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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00908752




Registration number
NCT00908752
Ethics application status
Date submitted
22/05/2009
Date registered
27/05/2009
Date last updated
2/12/2019

Titles & IDs
Public title
Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
Scientific 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)
Secondary ID [1] 0 0
EUDRACT # 2008-008715-26
Secondary ID [2] 0 0
CA182-037
Universal Trial Number (UTN)
Trial acronym
BRISK TA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brivanib
Other interventions - Brivanib Placebo
Treatment: Surgery - TACE Therapy

Active comparator: Brivanib - Adjuvant treatment with TACE Therapy

Placebo comparator: Brivanib Placebo - Placebo adjuvant treatment with TACE Therapy


Treatment: Drugs: Brivanib
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

Other interventions: Brivanib Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

Treatment: Surgery: TACE Therapy
Trans-Arterial Chemo-Embolization Therapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Survival will be assessed continuously
Secondary outcome [1] 0 0
To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
Timepoint [1] 0 0
Every 8 weeks
Secondary outcome [2] 0 0
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
Timepoint [2] 0 0
Every 8 weeks
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
End of Study
Secondary outcome [4] 0 0
To evaluate the safety of brivanib in combination with TACE
Timepoint [4] 0 0
Every 8 weeks

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/01/2018
Sample size
Target
Accrual to date
Final
734
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Rhode Island
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Guangdong
Country [12] 0 0
China
State/province [12] 0 0
Guangxi
Country [13] 0 0
China
State/province [13] 0 0
Heilongjiang
Country [14] 0 0
China
State/province [14] 0 0
Hunan
Country [15] 0 0
China
State/province [15] 0 0
Jiangsu
Country [16] 0 0
China
State/province [16] 0 0
Jilin
Country [17] 0 0
China
State/province [17] 0 0
Shan3xi
Country [18] 0 0
China
State/province [18] 0 0
Shanghai
Country [19] 0 0
China
State/province [19] 0 0
Sichuan
Country [20] 0 0
China
State/province [20] 0 0
Tianjin
Country [21] 0 0
China
State/province [21] 0 0
Zhejiang
Country [22] 0 0
France
State/province [22] 0 0
Angers
Country [23] 0 0
France
State/province [23] 0 0
Bondy
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux
Country [25] 0 0
France
State/province [25] 0 0
Clichy Cedex
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France
State/province [26] 0 0
Creteil Cedex
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France
State/province [27] 0 0
Grenoble
Country [28] 0 0
France
State/province [28] 0 0
Lille Cedex
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France
State/province [29] 0 0
Lyon Cedex 04
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France
State/province [30] 0 0
Marseille Cedex 05
Country [31] 0 0
France
State/province [31] 0 0
Paris Cedex
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
France
State/province [33] 0 0
Toulouse Cedex 09
Country [34] 0 0
Hong Kong
State/province [34] 0 0
Hong Kong
Country [35] 0 0
Hong Kong
State/province [35] 0 0
New Territories
Country [36] 0 0
Italy
State/province [36] 0 0
Genova
Country [37] 0 0
Italy
State/province [37] 0 0
Padova
Country [38] 0 0
Italy
State/province [38] 0 0
Pisa
Country [39] 0 0
Italy
State/province [39] 0 0
Roma
Country [40] 0 0
Japan
State/province [40] 0 0
Aichi
Country [41] 0 0
Japan
State/province [41] 0 0
Chiba
Country [42] 0 0
Japan
State/province [42] 0 0
Gifu
Country [43] 0 0
Japan
State/province [43] 0 0
Hiroshima
Country [44] 0 0
Japan
State/province [44] 0 0
Hokkaido
Country [45] 0 0
Japan
State/province [45] 0 0
Ishikawa
Country [46] 0 0
Japan
State/province [46] 0 0
Kanagawa
Country [47] 0 0
Japan
State/province [47] 0 0
Kochi
Country [48] 0 0
Japan
State/province [48] 0 0
Kumamoto
Country [49] 0 0
Japan
State/province [49] 0 0
Kyoto
Country [50] 0 0
Japan
State/province [50] 0 0
MIE
Country [51] 0 0
Japan
State/province [51] 0 0
Okayama
Country [52] 0 0
Japan
State/province [52] 0 0
Osaka
Country [53] 0 0
Japan
State/province [53] 0 0
Shizuoka
Country [54] 0 0
Japan
State/province [54] 0 0
Tokyo
Country [55] 0 0
Japan
State/province [55] 0 0
Toyama
Country [56] 0 0
Japan
State/province [56] 0 0
Nishinomiya-shi
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Busan
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Kyunggi-do
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Suwon
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Taegu
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
Taiwan
State/province [64] 0 0
Kaohsiung
Country [65] 0 0
Taiwan
State/province [65] 0 0
Taichung
Country [66] 0 0
Taiwan
State/province [66] 0 0
Tainan
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taipei
Country [68] 0 0
Taiwan
State/province [68] 0 0
Taoyuan
Country [69] 0 0
Thailand
State/province [69] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00908752
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00908752