A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
18 Years
N/A
Both
Hepato Cellular Carcinoma (HCC)
Trial Information
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Inclusion Criteria:
- Histologic or cytologic confirmed diagnosis of HCC.
- Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR
progressive disease after surgical and/or locoregional therapies
- Child-Pugh Class A
- ECOG performance status 0-1
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria:
- Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular
targeted agents for HCC
- History of active cardiac disease
- Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
- Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for
esophageal or gastric varices
- Inability to swallow tablets or untreated malabsorption syndrome
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 the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
Outcome Time Frame:
Survival will be assessed continuously
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study ID:
CA182-033
NCT ID:
NCT00858871
Start Date:
May 2009
Completion Date:
December 2012
Related Keywords:
- Hepato Cellular Carcinoma (HCC)
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| 3912 Taubman Center | Ann Arbor, Michigan 48109-0362 |
| McGuire DVAMC | Richmond, Virginia 23249 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Wisconsin | Madison,, Wisconsin 53792-5666 |
| Mayo Clinic Arizona | Scottsdale, Arizona 85259 |
| Medical Specialists Of Palm Beaches | Lake Worth, Florida 33467 |
| Univ Of Ark For Med Sci | Little Rock, Arkansas 72205 |
| Agajanian Institute Of Hematology And Oncology | Downey, California 90241 |
| Va Ct Healthcare System | West Haven, Connecticut 06516 |
| Pennsylvania Oncology/Hematology Associates | Philadelphia, Pennsylvania 19106 |
| Thomas Jefferson Univ. | Philadelphia, Pennsylvania 19107 |
