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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivanib
Brivanib Placebo
TACE Therapy
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Richard Finn, M.D.
  • Sharp Clinical Oncology Research
  • Montefiore Medical Center
  • Rhode Island Hospital
  • The University Of Texas MD Anderson Cancer Center
  • University Of Virginia Health System
  • Seattle Cancer Care Alliance
  • Local Institution
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Brivanib

Brivanib Placebo

Arm Description

Adjuvant treatment with TACE Therapy

Placebo adjuvant treatment with TACE Therapy

Outcomes

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

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
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
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
To evaluate the safety of brivanib in combination with TACE

Full Information

First Posted
May 22, 2009
Last Updated
November 26, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00908752
Brief Title
Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
Acronym
BRISK TA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2009 (Actual)
Primary Completion Date
September 28, 2012 (Actual)
Study Completion Date
January 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
734 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivanib
Arm Type
Active Comparator
Arm Description
Adjuvant treatment with TACE Therapy
Arm Title
Brivanib Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo adjuvant treatment with TACE Therapy
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Intervention Type
Other
Intervention Name(s)
Brivanib Placebo
Intervention Description
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Intervention Type
Procedure
Intervention Name(s)
TACE Therapy
Intervention Description
Trans-Arterial Chemo-Embolization Therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
Time Frame
Every 8 weeks
Title
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
Title
To evaluate the safety of brivanib in combination with TACE
Time Frame
Every 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Richard Finn, M.D.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2401
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The University Of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1405BCK
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
610080
Country
China
Facility Name
Local Institution
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Local Institution
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Local Institution
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Local Institution
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Local Institution
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shan3xi
ZIP/Postal Code
710032
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Local Institution
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution
City
Tianjing
State/Province
Tianjin
ZIP/Postal Code
30060
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Local Institution
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Local Institution
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Local Institution
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Paris Cedex
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Local Institution
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Hong Kong
ZIP/Postal Code
8525
Country
Hong Kong
Facility Name
Local Institution
City
New Territories
ZIP/Postal Code
8520
Country
Hong Kong
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution
City
Toyoake City
State/Province
Aichi
ZIP/Postal Code
470-1101
Country
Japan
Facility Name
Local Institution
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Local Institution
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0882
Country
Japan
Facility Name
Local Institution
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
5038502
Country
Japan
Facility Name
Local Institution
City
Hiroshima City
State/Province
Hiroshima
ZIP/Postal Code
734-0037
Country
Japan
Facility Name
Local Institution
City
Kure-shi
State/Province
Hiroshima
ZIP/Postal Code
7370023
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Local Institution
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Local Institution
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Local Institution
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
7818555
Country
Japan
Facility Name
Local Institution
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Facility Name
Local Institution
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6028566
Country
Japan
Facility Name
Local Institution
City
Tsu-shi
State/Province
MIE
ZIP/Postal Code
5148507
Country
Japan
Facility Name
Local Institution
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-0082
Country
Japan
Facility Name
Local Institution
City
Higashinari-ku
State/Province
Osaka
ZIP/Postal Code
5378511
Country
Japan
Facility Name
Local Institution
City
Osaka-sayama City
State/Province
Osaka
ZIP/Postal Code
5890014
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5438555
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Local Institution
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Local Institution
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-0001
Country
Japan
Facility Name
Local Institution
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
180-0023
Country
Japan
Facility Name
Local Institution
City
Toyama City
State/Province
Toyama
ZIP/Postal Code
9308550
Country
Japan
Facility Name
Local Institution
City
Nishinomiya-shi
ZIP/Postal Code
6638501
Country
Japan
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
609735
Country
Korea, Republic of
Facility Name
Local Institution
City
Kyunggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Taegu
ZIP/Postal Code
700721
Country
Korea, Republic of
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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