Clinical trial NCT00908752: Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
Official title: A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 734
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 (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.


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

Inclusion Criteria:

* Patients with diagnosis of hepatocellular carcinoma
* Cirrhotic status of Child-Pugh Class A or B with a score of 7
* ECOG performance status of 0 or 1
* Adequate hematologic, hepatic, and renal function

Exclusion criteria:

* Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
* History of cardiac disease
* Active and untreated hepatitis B
* Inability to swallow tablets or untreated malabsorption syndrome
* History of human immunodeficiency virus (HIV) infection

Primary outcomes:
measure: To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
timeFrame: Survival will be assessed continuously
Secondary outcomes:
measure: To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
timeFrame: Every 8 weeks
measure: To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
timeFrame: Every 8 weeks
measure: To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms
timeFrame: End of Study
measure: To evaluate the safety of brivanib in combination with TACE
timeFrame: Every 8 weeks
Other outcomes:
Locations:
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: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: The University Of Texas MD Anderson Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Guanzhou
country: China
facility: Local Institution
state: Guangdong
city: Nanning
country: China
facility: Local Institution
state: Guangxi
city: Harbin
country: China
facility: Local Institution
state: Heilongjiang
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: Changchun
country: China
facility: Local Institution
state: Jilin
city: Xi'an
country: China
facility: Local Institution
state: Shan3xi
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Tianjing
country: China
facility: Local Institution
state: Tianjin
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Angers
country: France
facility: Local Institution
city: Bondy
country: France
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
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Lyon Cedex 04
country: France
facility: Local Institution
city: Marseille Cedex 05
country: France
facility: Local Institution
city: Paris Cedex
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Toulouse Cedex 09
country: France
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: New Territories
country: Hong Kong
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Toyoake City
country: Japan
facility: Local Institution
state: Aichi
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: Hiroshima City
country: Japan
facility: Local Institution
state: Hiroshima
city: Kure-shi
country: Japan
facility: Local Institution
state: Hiroshima
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: Kochi-shi
country: Japan
facility: Local Institution
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Local Institution
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Local Institution
state: Kyoto
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: Toyama City
country: Japan
facility: Local Institution
state: Toyama
city: Nishinomiya-shi
country: Japan
facility: Local Institution
city: Busan
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: Suwon
country: Korea, Republic of
facility: Local Institution
city: Taegu
country: Korea, Republic of
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Kaohsiung
country: Taiwan
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
country: Taiwan
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: