Hepatocellular Carcinoma (HCC)Phase 2NCT00355238
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
A Phase 2 study testing brivanib (active) in people with Hepatocellular Carcinoma (HCC), run by Bristol-Myers Squibb at 37 sites in 8 countries.
Trial summary
The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- brivanib (active)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 37 sitesin 8 countries
- Study dates
- 31 Dec 2006to 30 Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 hepatocellular carcinoma (HCC) ≥ 2cm based on:
- Biopsy OR
- Radiological evidence of HCC by contrast-enhanced CT scan or contrast-enhanced AND
- Blood test positive for Hepatitis B or C AND
- Alpha fetoprotein above > 400 mg/L
- Not appropriate for curative surgery
- Screening Blood Pressure <150/100 mmHg, Left Ventricular Ejection Fraction (LVEF) >50%
Who cannot join
- Heart Attack within 12 months, uncontrolled chest pain within 6 months
- Ascites resistant to diuretic medication therapy
- Portal-systemic encephalopathy
- Portal hypertension with bleeding esophageal or gastric varices within the past 2 months
- Deficiency of sodium in the blood with sodium < 125 mEq/L
- Subjects with serious non-healing wounds, ulcers or bone fractures
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
United States19 sites
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, 60611
University Of Chicago
Chicago, Illinois, 60637
Univ Of Texas Southwestern
Dallas, Texas, 75390
Wayne State University
Detroit, Michigan, 48201
City Of Hope National Medical Center
Duarte, California, 91010-3000
City Of Hope National Medical Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Md Anderson Cancer Center
Houston, Texas, 77030
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
Harbor UCLA Medical Center
Los Angeles, California, 90095-1678
Harbor-Ucla Medical Center
Los Angeles, California, 90095
University Of Miami Miller School Of Medicine
Miami, Florida, 33136
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Christiana Care Health Services
Newark, Delaware, 19713
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Saint Louis University
St Louis, Missouri, 63104
France4 sites
Local Institution
Marseille, 13273
Local Institution
Reims, 51092
Local Institution
Rennes, 35042
Local Institution
Villejuif, 94805
South Korea4 sites
Local Institution
Gyeonggi-do, 410-769
Local Institution
Seoul, 135-710
Local Institution
Seoul, 138-736
Local Institution
Seoul, 152-703
Philippines3 sites
Local Institution
Cebu City, 6000
Local Institution
Davao City, 8000
Local Institution
Quezon, 1102
Malaysia2 sites
Local Institution
Kampung Baharu Nilai, Negeri Sembilan, 71800
Local Institution
Kuala Lumpur, 56000
Singapore2 sites
Local Institution
Singapore, 169610
Local Institution
Singapore, 308433
About this study
Official title: A Phase II Open Label Study of Brivanib (BMS582664), Administered Orally At A Dose of 800 mg Daily In Subjects With Unresectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regimen of Angiogenesis Inhibitor Therapy
The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- brivanib (active)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brivanib (active)Drug
Also called BMS-582664
Tablet, Oral, Brivanib 800 mg, once daily, until progression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | no comparator to brivanib Receives: Drug: brivanib (active) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A
The percent of participants who have not progressed or died prior to 6 months from the date of their first dose. Participants who have neither progressed nor died but had their last tumor assessment prior to 6 months will not be categorized as progression free and will not be included. Tumor response was measured by the IRRC using mWHO criteria.
Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline.
Measured: From first dose up to approximately 6 months after first dose
The Number of Participants Experiencing Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment.
Measured: From first dose up to 30 days post last dose (up to approximately 34 months)
Secondary outcomes (8)
Tumor Response Rate Per Independent Response Review Committee (IRRC)
The percent of participants whose best overall response is a partial response (PR) or complete response (CR). Tumor measurements by CT/ MRI of the chest, abdomen and pelvis will be obtained at pre-treatment (within 28 days prior to the start of treatment) and every 6 weeks.
Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later.
Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later.
Measured: From first dose to the date of the first documented response (up to approximately 34 months)
Disease Control Rate Per Independent Response Review Committee (IRRC)
The percent of participants whose best response is a partial response (PR), complete response (CR) or stable disease (SD).
Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later.
Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later.
Stable Disease (SD): A decrease of 50% or more or an increase of 25% or more in the sum of all index lesion areas compared to baseline cannot be established. There can be no appearance of new lesions. Documentation must occur 6 weeks (42 days) or more from the baseline determination.
Measured: From first dose to the date of the first documented response (up to approximately 34 months)
Overall Survival for Participants With No Prior Systemic Therapy
The time (in months) from first dosing until the date of death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.
Measured: From first dose to the date of death (up to approximately 34 months)
Overall Survival for Participants With One Prior Angiogenesis Inhibitor Therapy
The time (in months) from first dosing until the date of death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.
Measured: From first dose to the date of death (up to approximately 34 months)
Progression Free Survival (PFS) Per Independent Response Review Committee (IRRC)
The time (in months) from first dosing date to the date of progression per IRRC. Participants who die without a reported prior progression will be considered to have progressed on their date of death (as found in the BMS clinical database). Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who have only baseline tumor assessment will be censored on the first dosing date.
Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline.
Measured: From first dose to the date of the first documented progression (up to approximately 34 months)
Time to Response Per Independent Response Review Committee (IRRC)
The time from the first dose of study therapy until measurement criteria are first met for Partial response (PR) or complete response (CR), whichever is recorded first.
Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later.
Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later.
Measured: From first dose to the date of the first documented response (up to approximately 34 months)
Duration of Response Per Independent Response Review Committee (IRRC)
Duration of response will be computed as from time measurement criteria are met for PR or CR until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline.
Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later.
Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later.
Measured: From first dose to the date of documented progressive disease or death (up to approximately 34 months)
Change From Baseline to End of Treatment in FHSI-8 Total Score
FHSI-8 (Functional Assessment of Cancer Therapy, Hepatobiliary, Symptom Index) was used to assess HCC-related symptoms. The FHSI-8 includes eight items representing HCC-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms.
Measured: Baseline and end of treatment (up to approximately 33 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study start31 Dec 2006
- Primary completion30 Apr 2010
- Study completion30 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 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
- NCT00355238
- Sponsor's protocol ID
- CA182-006
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2006
- Last updated
- 1 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Park JW, Finn RS, Kim JS, Karwal M, Li RK, Ismail F, Thomas M, Harris R, Baudelet C, Walters I, Raoul JL. Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1973-83. doi: 10.1158/1078-0432.CCR-10-2011. Epub 2011 Feb 24.
PubMed 21349999
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Study of Brivanib (BMS582664), Administered Orally At A Dose of 800 mg Daily In Subjects With Unresectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regimen of Angiogenesis Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT00355238
- Acronym / sponsor ID
- CA182-006
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2006 (actual)
- Primary completion
- 30 Apr 2010 (actual)
- Study completion
- 30 Apr 2010 (actual)
- First posted
- 21 Jul 2006 (estimated)
- Results
- Posted 1 Dec 2023
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 clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: brivanib (active)no comparator to brivanib |
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 hepatocellular carcinoma (HCC) ≥ 2cm based on:
- Biopsy OR
- Radiological evidence of HCC by contrast-enhanced CT scan or contrast-enhanced AND
- Blood test positive for Hepatitis B or C AND
- Alpha fetoprotein above > 400 mg/L
Key exclusion criteria (6 listed)
- Heart Attack within 12 months, uncontrolled chest pain within 6 months
- Ascites resistant to diuretic medication therapy
- Portal-systemic encephalopathy
- Portal hypertension with bleeding esophageal or gastric varices within the past 2 months
- Deficiency of sodium in the blood with sodium < 125 mEq/L
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 |
|---|---|---|
| brivanib (active)Also: BMS-582664Tablet, Oral, Brivanib 800 mg, once daily, until progression | Drug | 1 |
Primary outcome
Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A
Time frame: From first dose up to approximately 6 months after first dose
The percent of participants who have not progressed or died prior to 6 months from the date of their first dose. Participants who have neither progressed nor died but had their last tumor assessment prior to 6 months will not be categorized as progression free and will not be included. Tumor response was measured by the IRRC using mWHO criteria. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline.
The Number of Participants Experiencing Adverse Events (AEs)
Time frame: From first dose up to 30 days post last dose (up to approximately 34 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment.
8 secondary outcomes
Tumor Response Rate Per Independent Response Review Committee (IRRC)
Time frame: From first dose to the date of the first documented response (up to approximately 34 months)
Disease Control Rate Per Independent Response Review Committee (IRRC)
Time frame: From first dose to the date of the first documented response (up to approximately 34 months)
Overall Survival for Participants With No Prior Systemic Therapy
Time frame: From first dose to the date of death (up to approximately 34 months)
Overall Survival for Participants With One Prior Angiogenesis Inhibitor Therapy
Time frame: From first dose to the date of death (up to approximately 34 months)
Progression Free Survival (PFS) Per Independent Response Review Committee (IRRC)
Time frame: From first dose to the date of the first documented progression (up to approximately 34 months)
Time to Response Per Independent Response Review Committee (IRRC)
Time frame: From first dose to the date of the first documented response (up to approximately 34 months)
Duration of Response Per Independent Response Review Committee (IRRC)
Time frame: From first dose to the date of documented progressive disease or death (up to approximately 34 months)
Change From Baseline to End of Treatment in FHSI-8 Total Score
Time frame: Baseline and end of treatment (up to approximately 33 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21349999Park JW, Finn RS, Kim JS, Karwal M, Li RK, Ismail F, Thomas M, Harris R, Baudelet C, Walters I, Raoul JL. Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1973-83. doi: 10.1158/1078-0432.CCR-10-2011. Epub 2011 Feb 24.
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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
37 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brivanib (active) in people with Hepatocellular Carcinoma (HCC), run by Bristol-Myers Squibb at 37 sites in 8 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 6 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, France, South Korea, Philippines, Malaysia and 3 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A (time frame: From first dose up to approximately 6 months after first dose). The study lists 2 primary outcomes in all. 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 NCT00355238, which also lists 1 linked publication.
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 1 Dec 2023.