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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00437424
First received: February 14, 2007
Last updated: May 3, 2011
Last verified: May 2011

February 14, 2007
May 3, 2011
July 2007
June 2010   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00437424 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
  • 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
Not Provided
Not Provided
 
A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Hepatocellular
Drug: Brivanib
Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression
Other Name: BMS-582664
Experimental: 1
Intervention: Drug: Brivanib
El-Khoueiry A, Posey JA, Castillo Ferrando JR, Krishnamurthi SS, Syed S, Kollia G, Walters I, Fischer BS, Masson E. The effects of liver impairment on the pharmacokinetics of brivanib, a dual inhibitor of fibroblast growth factor receptor and vascular endothelial growth factor receptor tyrosine kinases. Cancer Chemother Pharmacol. 2013 Jul;72(1):53-64. doi: 10.1007/s00280-013-2168-z. Epub 2013 May 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain
 
NCT00437424
CA182-015
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP