med Sci
Little Rock, Arkansas, 72205
Loma Linda University Cancer Center
Loma Linda, California, 92350
Richard Finn, M.D.
Los Angeles, California, 90095-7077
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Mount Sinai School Of Medicine
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Sci Univ
Portland, Oregon, 97239
Mcguire Dvamc
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
The University Of Texas Health Science Center
San Antonio, Texas, 78229
Sharp Clinical Oncology Research
San Diego, California, 92123
Pacific Hematology Oncology Associates
San Francisco, California, 94115
Mayo Clinic Arizona
Scottsdale, Arizona, 85259

Other trials in United States

Japan18 sites

Local Institution
Bunkyo-ku, Tokyo, 1138655
Local Institution
Chiba, Chiba, 2608677
Local Institution
Chuo-ku, Tokyo, 104-0045
Local Institution
Higashinari-ku, Osaka, 5378511
Local Institution
Kashiwa-shi, Chiba, 2778577
Local Institution
Kochi, Kochi, 7818555
Local Institution
Kyoto, Kyoto, 6028566
Local Institution
Musashino-shi, Tokyo, 1808610
Local Institution
Nishinomiya-shi, 6638501
Local Institution
Ogaki-shi, Gifu, 5038502
Local Institution
Osaka, Osaka, 5438555
Local Institution
Osaka, Osaka, 5458586
Local Institution
Osaka-sayama-shi, Osaka, 5898511
Local Institution
Shimonoseki-shi, Yamaguchi, 7500061
Local Institution
Sunto-gun, Shizuoka, 4118777
Local Institution
Toyama, Toyama, 9308550
Local Institution
Tsu, Mie-ken, 5148507
Local Institution
Yokohama, Kanagawa, 232-0024

Other trials in Japan

France14 sites

Local Institution
Bordeaux, 33075
Local Institution
Créteil, 94010
Local Institution
Grenoble, 38043
Local Institution
Lille, 59037
Local Institution
Lyon, 69317
Local Institution
Montpellier, 34295
Local Institution
Montpellier, 34298
Local Institution
Paris, 75013
Local Institution
Paris, 75020
Local Institution
Paris, 75571
Local Institution
Rennes, 35042
Local Institution
Toulouse, 31059
Local Institution
Vandœuvre-lès-Nancy, 54511
Local Institution
Villejuif, 94805

Other trials in France

China8 sites

Local Institution
Beijing, Beijing Municipality, 100071
Local Institution
Guangzhou, Guangdong, 510060
Local Institution
Guanzhou, Guangdong, 610080
Local Institution
Hangzhou, Zhejiang, 130016
Local Institution
Nanjing, Jiangsu, 210002
Local Institution
Nanning, Guangxi, 530021
Local Institution
Tianjin, Tianjin Municipality, 30060
Local Institution
Wuhan, Hubei, 430030

Other trials in China

Germany8 sites

Local Institution
Berlin, 13353
Local Institution
Frankfurt, 60590
Local Institution
Freiburg im Breisgau, 79106
Local Institution
Halle, 06120
Local Institution
Hanover, 30625
Local Institution
Mainz, 55131
Local Institution
Ulm, 89081
Local Institution
Würzburg, 97080

Other trials in Germany

Italy7 sites

Local Institution
Ancona, 60126
Local Institution
Meldola (fc), 47014
Local Institution
Milan, 20122
Local Institution
Milan, 20133
Local Institution
Naples, 80131
Local Institution
Padova, 35128
Local Institution
Pisa, 56124

Other trials in Italy

South Korea7 sites

Local Institution
Busan, 609735
Local Institution
Daegu, 700-721
Local Institution
Gyeonggi-do, 410-769
Local Institution
Seoul, 120-752
Local Institution
Seoul, 135-710
Local Institution
Seoul, 136-701
Local Institution
Seoul, 138-736

Other trials in South Korea

Taiwan5 sites

Local Institution
Taichung, 404
Local Institution
Tainan, 704
Local Institution
Taipei, 100
Local Institution
Taipei, 112
Local Institution
Taoyuan Hsien, 333

