Status:
COMPLETED
First Line Hepato Cellular Carcinoma (HCC)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepato Cellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Histologic or cytologic confirmed diagnosis of HCC.
- Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
- Child-Pugh Class A
- ECOG performance status 0-1
- Adequate hematologic, hepatic, and renal function
Exclusion
- Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
- History of active cardiac disease
- Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
- Any other hemorrhage/bleeding event \>= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
- Inability to swallow tablets or untreated malabsorption syndrome
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
1714 Patients enrolled
Trial Details
Trial ID
NCT00858871
Start Date
May 1 2009
End Date
September 1 2013
Last Update
October 17 2016
Active Locations (173)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Univ Of Ark For Med Sci
Little Rock, Arkansas, United States, 72205
3
Agajanian Institute Of Hematology And Oncology
Downey, California, United States, 90241
4
Sharp Clinical Oncology Research
San Diego, California, United States, 92123