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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00858871




Registration number
NCT00858871
Ethics application status
Date submitted
9/03/2009
Date registered
10/03/2009
Date last updated
17/10/2016

Titles & IDs
Public title
First Line Hepato Cellular Carcinoma (HCC)
Scientific title
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Secondary ID [1] 0 0
EUDRACT # 2008-003533-24
Secondary ID [2] 0 0
CA182-033
Universal Trial Number (UTN)
Trial acronym
BRISK FL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepato Cellular Carcinoma (HCC) 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
Treatment: Drugs - Placebo
Treatment: Drugs - Sorafenib
Treatment: Drugs - Placebo

Active comparator: Brivanib -

Active comparator: Sorafenib -


Treatment: Drugs: Brivanib
Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity

Treatment: Drugs: Placebo
Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity

Treatment: Drugs: Sorafenib
Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity

Treatment: Drugs: Placebo
Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
Timepoint [1] 0 0
Survival will be assessed continuously
Secondary outcome [1] 0 0
To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC
Timepoint [1] 0 0
Every 6 weeks
Secondary outcome [2] 0 0
To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC
Timepoint [2] 0 0
Every 6 weeks
Secondary outcome [3] 0 0
To determine duration of response, duration of disease control, and time to response (TTR)
Timepoint [3] 0 0
Every 6 weeks
Secondary outcome [4] 0 0
To assess the safety profile of brivanib and sorafenib
Timepoint [4] 0 0
Every 6 weeks
Secondary outcome [5] 0 0
To explore PK and exposure-response in the study population
Timepoint [5] 0 0
Every 6 weeks
Secondary outcome [6] 0 0
To compare time to symptomatic progression
Timepoint [6] 0 0
Every 6 weeks
Secondary outcome [7] 0 0
To compare health-related quality of life
Timepoint [7] 0 0
Every 6 weeks

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



* Histologic or cytologic confirmed diagnosis of HCC.
* Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
* Child-Pugh Class A
* ECOG performance status 0-1
* 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
* Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
* History of active cardiac disease
* Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
* Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
* Inability to swallow tablets or untreated malabsorption syndrome

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
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
1714
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Westmead Nsw
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment hospital [5] 0 0
Local Institution - Prahan
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2145 - Westmead Nsw
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
3004 - Prahan
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Kentucky
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Michigan
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Pennsylvania
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United States of America
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Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Belgium
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Liege
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Brazil
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Bahia
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Brazil
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Ceara
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Brazil
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Goias
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Brazil
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Minas Gerais
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Brazil
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Parana
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Brazil
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Rio Grande do Sul
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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Chongqing
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Guangdong
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China
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Guangxi
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Liaoning
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China
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Shaanxi
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Shanghai
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China
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Sichuan
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China
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Zhejiang
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Czech Republic
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Brno
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Czech Republic
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Prague 5
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Czech Republic
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Praha 2
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France
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Bordeaux
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France
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Clichy Cedex
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France
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Creteil Cedex
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France
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Grenoble Cedex 09
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France
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Lille
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Lyon Cedex 04
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France
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Marseille Cedex 05
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France
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Marseille Cedex 9
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France
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Paris
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France
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Rennes
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France
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Vandoeuvre Cedex
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Germany
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Berlin
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Magdeburg
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Germany
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Ulm
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Hong Kong
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Shatin
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Kerala
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Maharashtra
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Ahmedabad
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Chennai
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Coimbatore
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Milano
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Napoli
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Italy
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Pisa
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Italy
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Roma
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Torrette -Ancona
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Chiba
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Ishikawa
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Kanagawa
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MIE
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Okayama
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Osaka
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Shizuoka
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Tokyo
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Yamaguchi
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Nishinomiya-shi
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Korea, Republic of
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Busan
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Daegu
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Kyunggi-do
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Nuevo Leon
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Aguascalientes
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Gdansk
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Gliwice
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Krakow
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Puerto Rico
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San Juan
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Russian Federation
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Moscow
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South Africa
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Gauteng
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South Africa
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Kwa Zulu Natal
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South Africa
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Western Cape
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Spain
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A Coruna
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Alicante
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Barcelona
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Sweden
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Stockholm
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Sweden
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Uppsala
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Changhua
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Kaohsiung
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Thailand
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Ankara
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Antalya
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Istanbul
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Izmir
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Kayseri
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United Kingdom
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Avon
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Greater London
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Greater Manchester
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United Kingdom
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West Midlands
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United Kingdom
State/province [123] 0 0
Yorkshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00858871