Carcinoma, Hepatocellular
Conditions
Keywords
Hepatocellular cancer, Other advanced solid malignancies
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
Interventions
DRUGBrivanib
Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain, United States
Outcome results
None listed