Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Brivanib; Other: Brivanib Placebo; Procedure: TACE Therapy

• Registration Number: NCT00908752
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Study Start: 2009-07-20
• Primary Completion: 2012-09-28
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Disposition First Posted: 2015-10-12
• Study Completion: 2018-01-26
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 734

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brivanib Placebo	TACE Therapy	Placebo adjuvant treatment with TACE Therapy
Brivanib	Brivanib	Adjuvant treatment with TACE Therapy
Brivanib	TACE Therapy	Adjuvant treatment with TACE Therapy
Brivanib Placebo	Brivanib Placebo	Placebo adjuvant treatment with TACE Therapy

Primary Outcome Measures

Name	Time	Method
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	Survival will be assessed continuously

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

The University Of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Sharp Clinical Oncology Research; 🇺🇸 San Diego, California, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Richard Finn, M.D.; 🇺🇸 Los Angeles, California, United States

University Of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Local Institution; 🇹🇭 Bangkok, Thailand

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States