Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment

Phase 3

Terminated

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: Brivanib; Drug: Placebo

• Registration Number: NCT01108705
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Study Start: 2010-05
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Diagnosis of advanced hepatocellular carcinoma
• Asian ethnicity
• Patient has failed ≥14 days of sorafenib treatment
• Cirrhotic status of Child-Pugh Class A or B with a score of 7
• Eastern Cooperative Oncology Group performance status of 0, 1, or 2
• Life expectancy of at least 8 weeks
• Adequate hematologic, hepatic, and renal function

Key

Exclusion Criteria

• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy
• Previous or concurrent cancer that is distinct in primary site
• History of active cardiac disease
• Thrombotic or embolic events within the past 6 months
• Inability to swallow tablets or untreated malabsorption syndrome
• History of HIV infection
• Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brivanib	Brivanib	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to sorafenib and receive brivanib plus best supportive care (BSC) to those receiving placebo plus BSC	Every 6 weeks for an average of 6 months

Secondary Outcome Measures

Name	Time	Method
Compare time to progression (TTP) using modified RECIST for HCC	Every 6 weeks
Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC	Every 6 weeks
Assess duration of response, duration of disease control and time to response	Every 6 weeks
Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results	Every 6 weeks

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Taoyuan, Taiwan