Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments brivanib, brivanib placebo, tace therapy
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date July 2009
End date September 2012
Trial size 870 participants
Trial identifier NCT00908752, CA182-037, EUDRACT # 2008-008715-26

Summary

The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Adjuvant treatment with TACE Therapy
brivanib BMS-582664
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
tace therapy
Trans-Arterial Chemo-Embolization Therapy
(Placebo Comparator)
Placebo adjuvant treatment with TACE Therapy
brivanib placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
tace therapy
Trans-Arterial Chemo-Embolization Therapy

Primary Outcomes

Measure
To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
time frame: Survival will be assessed continuously

Secondary Outcomes

Measure
To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
time frame: Every 8 weeks
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
time frame: Every 8 weeks
To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms
time frame: End of Study
To evaluate the safety of brivanib in combination with TACE
time frame: Every 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Patients with diagnosis of hepatocellular carcinoma - Cirrhotic status of Child-Pugh Class A or B with a score of 7 - ECOG performance status of 0 or 1 - Adequate hematologic, hepatic, and renal function Exclusion criteria: - Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC - History of cardiac disease - Active and untreated hepatitis B - Inability to swallow tablets or untreated malabsorption syndrome - History of human immunodeficiency virus (HIV) infection

Additional Information

Official title A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.