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

Bristol-Myers Squibb24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Hepatocellular

Interventions

BrivanibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

University Of Alabama At Birmingham

Birmingham, Alabama, United States

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Case Western Reserve University

Clleveland, Ohio, United States

South Texas Accelerated Research Therapeutics, Llc

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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 Outcomes

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

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

Data from ClinicalTrials.gov

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