Breast Cancer Research Foundation
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
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 ]
Eligibility Criteria
Information from the National Library of Medicine
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
For more information regarding BMS clinical trial participation, please visit BMSStudyConnect.com.
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