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Completed

NCT Number: NCT00437424

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

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

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Seville, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivanib

Drug

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

Other names: BMS-582664

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 21, 2007
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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