Status:
COMPLETED
Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.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
Exclusion
Key Trial Info
Start Date :
July 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2018
Estimated Enrollment :
734 Patients enrolled
Trial Details
Trial ID
NCT00908752
Start Date
July 20 2009
End Date
January 26 2018
Last Update
December 2 2019
Active Locations (94)
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1
Richard Finn, M.D.
Los Angeles, California, United States, 90095
2
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
3
Montefiore Medical Center
The Bronx, New York, United States, 10467-2401
4
Rhode Island Hospital
Providence, Rhode Island, United States, 02903