A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
18 Years
N/A
Both
Hepatocellular Carcinoma
Trial Information
A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
Inclusion Criteria:
- Patients with diagnosis of hepatocellular carcinoma
- Cirrhotic status of Child-Pugh Class A or B with a score of 7
- ECOG performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function
Exclusion criteria:
- Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or
molecular targeted agents for HCC
- History of cardiac disease
- Active and untreated hepatitis B
- Inability to swallow tablets or untreated malabsorption syndrome
- History of human immunodeficiency virus (HIV) infection
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 (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
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:
CA182-037
NCT ID:
NCT00908752
Start Date:
February 1920
Completion Date:
March 2015
Related Keywords:
- Hepatocellular Carcinoma
- HCC
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Virginia Health System | Charlottesville, Virginia 22903 |
| Richard Finn, M.D. | Los Angeles, California 90095 |
| The University Of Texas Medical School At Houston | Houston, Texas 77030 |
| Vanderbilt University Med Ctr | Nashville, Tennessee 37232 |
