Hepatocellular Carcinoma
Conditions
Keywords
HCC
Brief summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).
Interventions
DRUGBrivanib
Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accumulation index calculated as the ratio: AUC(TAU) at steady-state (Day 8) divided by AUC(TAU) after the first dose (Day 1) [AI] of Brivanib | Days 1, 2, 8, 9 and 15 |
| Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib | Days 1, 2, 8, 9 and 15 |
| Terminal half-life (T-HALF) of Brivanib | Days 1, 2, 8, 9 and 15 |
| Maximum observed plasma concentration (Cmax) of Brivanib | Days 1, 2, 8, 9 and 15 |
| Trough observed plasma concentration (Cmin) of Brivanib | Days 1, 2, 8, 9 and 15 |
| Time of maximum observed plasma concentration (Tmax) of Brivanib | Days 1, 2, 8, 9 and 15 |
| Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib | Days 1, 2, 8, 9 and 15 |
| Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib | Days 1, 2, 8, 9 and 15 |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary evidence of anti-tumor activity as measured by objective response rate (ORR) and disease control rate (DCR) in Chinese subjects with advanced HCC treated with Brivanib | Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months) |
| Safety assessments based on adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), 2-D Echocardiograms, physical examinations and clinical laboratory tests | Part A: Day 1-Week 1, Day 8-Week 2, Day 15-Week 3 and Day 29-Week 5, Part B: End of treatment (approximately 24 months) |
Countries
China
Outcome results
None listed