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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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United States of America
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Arizona
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Arkansas
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California
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Wisconsin
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Buenos Aires
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Santa Fe
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Belgium
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Liege
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Bahia
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Ceara
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Goias
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Parana
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Rio Grande Do Sul
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Sao Paulo
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Brno
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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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Clichy Cedex
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Grenoble Cedex 09
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Shatin
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Kerala
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Roma
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Chiba
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MIE
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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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Gyeonggi-do
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Korea, Republic of
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Kyunggi-do
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Moscow
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Gauteng
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Kwa Zulu Natal
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Western Cape
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Kayseri
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Greater London
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Greater Manchester
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West Midlands
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United Kingdom
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Yorkshire

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 of brivanib versus sorafenib in
subjects with advanced HCC who have not received prior systemic therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00858871
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/ct2/show/NCT00858871