Other trials in Taiwan

Brazil4 sites

Local Institution
Porto Alegre, Rio Grande do Sul, 90610-000
Local Institution
Salvador, Estado de Bahia, 41825-010
Local Institution
Salvador - Ba, Estado de Bahia, 40050-410
Local Institution
São Paulo, 05403-010

Other trials in Brazil

India4 sites

Local Institution
Chennai, 600035
Local Institution
Kochi, Kerala, 682304
Local Institution
Kolkata, 700 053
Local Institution
New Delhi, 110 070

Other trials in India

Canada3 sites

Local Institution
Calgary, Alberta, T2N 4Z6
Local Institution
Toronto, Ontario, M5G 2N2
Local Institution
Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Mexico3 sites

Local Institution
Cuernavaca, Morelos, 62290
Local Institution
D.f., Mexico City, 14140
Local Institution
Toluca, State of Mexico, 05440

Other trials in Mexico

Russia3 sites

Local Institution
Moscow, 115478
Local Institution
Moscow, 119992
Local Institution
Moscow, 125367

Other trials in Russia

Spain3 sites

Local Institution
Barcelona, 08036
Local Institution
Madrid, 28034
Local Institution
Oviedo, 33006

Other trials in Spain

Argentina2 sites

Local Institution
Capital Federal, Buenos Aires, C1264AAA
Local Institution
Rosario, Santa Fe Province, 2000

Other trials in Argentina

Greece2 sites

Local Institution
Kifissia, 14564
Local Institution
Thessaloniki, 54642

Other trials in Greece

Belgium1 site

Local Institution
Brussels, 1000

Other trials in Belgium

Hong Kong1 site

Local Institution
Hong Kong, 8525

Other trials in Hong Kong

Puerto Rico1 site

Local Institution
San Juan, 00910

Other trials in Puerto Rico

About this study

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)

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

Conditions: Liver Cancer
Being tested: Brivanib, Placebo, Best Supportive Care
Medical subject headings: Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BrivanibDrug
Also called BMS-582664
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
PlaceboOther
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Best Supportive CareProcedure or surgery
Trans-Arterial Chemo-Embolization (TACE) Therapy

Study groups in NCT00825955
Study group	Role	What they receive
Brivanib	Experimental	Not described Receives: Drug: Brivanib; Procedure: Best Supportive Care
Placebo	Placebo comparator	Not described Receives: Other: Placebo; Procedure: Best Supportive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Measured: 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
Measured: 35 months
To assess duration of response, duration of disease control and time to response
Measured: 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
Measured: 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 200925 Aug 2017

First posted21 Jan 2009 (estimated)
Study start17 Feb 2009
Primary completion15 Nov 2011
Study completion25 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Liver CancerStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 587 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00825955
Sponsor's protocol ID: CA182-034
Other IDs: EUDRACT #: 2008-005084-34
Acronym: BRISK PS
Status last verified: Sep 2019
First submitted: 20 Jan 2009
Last updated: 9 Oct 2019
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 28131794
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.
PubMed 23980090

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00825955
Acronym / sponsor ID: BRISK PS / CA182-034
Conditions: Liver Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 587 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 17 Feb 2009 (actual)
Primary completion: 15 Nov 2011 (actual)
Study completion: 25 Aug 2017 (actual)
First posted: 21 Jan 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Brivanib	Experimental	Drug: Brivanib, Procedure: Best Supportive Care
Placebo	Placebo comparator	Other: Placebo, Procedure: Best Supportive Care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BrivanibAlso: BMS-582664Tablets, Oral, 800 mg, once daily, until disease progression or toxicity	Drug	Brivanib
PlaceboTablets, Oral, 0 mg, once daily, until disease progression or toxicity	Other	Placebo
Best Supportive CareTrans-Arterial Chemo-Embolization (TACE) Therapy	Procedure or surgery	Brivanib, Placebo

Primary outcome

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

4 secondary outcomes

To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)
Time frame: 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
Time frame: 35 months
To assess duration of response, duration of disease control and time to response
Time frame: 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
Time frame: 35 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
Derived from this study: PubMed 28131794Lencioni 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.
Derived from this study: PubMed 23980090Llovet 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.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Liver Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

113 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brivanib in people with Liver Cancer, run by Bristol-Myers Squibb at 113 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Japan, France, China, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00825955, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.