Carcinoma, HepatocellularPhase 3BRISK-APSNCT01108705
Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment
A Phase 3 study testing Brivanib in people with Carcinoma, Hepatocellular, run by Bristol-Myers Squibb at 32 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Brivanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 32 sitesin 4 countries
- Study dates
- May 2010to Oct 2013
- 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
- Diagnosis of advanced hepatocellular carcinoma
- Asian ethnicity
- 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 performance status of 0, 1, or 2
- Life expectancy of at least 8 weeks
- Adequate hematologic, hepatic, and renal function
Who cannot join
- Women of childbearing potential 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
- Inability to swallow tablets or untreated malabsorption syndrome
- History of HIV infection
- Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
China26 sites
Local Institution
Beijing, Beijing Municipality, 100021
Local Institution
Beijing, Beijing Municipality, 100071
Local Institution
Beijing, Beijing Municipality, 100853
Local Institution
Changchun, Jilin, 130012
Local Institution
Changchun, Jilin, 130021
Local Institution
Chengdu, Sichuan, 610041
Local Institution
Chongqing, Chongqing Municipality, 400038
Local Institution
Fuzhou, Fujian, 350014
Local Institution
Fuzhou, Fujian, 350025
Local Institution
Guangzhou, Guangdong, 510060
Local Institution
Guangzhou, Guangdong, 510515
Local Institution
Guanzhou, Guangdong, 610080
Local Institution
Hangzhou, Zhejiang, 310022
Local Institution
Hankou, Hubei, 430023
Local Institution
Harbin, Heilongjiang, 150040
Local Institution
Hefei, Anhui, 230022
Local Institution
Nanjing, Jiangsu, 210002
Local Institution
Nanjing, Jiangsu, 210029
Local Institution
Shanghai, Shanghai Municipality, 200032
Local Institution
Shanghai, Shanghai Municipality, 200080
Local Institution
Shenyang, Liaoning, 110001
Local Institution
Suzhou, Jiangsu, 215006
Local Institution
Tianjin, Tianjin Municipality, 300060
Local Institution
Wuhan, Hubei, 430030
Local Institution
Xi'an, 710000
Local Institution
Xi'an, 710038
Taiwan3 sites
Local Institution
Kaohsiung County, 833
Local Institution
Taipei, 11217
Local Institution
Taoyuan, 333
South Korea2 sites
Local Institution
Gyeonggi-do, 410-769
Local Institution
Seoul, 135-710
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 Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib
The purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Brivanib, Placebo
- 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, 800 mg, once daily, until disease progression or toxicity
PlaceboDrug
Tablets, Oral, 0mg, once daily, until disease progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| Brivanib | Experimental | Not described Receives: Drug: Brivanib |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Every 6 weeks for an average of 6 months
Secondary outcomes (4)
Compare time to progression (TTP) using modified RECIST for HCC
Measured: Every 6 weeks
Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC
Measured: Every 6 weeks
Assess duration of response, duration of disease control and time to response
Measured: Every 6 weeks
Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- 87 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
- NCT01108705
- Sponsor's protocol ID
- CA182-047
- Acronym
- BRISK-APS
- Status last verified
- Sep 2015
- First submitted
- 15 Apr 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. 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 Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib
- ClinicalTrials.gov ID
- NCT01108705
- Acronym / sponsor ID
- BRISK-APS / CA182-047
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Apr 2010 (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 whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib 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 | Experimental | Drug: Brivanib |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of advanced hepatocellular carcinoma
- Asian ethnicity
- 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 performance status of 0, 1, or 2
Key exclusion criteria (7 listed)
- Women of childbearing potential 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
- Inability to swallow tablets or untreated malabsorption syndrome
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, 0mg, once daily, until disease progression or toxicity | Drug | Placebo |
Primary outcome
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: Every 6 weeks for an average of 6 months
4 secondary outcomes
Compare time to progression (TTP) using modified RECIST for HCC
Time frame: Every 6 weeks
Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC
Time frame: Every 6 weeks
Assess duration of response, duration of disease control and time to response
Time frame: Every 6 weeks
Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results
Time frame: Every 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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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
32 sites in 4 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 Carcinoma, Hepatocellular, run by Bristol-Myers Squibb at 32 sites in 4 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 7 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: stopped early, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China, Taiwan, South Korea, Singapore. 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 was stopped early. Results are not available in the source record.
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?
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: Every 6 weeks for an average of 6 months). 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 12 Oct 2015.