The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,714
To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
Time frame: Survival will be assessed continuously
To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC
Time frame: Every 6 weeks
To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC
Time frame: Every 6 weeks
To determine duration of response, duration of disease control, and time to response (TTR)
Time frame: Every 6 weeks
To assess the safety profile of brivanib and sorafenib
Time frame: Every 6 weeks
To explore PK and exposure-response in the study population
Time frame: Every 6 weeks
To compare time to symptomatic progression
Time frame: Every 6 weeks
To compare health-related quality of life
Time frame: Every 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Univ Of Ark For Med Sci
Little Rock, Arkansas, United States
Agajanian Institute Of Hematology And Oncology
Downey, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Va Ct Healthcare System
West Haven, Connecticut, United States
Medical Specialists Of Palm Beaches
Lake Worth, Florida, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
3912 Taubman Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Thomas Jefferson Univ.
Philadelphia, Pennsylvania, United States
...and 163 more locations