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

Carcinoma, Hepatocellular Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437424
• Other study ID #: CA182-015
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2007
• Last updated: May 3, 2011
• Start date: July 2007
• Est. completion date: June 2010

Study information

• Verified date: May 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

Drug:
• Brivanib
Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression

Locations

Country	Name	City	State
Spain	Local Institution	Sevilla
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Case Western Reserve University	Clleveland	Ohio
United States	Usc/Norris Comprehensive Cancer Center	Los Angeles	California
United States	South Texas Accelerated Research Therapeutics, Llc	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form