Trial Information
A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)
Inclusion Criteria:
Subjects with:
- Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
- Not having received prior systemic treatment for advanced HCC
- Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score
of ≤ 7))
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
Subjects with:
- Brain metastasis or evidence of leptomeningeal disease
- History of impaired brain function (encephalopathy) or active heart disease
- Unmanageable fluid in the abdomen (ascites)
- Bleeding esophageal or gastric varices within 2 months prior to inclusion
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Maximum observed plasma concentration (Cmax) of Brivanib
Outcome Time Frame:
Days 1, 2, 8, 9 and 15
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:
CA182-064
NCT ID:
NCT01540461
Start Date:
April 2012
Completion Date:
August 2013
Related Keywords:
- Hepatocellular Carcinoma
- HCC
- Carcinoma
- Carcinoma, Hepatocellular