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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00437424

Purpose

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	Intervention	Phase
Carcinoma, Hepatocellular	Drug: Brivanib	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: BMS540215 Brivanib alaninate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	July 2007
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Brivanib Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression Other Name: BMS-582664

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437424

Locations

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
Spain
Local Institution
Sevilla, Spain, 41013

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00437424 History of Changes
Other Study ID Numbers:	CA182-015
Study First Received:	February 14, 2007
Last Updated:	May 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Hepatocellular cancer
Other advanced solid malignancies

Additional relevant MeSH terms:

Carcinoma
Liver Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 09, 2012