Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm: Brivanib

Group Type EXPERIMENTAL

Brivanib

Intervention Type DRUG

Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity

Interventions

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Brivanib

Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity

Intervention Type DRUG

Other Intervention Names

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BMS-582664

Eligibility Criteria

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Inclusion Criteria

Subjects with:

* Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
* Not having received prior systemic treatment for advanced HCC
* Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

Subjects with:

* Brain metastasis or evidence of leptomeningeal disease
* History of impaired brain function (encephalopathy) or active heart disease
* Unmanageable fluid in the abdomen (ascites)
* Bleeding esophageal or gastric varices within 2 months prior to inclusion

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No