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Clinical Trials/NCT00908752
NCT00908752CompletedPhase 3

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)

Bristol-Myers Squibb8 sites in 2 countries734 target enrollmentStarted: July 20, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
734
Locations
8
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Brivanib Placebo

Placebo Comparator

Placebo adjuvant treatment with TACE Therapy

Intervention: Brivanib Placebo (Other)

Brivanib

Active Comparator

Adjuvant treatment with TACE Therapy

Intervention: Brivanib (Drug)

Brivanib

Active Comparator

Adjuvant treatment with TACE Therapy

Intervention: TACE Therapy (Procedure)

Brivanib Placebo

Placebo Comparator

Placebo adjuvant treatment with TACE Therapy

Intervention: TACE Therapy (Procedure)

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

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