Hepatocellular CarcinomaPhase 1NCT01540461
Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
A Phase 1 study testing Brivanib in people with Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 3 sites in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC). 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2012to Nov 2013
- Phase
- Phase 1
- 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
- Subjects with:
- Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
- Not having received prior systemic treatment for advanced HCC
- Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Who cannot join
- Subjects with:
- Brain metastasis or evidence of leptomeningeal disease
- History of impaired brain function (encephalopathy) or active heart disease
- Unmanageable fluid in the abdomen (ascites)
- Bleeding esophageal or gastric varices within 2 months prior to inclusion
Trial locations and contacts
3 sites in 1 country.
China3 sites
Local Institution
Beijing, Beijing Municipality, 100071
Local Institution
Harbin, Heilongjiang, 150040
Local Institution
Nanjing, Jiangsu, 210002
About this study
Official title: A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Brivanib
- 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, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Arm: Brivanib | Experimental | Not described Receives: Drug: Brivanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of Brivanib
Measured: Days 1, 2, 8, 9 and 15
Trough observed plasma concentration (Cmin) of Brivanib
Measured: Days 1, 2, 8, 9 and 15
Time of maximum observed plasma concentration (Tmax) of Brivanib
Measured: Days 1, 2, 8, 9 and 15
Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib
Measured: Days 1, 2, 8, 9 and 15
Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib
Measured: Days 1, 2, 8, 9 and 15
Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib
Measured: Days 1, 2, 8, 9 and 15
Terminal half-life (T-HALF) of Brivanib
Measured: Days 1, 2, 8, 9 and 15
Accumulation index calculated as the ratio: AUC(TAU) at steady-state (Day 8) divided by AUC(TAU) after the first dose (Day 1) [AI] of Brivanib
Measured: Days 1, 2, 8, 9 and 15
Secondary outcomes (2)
Safety assessments based on adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), 2-D Echocardiograms, physical examinations and clinical laboratory tests
Measured: Part A: Day 1-Week 1, Day 8-Week 2, Day 15-Week 3 and Day 29-Week 5, Part B: End of treatment (approximately 24 months)
Preliminary evidence of anti-tumor activity as measured by objective response rate (ORR) and disease control rate (DCR) in Chinese subjects with advanced HCC treated with Brivanib
Measured: Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2013
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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT01540461
- Sponsor's protocol ID
- CA182-064
- Status last verified
- Jun 2014
- First submitted
- 23 Feb 2012
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT01540461
- Acronym / sponsor ID
- CA182-064
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Feb 2012 (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 evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm: Brivanib | Experimental | Drug: Brivanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
- Not having received prior systemic treatment for advanced HCC
- Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (5 listed)
- Brain metastasis or evidence of leptomeningeal disease
- History of impaired brain function (encephalopathy) or active heart disease
- Unmanageable fluid in the abdomen (ascites)
- Bleeding esophageal or gastric varices within 2 months prior to inclusion
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 withdrawal of consent, disease progression or until unmanageable toxicity | Drug | Arm: Brivanib |
Primary outcome
Maximum observed plasma concentration (Cmax) of Brivanib
Time frame: Days 1, 2, 8, 9 and 15
Trough observed plasma concentration (Cmin) of Brivanib
Time frame: Days 1, 2, 8, 9 and 15
Time of maximum observed plasma concentration (Tmax) of Brivanib
Time frame: Days 1, 2, 8, 9 and 15
Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib
Time frame: Days 1, 2, 8, 9 and 15
Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib
Time frame: Days 1, 2, 8, 9 and 15
Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib
Time frame: Days 1, 2, 8, 9 and 15
Terminal half-life (T-HALF) of Brivanib
Time frame: Days 1, 2, 8, 9 and 15
Accumulation index calculated as the ratio: AUC(TAU) at steady-state (Day 8) divided by AUC(TAU) after the first dose (Day 1) [AI] of Brivanib
Time frame: Days 1, 2, 8, 9 and 15
2 secondary outcomes
Safety assessments based on adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), 2-D Echocardiograms, physical examinations and clinical laboratory tests
Time frame: Part A: Day 1-Week 1, Day 8-Week 2, Day 15-Week 3 and Day 29-Week 5, Part B: End of treatment (approximately 24 months)
Preliminary evidence of anti-tumor activity as measured by objective response rate (ORR) and disease control rate (DCR) in Chinese subjects with advanced HCC treated with Brivanib
Time frame: Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 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 8 Jul 2014.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brivanib in people with Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 3 sites in China.
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 5 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum observed plasma concentration (Cmax) of Brivanib (time frame: Days 1, 2, 8, 9 and 15). The study lists 8 primary outcomes in all. 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 8 Jul 2014.