Clinical trial NCT00858871: First Line Hepato Cellular Carcinoma (HCC)
Official title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepato Cellular Carcinoma (HCC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 1714
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Inclusion Criteria:

* 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

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

Primary outcomes:
measure: To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
timeFrame: Survival will be assessed continuously
Secondary outcomes:
measure: To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC
timeFrame: Every 6 weeks
measure: To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC
timeFrame: Every 6 weeks
measure: To determine duration of response, duration of disease control, and time to response (TTR)
timeFrame: Every 6 weeks
measure: To assess the safety profile of brivanib and sorafenib
timeFrame: Every 6 weeks
measure: To explore PK and exposure-response in the study population
timeFrame: Every 6 weeks
measure: To compare time to symptomatic progression
timeFrame: Every 6 weeks
measure: To compare health-related quality of life
timeFrame: Every 6 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Little Rock
country: United States
facility: Univ Of Ark For Med Sci
state: Arkansas
city: Downey
country: United States
facility: Agajanian Institute Of Hematology And Oncology
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: West Haven
country: United States
facility: Va Ct Healthcare System
state: Connecticut
city: Lake Worth
country: United States
facility: Medical Specialists Of Palm Beaches
state: Florida
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Ann Arbor
country: United States
facility: 3912 Taubman Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Philadelphia
country: United States
facility: Thomas Jefferson Univ.
state: Pennsylvania
city: Richmond
country: United States
facility: Mcguire Dvamc
state: Virginia
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
city: Caba
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Concord
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead Nsw
country: Australia
facility: Local Institution
state: New South Wales
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Prahan
country: Australia
facility: Local Institution
state: Victoria
city: Liege
country: Belgium
facility: Local Institution
city: Salvador - Ba
country: Brazil
facility: Local Institution
state: Bahia
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Goiania
country: Brazil
facility: Local Institution
state: Goias
city: Divinopolis
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Jau
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Chongqing
country: China
facility: Local Institution
state: Chongqing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guanzhou
country: China
facility: Local Institution
state: Guangdong
city: Nanning
country: China
facility: Local Institution
state: Guangxi
city: Wuhan
country: China
facility: Local Institution
state: Hubei
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Changzhou
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Suzhou
country: China
facility: Local Institution
state: Jiangsu
city: Dalian
country: China
facility: Local Institution
state: Liaoning
city: Xi An
country: China
facility: Local Institution
state: Shaanxi
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Brno
country: Czech Republic
facility: Local Institution
city: Prague 5
country: Czech Republic
facility: Local Institution
city: Praha 2
country: Czech Republic
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Clichy Cedex
country: France
facility: Local Institution
city: Creteil Cedex
country: France
facility: Local Institution
city: Grenoble Cedex 09
country: France
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Lyon Cedex 04
country: France
facility: Local Institution
city: Marseille Cedex 05
country: France
facility: Local Institution
city: Marseille Cedex 9
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Vandoeuvre Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Halle
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Shatin
country: Hong Kong
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Kochi
country: India
facility: Local Institution
state: Kerala
city: Trivandrum
country: India
facility: Local Institution
state: Kerala
city: Pune
country: India
facility: Local Institution
state: Maharashtra
city: Ahmedabad
country: India
facility: Local Institution
city: Chennai
country: India
facility: Local Institution
city: Coimbatore
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Kolkata
country: India
facility: Local Institution
city: Kolkata
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torrette -Ancona
country: Italy
facility: Local Institution
city: Kashiwa-shi
country: Japan
facility: Local Institution
state: Chiba
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kanazawa-Shi
country: Japan
facility: Local Institution
state: Ishikawa
city: Kawasaki-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Yokohama
country: Japan
facility: Local Institution
state: Kanagawa
city: Tsu-shi
country: Japan
facility: Local Institution
state: MIE
city: Okayama-shi
country: Japan
facility: Local Institution
state: Okayama
city: Higashinari-ku
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-Sayama City
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Sunto-gun
country: Japan
facility: Local Institution
state: Shizuoka
city: Chuo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Musashino-shi
country: Japan
facility: Local Institution
state: Tokyo
city: Shimonoseki-shi
country: Japan
facility: Local Institution
state: Yamaguchi
city: Nishinomiya-shi
country: Japan
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Kyunggi-do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: D.f.
country: Mexico
facility: Local Institution
state: Distrito Federal
city: D.f.
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Tlalpan
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Distrito Federal
country: Mexico
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Gliwice
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Observatory, Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Rondebosch
country: South Africa
facility: Local Institution
state: Western Cape
city: Santiago De Compostela
country: Spain
facility: Local Institution
state: A Coruna
city: Alicante
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Changhua
country: Taiwan
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Tainan R.O.C.
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan
country: Taiwan
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Ankara
country: Turkey
facility: Local Institution
city: Antalya
country: Turkey
facility: Local Institution
city: Istanbul
country: Turkey
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
city: Kayseri
country: Turkey
facility: Local Institution
city: Bristol
country: United Kingdom
facility: Local Institution
state: Avon
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
city: Leeds
country: United Kingdom
facility: Local Institution
state: Yorkshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.