The purpose of this study is 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
734
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Trans-Arterial Chemo-Embolization Therapy
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
Time frame: Survival will be assessed continuously
To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
Time frame: Every 8 weeks
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
Time frame: Every 8 weeks
To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms
Time frame: End of Study
To evaluate the safety of brivanib in combination with TACE
Time frame: Every 8 weeks
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Richard Finn, M.D.
Los Angeles, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Montefiore Medical Center
The Bronx, New York, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States
University Of Virginia Health System
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Buenos Aires, Argentina
Local Institution
Parkville, Victoria, Australia
...and 84 more locations