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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Other: Brivanib Placebo; Procedure: TACE Therapy; Drug: Brivanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00908752

CA182-037

EUDRACT # 2008-008715-26

Details and patient eligibility

About

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.

Enrollment: 734 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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734 participants in 2 patient groups, including a placebo group

Brivanib

Active Comparator group

Description:

Adjuvant treatment with TACE Therapy

Treatment:

Procedure: TACE Therapy

Drug: Brivanib

Brivanib Placebo

Placebo Comparator group

Description:

Placebo adjuvant treatment with TACE Therapy

Treatment:

Procedure: TACE Therapy

Other: Brivanib Placebo