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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular
Both
Carcinoma, Hepatocellular
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
throughout the study
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA182-015
NCT ID:
NCT00437424
Start Date:
July 2007
Completion Date:
June 2010
Related Keywords:
- Carcinoma, Hepatocellular
- Hepatocellular cancer
- Other advanced solid malignancies
- Carcinoma
- Liver Diseases
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Case Western Reserve University | Cleveland, Ohio 44106 |
| South Texas Accelerated Research Therapeutics, Llc | San Antonio, Texas 78229 |
