Clincosm LogoSign in Get a demo

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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01540461
Collaborator
(none)
17
Enrollment
3
Locations
1
Arm
20
Duration (Months)
5.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm: Brivanib

Drug: Brivanib
Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity
Other Names:
  • BMS-582664

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) of Brivanib [Days 1, 2, 8, 9 and 15]

    2. Trough observed plasma concentration (Cmin) of Brivanib [Days 1, 2, 8, 9 and 15]

    3. Time of maximum observed plasma concentration (Tmax) of Brivanib [Days 1, 2, 8, 9 and 15]

    4. 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]

    5. Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib [Days 1, 2, 8, 9 and 15]

    6. Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib [Days 1, 2, 8, 9 and 15]

    7. Terminal half-life (T-HALF) of Brivanib [Days 1, 2, 8, 9 and 15]

    8. 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

    1. 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)]

    2. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Beijing Beijing China 100071
    2 Local Institution Ha Erbin Heilongjiang China 150040
    3 Local Institution Nanjing Jiangsu China 210002

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01540461
    Other Study ID Numbers:
    • CA182-064
    First Posted:
    Feb 28, 2012
    Last Update Posted:
    Jul 8, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Bristol-Myers Squibb
    HCC
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Jul 8, 2014