A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction
A Pharmacokinetic Study of Brivanib (BMS-582664) in Subjects With Advanced Solid Tumor Malignancies and Normal Hepatic Function or Hepatocellular Carcinoma With Impaired Hepatic Function
1 other identifier
interventional
24
2 countries
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2007
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedMay 4, 2011
May 1, 2011
2.9 years
February 14, 2007
May 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
1
EXPERIMENTALInterventions
Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Case Western Reserve University
Clleveland, Ohio, 44106, United States
South Texas Accelerated Research Therapeutics, Llc
San Antonio, Texas, 78229, United States
Local Institution
Seville, 41013, Spain
Related Publications (1)
El-Khoueiry A, Posey JA, Castillo Ferrando JR, Krishnamurthi SS, Syed S, Kollia G, Walters I, Fischer BS, Masson E. The effects of liver impairment on the pharmacokinetics of brivanib, a dual inhibitor of fibroblast growth factor receptor and vascular endothelial growth factor receptor tyrosine kinases. Cancer Chemother Pharmacol. 2013 Jul;72(1):53-64. doi: 10.1007/s00280-013-2168-z. Epub 2013 May 30.
PMID: 23719718DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 14, 2007
First Posted
February 21, 2007
Study Start
July 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
May 4, 2011
Record last verified: 2011-05