Back to resultsDetermine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Brivanib
Sponsored by
About this trial
This is an interventional basic science trial for Hepatocellular Carcinoma focused on measuring 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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm: Brivanib
Arm Description
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax) of Brivanib
Trough observed plasma concentration (Cmin) of Brivanib
Time of maximum observed plasma concentration (Tmax) of Brivanib
Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib
Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib
Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib
Terminal half-life (T-HALF) of Brivanib
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01540461
Brief Title
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
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm: Brivanib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of Brivanib
Time Frame
Days 1, 2, 8, 9 and 15
Title
Trough observed plasma concentration (Cmin) of Brivanib
Time Frame
Days 1, 2, 8, 9 and 15
Title
Time of maximum observed plasma concentration (Tmax) of Brivanib
Time Frame
Days 1, 2, 8, 9 and 15
Title
Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib
Time Frame
Days 1, 2, 8, 9 and 15
Title
Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib
Time Frame
Days 1, 2, 8, 9 and 15
Title
Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib
Time Frame
Days 1, 2, 8, 9 and 15
Title
Terminal half-life (T-HALF) of Brivanib
Time Frame
Days 1, 2, 8, 9 and 15
Title
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
Time Frame
Days 1, 2, 8, 9 and 15
Secondary Outcome Measure Information:
Title
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
Time Frame
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)
Title
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
Time Frame
Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution
City
Ha Erbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
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