A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)
18 Years
N/A
Both
Liver Cancer
Trial Information
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)
Inclusion Criteria:
- Histologic or cytologic confirmed diagnosis of HCC
- Advanced disease defined as (i) disease not eligible for surgical or loco-regional
therapy or (ii) disease progressive after surgical or loco-regional therapy
- 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 (ECOG) performance status 0, 1, 2
- Subjects who have a life expectancy of at least 8 weeks
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria:
- women of childbearing potential (WOCBP) 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
- Any other hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events
(CTCAE) Grade 3 within 4 weeks
- Inability to swallow tablets or untreated malabsorption syndrome
- History of human immunodeficiency virus (HIV) infection
- Prior use of systemic investigational agents for HCC (except for Sorafenib)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
To 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
Outcome Time Frame:
computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Brazil: Ministry of Health
Study ID:
CA182-034
NCT ID:
NCT00825955
Start Date:
February 2009
Completion Date:
September 2012
Related Keywords:
- Liver Cancer
- Liver Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| 3912 Taubman Center | Ann Arbor, Michigan 48109-0362 |
| Ohio State University | Columbus, Ohio 43210 |
| McGuire DVAMC | Richmond, Virginia 23249 |
| Pacific Hematology Oncology Associates | San Francisco, California 94115 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| Henry Ford Health System Irb | Detroit, Michigan 48202 |
| Mayo Clinic Arizona | Scottsdale, Arizona 85259 |
| Columbia University Medical Center | New York, New York 10032 |
| Loma Linda University Cancer Center | Loma Linda, California 92354 |
| Oregon Health & Sci Univ | Portland, Oregon 97239 |
| Univ Of Ark For Med Sci | Little Rock, Arkansas 72205 |
| Richard Finn, M.D. | Los Angeles, California 90095 |
| University Of Florida Hepatology | Gainesville, Florida 32610 |
| The University Of Texas Medical School At Houston | Houston, Texas 77030 |
| The University Of Texas Health Science Center | San Antonio, Texas 78229 |
