Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).

Official Title
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A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Brivanib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm: Brivanib<br> | Drug: Brivanib<br>* Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity<br>* Other names: BMS-582664;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC