Hepatocellular CarcinomaPhase 3BRISK TANCT00908752
Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
A Phase 3 study testing Brivanib and TACE Therapy in people with Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 94 sites in 13 countries.
Trial summary
The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Brivanib and TACE Therapy
- 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
- 734 participants
- Where
- 94 sitesin 13 countries
- Study dates
- 20 Jul 2009to 26 Jan 2018
- 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
- Patients with diagnosis of hepatocellular carcinoma
- Cirrhotic status of Child-Pugh Class A or B with a score of 7
- ECOG performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function
Who cannot join
- Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
- History of cardiac disease
- Active and untreated hepatitis B
- Inability to swallow tablets or untreated malabsorption syndrome
- History of human immunodeficiency virus (HIV) infection
Trial locations and contacts
94 sites in 13 countries.
94 sites in 13 countries
Japan26 sites
Local Institution
Chiba, Chiba, 2608677
Local Institution
Chuo-ku, Tokyo, 104-0045
Local Institution
Higashinari-ku, Osaka, 5378511
Local Institution
Hiroshima, Hiroshima, 734-0037
Local Institution
Kanazawa, Ishikawa-ken, 9208641
Local Institution
Kashiwa-shi, Chiba, 277-0882
Local Institution
Kawasaki-shi, Kanagawa, 2138587
Local Institution
Kochi, Kochi, 7818555
Local Institution
Kumamoto, Kumamoto, 8608556
Local Institution
Kure-shi, Hiroshima, 7370023
Local Institution
Kyoto, Kyoto, 6028566
Local Institution
Minato-ku, Tokyo, 105-0001
Local Institution
Musashino-shi, Tokyo, 180-0023
Local Institution
Nishinomiya-shi, 6638501
Local Institution
Ogaki-shi, Gifu, 5038502
Local Institution
Okayama, Okayama-ken, 700-0082
Local Institution
Osaka, Osaka, 534-0021
Local Institution
Osaka, Osaka, 5438555
Local Institution
Osaka, Osaka, 545-8586
Local Institution
Ōsaka-sayama, Osaka, 5890014
Local Institution
Sapporo, Hokkaido, 060-0033
Local Institution
Sunto-gun, Shizuoka, 411-8777
Local Institution
Toyama, Toyama, 9308550
Local Institution
Toyoake, Aichi-ken, 470-1101
Local Institution
Tsu, Mie-ken, 5148507
Local Institution
Yokohama, Kanagawa, 232-0024
China17 sites
Local Institution
Beijing, Beijing Municipality, 100071
Local Institution
Changchun, Jilin, 130021
Local Institution
Changsha, Hunan, 410013
Local Institution
Changzhou, Jiangsu, 213003
Local Institution
Chengdu, Sichuan, 610041
Local Institution
Guanzhou, Guangdong, 610080
Local Institution
Hangzhou, Zhejiang, 310022
Local Institution
Harbin, Heilongjiang, 150081
Local Institution
Nanjing, Jiangsu, 210000
Local Institution
Nanjing, Jiangsu, 210002
Local Institution
Nanjing, Jiangsu, 210009
Local Institution
Nanning, Guangxi, 530021
Local Institution
Shanghai, Shanghai Municipality, 200032
Local Institution
Shanghai, Shanghai Municipality, 200433
Local Institution
Suzhou, Jiangsu, 215006
Local Institution
Tianjin, Tianjin Municipality, 30060
Local Institution
Xi'an, Shan3xi, 710032
France12 sites
Local Institution
Angers, 49933
Local Institution
Bondy, 93143
Local Institution
Bordeaux, 33075
Local Institution
Clichy, 92118
Local Institution
Créteil, 94010
Local Institution
Grenoble, 38043
Local Institution
Lille, 59037
Local Institution
Lyon, 69317
Local Institution
Marseille, 13385
Local Institution
Paris, 75012
Local Institution
Paris, 75013
Local Institution
Toulouse, 31059
South Korea9 sites
Local Institution
Busan, 609735
Local Institution
Kyunggi-do, 463-707
Local Institution
Seoul, 110-744
Local Institution
Seoul, 120-752
Local Institution
Seoul, 135-710
Local Institution
Seoul, 137-701
Local Institution
Seoul, 138-736
Local Institution
Suwon, 443-721
Local Institution
Taegu, 700721
United States7 sites
University Of Virginia Health System
Charlottesville, Virginia, 22908
The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Richard Finn, M.D.
