A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
NCT ID: NCT00355238
Last Updated: 2023-12-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2006-12-31
2010-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
no comparator to brivanib
brivanib (active)
Tablet, Oral, Brivanib 800 mg, once daily, until progression
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
brivanib (active)
Tablet, Oral, Brivanib 800 mg, once daily, until progression
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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%
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City Of Hope National Medical Center
Duarte, California, United States
City Of Hope National Medical Center
Duarte, California, United States
Harbor UCLA Medical Center
Los Angeles, California, United States
Harbor-Ucla Medical Center
Los Angeles, California, United States
Christiana Care Health Services
Newark, Delaware, United States
University Of Miami Miller School Of Medicine
Miami, Florida, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
University Of Chicago
Chicago, Illinois, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Wayne State University
Detroit, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Univ Of Texas Southwestern
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Local Institution
Marseille, , France
Local Institution
Reims, , France
Local Institution
Rennes, , France
Local Institution
Villejuif, , France
Local Institution
Shatin, Nt.,, , Hong Kong
Local Institution
Kampung Baharu Nilai, Negeri Sembilan, Malaysia
Local Institution
Kuala Lumpur, , Malaysia
Local Institution
Cebu City, , Philippines
Local Institution
Davao City, , Philippines
Local Institution
Quezon, , Philippines
Local Institution
Singapore, , Singapore
Local Institution
Singapore, , Singapore
Local Institution
Gyeonggi-do, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Tainan City, , Taiwan
Local Institution
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA182-006
Identifier Type: -
Identifier Source: org_study_id