A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction
- Registration Number
- NCT00437424
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Subjects with a biopsy proven advanced solid tumor
- Subjects with a biopsy proven diagnosis of hepatocellular carcinoma conforming to child pugh classifications A, B, or C
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Brivanib -
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine the effect of BMS-582664 on subjects with varying levels of hepatic impairment and guide prescribers with regards to dosing in specialized populations throughout the study
- Secondary Outcome Measures
Name Time Method To assess safety and tolerability of BMS-582664 in subjects with HCC with mild, moderate, and severe hepatic impairment and in subjects with advanced malignancies with normal hepatic function by Day 1 and Day 28 Pharmacokinetics To assess efficacy of BMS-582664 in subjects with advanced solid tumor malignancies and subjects with HCC by CT or MRI every 6 weeks until disease progression
Trial Locations
- Locations (5)
Local Institution
🇪🇸Sevilla, Spain
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Usc/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Case Western Reserve University
🇺🇸Clleveland, Ohio, United States
South Texas Accelerated Research Therapeutics, Llc
🇺🇸San Antonio, Texas, United States