Los Angeles, California, 90095
Rhode Island Hospital
Providence, Rhode Island, 02903
Sharp Clinical Oncology Research
San Diego, California, 92123
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
Montefiore Medical Center
The Bronx, New York, 10467-2401
Taiwan6 sites
Local Institution
Kaohsiung City, 80756
Local Institution
Taichung, 404
Local Institution
Tainan, 704
Local Institution
Taipei, 100
Local Institution
Taipei, 112
Local Institution
Taoyuan, 333
Italy4 sites
Local Institution
Genova, 16132
Local Institution
Padova, 35128
Local Institution
Pisa, 56124
Local Institution
Roma, 00168
Spain4 sites
Local Institution
Madrid, 28007
Local Institution
Madrid, 28222
Local Institution
Valencia, 46010
Local Institution
Valencia, 46014
Argentina2 sites
Local Institution
Buenos Aires, C1181ACH
Local Institution
Capital Federal, Buenos Aires, C1405BCK
Canada2 sites
Local Institution
Montreal, Quebec, H2X 3J4
Local Institution
Vancouver, British Columbia, V5Z 1M9
Hong Kong2 sites
Local Institution
Hong Kong, 8525
Local Institution
New Territories, 8520
Thailand2 sites
Local Institution
Bangkok, 10400
Local Institution
Bangkok, 10700
About this study
Official title: A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Brivanib, Brivanib Placebo, TACE Therapy
- Keywords
- HCC
- Medical subject headings
- Carcinoma, Hepatocellular
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, 200 mg, once daily, until disease progression or toxicity
Brivanib PlaceboOther
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
TACE TherapyProcedure or surgery
Trans-Arterial Chemo-Embolization Therapy
| Study group | Role | What they receive |
|---|---|---|
| Brivanib | Active comparator | Adjuvant treatment with TACE Therapy Receives: Drug: Brivanib; Procedure: TACE Therapy |
| Brivanib Placebo | Placebo comparator | Placebo adjuvant treatment with TACE Therapy Receives: Other: Brivanib Placebo; Procedure: TACE Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
Measured: Survival will be assessed continuously
Secondary outcomes (4)
To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
Measured: Every 8 weeks
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
Measured: Every 8 weeks
To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms
Measured: End of Study
To evaluate the safety of brivanib in combination with TACE
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study start20 Jul 2009
- Primary completion28 Sep 2012
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 734 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908752
- Sponsor's protocol ID
- CA182-037
- Other IDs
- EUDRACT # 2008-008715-26
- Acronym
- BRISK TA
- Status last verified
- Nov 2019
- First submitted
- 22 May 2009
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
- ClinicalTrials.gov ID
- NCT00908752
- Acronym / sponsor ID
- BRISK TA / CA182-037
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 734 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2009 (actual)
- Primary completion
- 28 Sep 2012 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 27 May 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 compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
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 | Active comparator | Drug: Brivanib, Procedure: TACE TherapyAdjuvant treatment with TACE Therapy |
| Brivanib Placebo | Placebo comparator | Other: Brivanib Placebo, Procedure: TACE TherapyPlacebo adjuvant treatment with TACE Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with diagnosis of hepatocellular carcinoma
- Cirrhotic status of Child-Pugh Class A or B with a score of 7
- ECOG performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function
Key exclusion criteria (5 listed)
- Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
- History of cardiac disease
- Active and untreated hepatitis B
- Inability to swallow tablets or untreated malabsorption syndrome
- History of human immunodeficiency virus (HIV) infection
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, 200 mg, once daily, until disease progression or toxicity | Drug | Brivanib |
| Brivanib PlaceboTablets, Oral, 0 mg, once daily, until disease progression or toxicity | Other | Brivanib Placebo |
| TACE TherapyTrans-Arterial Chemo-Embolization Therapy | Procedure or surgery | Brivanib, Brivanib Placebo |
Primary outcome
To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
Time frame: Survival will be assessed continuously
4 secondary outcomes
To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
Time frame: Every 8 weeks
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
Time frame: Every 8 weeks
To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms
Time frame: End of Study
To evaluate the safety of brivanib in combination with TACE
Time frame: Every 8 weeks
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 2 Dec 2019.
- 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.
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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
94 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brivanib and TACE Therapy in people with Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 94 sites in 13 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 4 inclusion and 5 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 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in Japan, China, France, South Korea, United States and 8 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 the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy (time frame: Survival will be assessed continuously). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2019.