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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00437424
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : May 4, 2011
Information provided by:
Bristol-Myers Squibb

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
Carcinoma, Hepatocellular Drug: Brivanib Phase 1

Study Type : Interventional  (Clinical Trial)
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 : July 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: 1 Drug: Brivanib
Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression
Other Name: BMS-582664

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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: every 6 weeks until disease progression ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00437424

United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Ohio
Case Western Reserve University
Clleveland, Ohio, United States, 44106
United States, Texas
South Texas Accelerated Research Therapeutics, Llc
San Antonio, Texas, United States, 78229
Local Institution
Sevilla, Spain, 41013
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00437424     History of Changes
Other Study ID Numbers: CA182-015
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2011

Keywords provided by Bristol-Myers Squibb:
Hepatocellular cancer
Other advanced solid malignancies

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases