Clinical trial NCT00825955: Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
Official title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-01-21
Enrollment: 587
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 determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib


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 disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy
* Patient has failed ≥ 14 days of Sorafenib treatment
* Cirrhotic status of Child-Pugh Class A or B with a score of 7
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
* Subjects who have a life expectancy of at least 8 weeks
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy
* Previous or concurrent cancer that is distinct in primary site
* History of active cardiac disease
* Thrombotic or embolic events within the past 6 months
* Any other hemorrhage/bleeding event \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks
* Inability to swallow tablets or untreated malabsorption syndrome
* History of human immunodeficiency virus (HIV) infection
* Prior use of systemic investigational agents for HCC (except for Sorafenib)

Primary outcomes:
measure: To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC
timeFrame: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death
Secondary outcomes:
measure: To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)
timeFrame: 35 months
measure: To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria
timeFrame: 35 months
measure: To assess duration of response, duration of disease control and time to response
timeFrame: 6 weeks
measure: To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review
timeFrame: 35 months
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: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Los Angeles
country: United States
facility: Richard Finn, M.D.
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Gainesville
country: United States
facility: UF Health Clinical Research Center
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: Henry Ford Health System Irb
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Mount Sinai School Of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Sci Univ
state: Oregon
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: University Of Texas
state: Texas
city: San Antonio
country: United States
facility: The University Of Texas Health Science Center
state: Texas
city: Richmond
country: United States
facility: Mcguire Dvamc
state: Virginia
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa FE
city: Bruxelles
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: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
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: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Beijing
country: China
facility: Local Institution
state: Beijing
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: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Tianjing
country: China
facility: Local Institution
state: Tianjin
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Bordeaux
country: France
facility: Local Institution
city: Creteil Cedex
country: France
facility: Local Institution
city: Grenoble Cedex 09
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Lyon Cedex 04
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Montpellier Cedex
country: France
facility: Local Institution
city: Paris Cedex
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: Toulouse Cedex 09
country: France
facility: Local Institution
city: Vandoeuvre Cedex
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Freiburg
country: Germany
facility: Local Institution
city: Halle
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Wuerzburg
country: Germany
facility: Local Institution
city: Kifisia
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Kochi
country: India
facility: Local Institution
state: Kerala
city: Chennai
country: India
facility: Local Institution
city: Kolkata
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: Ancona
country: Italy
facility: Local Institution
city: Meldola (fc)
country: Italy
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: Padova
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Chiba-shi
country: Japan
facility: Local Institution
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Local Institution
state: Chiba
city: Ogaki-shi
country: Japan
facility: Local Institution
state: Gifu
city: Yokohama
country: Japan
facility: Local Institution
state: Kanagawa
city: Kochi-shi
country: Japan
facility: Local Institution
state: Kochi
city: Kyoto-shi
country: Japan
facility: Local Institution
state: Kyoto
city: Tsu-shi
country: Japan
facility: Local Institution
state: MIE
city: Higashinari-ku
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-sayama-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: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Musashino-shi
country: Japan
facility: Local Institution
state: Tokyo
city: Toyama City
country: Japan
facility: Local Institution
state: Toyama
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: 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: Toluca
country: Mexico
facility: Local Institution
state: Estado DE Mexico
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
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: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Oviedo
country: Spain
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Tainan
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan Hsien
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Lencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Rios J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM. Objective response by mRECIST as a predictor and potential surrogate end-point of overall survival in advanced HCC. J Hepatol. 2017 Jun;66(6):1166-1172. doi: 10.1016/j.jhep.2017.01.012. Epub 2017 Jan 26.
citation: Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol. 2013 Oct 1;31(28):3509-16. doi: 10.1200/JCO.2012.47.3009. Epub 2013 Aug 26.