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A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00437424
Collaborator
(none)
24
Enrollment
5
Locations
1
Arm
35
Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pharmacokinetic Study of Brivanib (BMS-582664) in Subjects With Advanced Solid Tumor Malignancies and Normal Hepatic Function or Hepatocellular Carcinoma With Impaired Hepatic Function
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Brivanib
Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression
Other Names:
  • BMS-582664

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The primary objective of this study is to determine the effect of BMS-582664 on subjects with varying levels of hepatic impairment and guide prescribers with regards to dosing in specialized populations [throughout the study]

    Secondary Outcome Measures

    1. To assess safety and tolerability of BMS-582664 in subjects with HCC with mild, moderate, and severe hepatic impairment and in subjects with advanced malignancies with normal hepatic function [by Day 1 and Day 28 Pharmacokinetics]

    2. To assess efficacy of BMS-582664 in subjects with advanced solid tumor malignancies and subjects with HCC by CT or MRI [every 6 weeks until disease progression]

    Eligibility Criteria

    Criteria

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

    • Subjects with a biopsy proven advanced solid tumor

    • Subjects with a biopsy proven diagnosis of hepatocellular carcinoma conforming to child pugh classifications A, B, or C

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Alabama At Birmingham Birmingham Alabama United States 35294
    2 Usc/Norris Comprehensive Cancer Center Los Angeles California United States 90033
    3 Case Western Reserve University Clleveland Ohio United States 44106
    4 South Texas Accelerated Research Therapeutics, Llc San Antonio Texas United States 78229
    5 Local Institution Sevilla Spain 41013

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00437424
    Other Study ID Numbers:
    • CA182-015
    First Posted:
    Feb 21, 2007
    Last Update Posted:
    May 4, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    Hepatocellular cancer
    Other advanced solid malignancies
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of May 4, 2011