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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)
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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
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Secondary ID [1]
0
0
EUDRACT # 2008-003533-24
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Secondary ID [2]
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0
CA182-033
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Universal Trial Number (UTN)
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Trial acronym
BRISK FL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepato Cellular Carcinoma (HCC)
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Cancer
0
0
0
0
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Liver
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
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Assessment method [1]
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0
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Timepoint [1]
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0
Survival will be assessed continuously
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Secondary outcome [1]
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0
To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC
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Assessment method [1]
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0
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Timepoint [1]
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0
Every 6 weeks
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Secondary outcome [2]
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0
To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC
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Assessment method [2]
0
0
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Timepoint [2]
0
0
Every 6 weeks
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Secondary outcome [3]
0
0
To determine duration of response, duration of disease control, and time to response (TTR)
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Assessment method [3]
0
0
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Timepoint [3]
0
0
Every 6 weeks
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Secondary outcome [4]
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0
To assess the safety profile of brivanib and sorafenib
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Assessment method [4]
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0
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Timepoint [4]
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0
Every 6 weeks
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Secondary outcome [5]
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0
To explore PK and exposure-response in the study population
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Assessment method [5]
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0
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Timepoint [5]
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Every 6 weeks
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Secondary outcome [6]
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To compare time to symptomatic progression
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Assessment method [6]
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0
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Timepoint [6]
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Every 6 weeks
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Secondary outcome [7]
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0
To compare health-related quality of life
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Assessment method [7]
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0
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Timepoint [7]
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Every 6 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2013
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Sample size
Target
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Accrual to date
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Final
1714
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Local Institution - Camperdown
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Local Institution - Concord
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Local Institution - Westmead Nsw
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Recruitment hospital [4]
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Local Institution - Parkville
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Recruitment hospital [5]
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Local Institution - Prahan
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2145 - Westmead Nsw
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Recruitment postcode(s) [4]
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3050 - Parkville
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Recruitment postcode(s) [5]
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3004 - Prahan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00858871
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Trial related presentations / publications
Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27. Johnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA, Hsu CH, Hu TH, Heo J, Xu J, Lu L, Chao Y, Boucher E, Han KH, Paik SW, Robles-Avina J, Kudo M, Yan L, Sobhonslidsuk A, Komov D, Decaens T, Tak WY, Jeng LB, Liu D, Ezzeddine R, Walters I, Cheng AL. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol. 2013 Oct 1;31(28):3517-24. doi: 10.1200/JCO.2012.48.4410. Epub 2013 Aug 26.
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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https://clinicaltrials.gov/study/NCT00858871
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