Clinical trial NCT01540461: Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
Official title: A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-02-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of Brivanib
timeFrame: Days 1, 2, 8, 9 and 15
measure: Trough observed plasma concentration (Cmin) of Brivanib
timeFrame: Days 1, 2, 8, 9 and 15
measure: Time of maximum observed plasma concentration (Tmax) of Brivanib
timeFrame: Days 1, 2, 8, 9 and 15
measure: Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib
timeFrame: Days 1, 2, 8, 9 and 15
measure: Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib
timeFrame: Days 1, 2, 8, 9 and 15
measure: Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib
timeFrame: Days 1, 2, 8, 9 and 15
measure: Terminal half-life (T-HALF) of Brivanib
timeFrame: Days 1, 2, 8, 9 and 15
measure: 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
timeFrame: Days 1, 2, 8, 9 and 15
Secondary outcomes:
measure: 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
timeFrame: 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)
measure: 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
timeFrame: Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Ha Erbin
country: China
facility: Local Institution
state: Heilongjiang
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: