Status:
COMPLETED
Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Histologic or cytologic confirmed diagnosis of HCC
- Advanced disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy
- Patient has failed ≥ 14 days of Sorafenib treatment
- Cirrhotic status of Child-Pugh Class A or B with a score of 7
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- Subjects who have a life expectancy of at least 8 weeks
- Adequate hematologic, hepatic, and renal function
Exclusion
- women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy
- Previous or concurrent cancer that is distinct in primary site
- History of active cardiac disease
- Thrombotic or embolic events within the past 6 months
- Any other hemorrhage/bleeding event \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks
- Inability to swallow tablets or untreated malabsorption syndrome
- History of human immunodeficiency virus (HIV) infection
- Prior use of systemic investigational agents for HCC (except for Sorafenib)
Key Trial Info
Start Date :
February 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2017
Estimated Enrollment :
587 Patients enrolled
Trial Details
Trial ID
NCT00825955
Start Date
February 17 2009
End Date
August 25 2017
Last Update
October 9 2019
Active Locations (113)
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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
Loma Linda University Cancer Center
Loma Linda, California, United States, 92350
4
Richard Finn, M.D.
Los Angeles, California, United States, 90095-7077