Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment

Liver Cancer Clinical Trial

— BRISK PS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825955
• Other study ID #: CA182-034
• Secondary ID: EUDRACT #: 2008-
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2009
• Est. completion date: August 25, 2017

Study information

• Verified date: September 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: August 25, 2017
• Est. primary completion date: November 15, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity

Other:
• Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

Procedure:
• Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy

Locations

Country	Name	City	State
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Rosario	Santa FE
Belgium	Local Institution	Bruxelles
Brazil	Local Institution	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Salvador - Ba	Bahia
Brazil	Local Institution	Sao Paulo
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
China	Local Institution	Beijing	Beijing
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guanzhou	Guangdong
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanning	Guangxi
China	Local Institution	Tianjing	Tianjin
China	Local Institution	Wuhan	Hubei
France	Local Institution	Bordeaux
France	Local Institution	Creteil Cedex
France	Local Institution	Grenoble Cedex 09
France	Local Institution	Lille Cedex
France	Local Institution	Lyon Cedex 04
France	Local Institution	Montpellier Cedex
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Paris Cedex
France	Local Institution	Rennes
France	Local Institution	Toulouse Cedex 09
France	Local Institution	Vandoeuvre Cedex
France	Local Institution	Villejuif
Germany	Local Institution	Berlin
Germany	Local Institution	Frankfurt
Germany	Local Institution	Freiburg
Germany	Local Institution	Halle
Germany	Local Institution	Hannover
Germany	Local Institution	Mainz
Germany	Local Institution	Ulm
Germany	Local Institution	Wuerzburg
Greece	Local Institution	Kifisia
Greece	Local Institution	Thessaloniki
Hong Kong	Local Institution	Hong Kong
India	Local Institution	Chennai
India	Local Institution	Kochi	Kerala
India	Local Institution	Kolkata
India	Local Institution	New Delhi
Italy	Local Institution	Ancona
Italy	Local Institution	Meldola (fc)
Italy	Local Institution	Milano
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Italy	Local Institution	Pisa
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Chiba-shi	Chiba
Japan	Local Institution	Chuo-ku	Tokyo
Japan	Local Institution	Higashinari-ku	Osaka
Japan	Local Institution	Kashiwa-shi	Chiba
Japan	Local Institution	Kochi-shi	Kochi
Japan	Local Institution	Kyoto-shi	Kyoto
Japan	Local Institution	Musashino-shi	Tokyo
Japan	Local Institution	Nishinomiya-shi
Japan	Local Institution	Ogaki-shi	Gifu
Japan	Local Institution	Osaka-sayama-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Shimonoseki-shi	Yamaguchi
Japan	Local Institution	Sunto-gun	Shizuoka
Japan	Local Institution	Toyama City	Toyama
Japan	Local Institution	Tsu-shi	MIE
Japan	Local Institution	Yokohama	Kanagawa
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Cuernavaca	Morelos
Mexico	Local Institution	D.f.	Distrito Federal
Mexico	Local Institution	Toluca	Estado DE Mexico
Puerto Rico	Local Institution	San Juan
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Oviedo
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan Hsien
United States	3912 Taubman Center	Ann Arbor	Michigan
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Health System Irb	Detroit	Michigan
United States	UF Health Clinical Research Center	Gainesville	Florida
United States	University Of Texas	Houston	Texas
United States	Univ Of Ark For Med Sci	Little Rock	Arkansas
United States	Loma Linda University Cancer Center	Loma Linda	California
United States	Richard Finn, M.D.	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai School Of Medicine	New York	New York
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Sci Univ	Portland	Oregon
United States	Mcguire Dvamc	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	The University Of Texas Health Science Center	San Antonio	Texas
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Pacific Hematology Oncology Associates	San Francisco	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  China,  France,  Germany,  Greece,  Hong Kong,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Puerto Rico,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death
Secondary	To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)		35 months
Secondary	To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria		35 months
Secondary	To assess duration of response, duration of disease control and time to response		6 weeks
Secondary	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		35 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form