The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
587
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Trans-Arterial Chemo-Embolization (TACE) Therapy
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
Time frame: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death
To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)
Time frame: 35 months
To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria
Time frame: 35 months
To assess duration of response, duration of disease control and time to response
Time frame: 6 weeks
To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review
Time frame: 35 months
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Univ Of Ark For Med Sci
Little Rock, Arkansas, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Richard Finn, M.D.
Los Angeles, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
UF Health Clinical Research Center
Gainesville, Florida, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
3912 Taubman Center
Ann Arbor, Michigan, United States
Henry Ford Health System Irb
Detroit, Michigan, United States
...and 103 more locations