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

Phase 1

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Brivanib

• Registration Number: NCT01540461
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Study Start: 2012-03
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm: Brivanib	Brivanib	-

Primary Outcome Measures

Name	Time	Method
Time of maximum observed plasma concentration (Tmax) 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
Maximum observed plasma concentration (Cmax) 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
Trough observed plasma concentration (Cmin) of Brivanib	Days 1, 2, 8, 9 and 15
Terminal half-life (T-HALF) 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
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Nanjing, Jiangsu, China