ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00908752
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Brivanib Other: Brivanib Placebo Procedure: TACE Therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 734 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Actual Study Start Date : July 20, 2009
Actual Primary Completion Date : September 28, 2012
Actual Study Completion Date : January 26, 2018

Arm Intervention/treatment
Active Comparator: Brivanib
Adjuvant treatment with TACE Therapy
Drug: Brivanib
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664
Procedure: TACE Therapy
Trans-Arterial Chemo-Embolization Therapy
Placebo Comparator: Brivanib Placebo
Placebo adjuvant treatment with TACE Therapy
Other: Brivanib Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Procedure: TACE Therapy
Trans-Arterial Chemo-Embolization Therapy



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908752


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00908752     History of Changes
Other Study ID Numbers: CA182-037
EUDRACT # 2008-008715-26
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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