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Completed

NCT Number: NCT00908752

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivanib

Drug

Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

Other names: BMS-582664

Brivanib Placebo

Other

Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

TACE Therapy

Procedure

Trans-Arterial Chemo-Embolization Therapy

Primary outcomes

  1. 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

  1. 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

  2. To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms

    Time frame: Every 8 weeks

  3. 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

  4. To evaluate the safety of brivanib in combination with TACE

    Time frame: Every 8 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Acronym: BRISK TA

Important dates

Study start
2009
Primary completion
2012
Study completion
2018
First posted
May 27, 2009
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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