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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00908752
First received: May 22, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Brivanib
Drug: Brivanib Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the safety of brivanib in combination with TACE [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 870
Study Start Date: July 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brivanib Drug: Brivanib
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664
Placebo Comparator: Brivanib Placebo Drug: Brivanib Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908752

  Show 94 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00908752     History of Changes
Other Study ID Numbers: CA182-037, EUDRACT # 2008-008715-26
Study First Received: May 22, 2009
Last Updated: July 14, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hong Kong: Department of Health
Italy: Istituto Superiore de Sanita (ISS)
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Taiwan: Department of Health
Thailand: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 22, 2014