Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC

Hepatocellular Carcinoma Clinical Trial

— BRISK TA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908752
• Other study ID #: CA182-037
• Secondary ID: EUDRACT # 2008-0
• Status: Completed
• Phase: Phase 3
• Start date: July 20, 2009
• Est. completion date: January 26, 2018

Study information

• Verified date: November 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 734
• Est. completion date: January 26, 2018
• Est. primary completion date: September 28, 2012
• 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:

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Brivanib
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

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

Procedure:
• TACE Therapy
Trans-Arterial Chemo-Embolization Therapy

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Australia	Local Institution	Parkville	Victoria
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Vancouver	British Columbia
China	Local Institution	Beijing	Beijing
China	Local Institution	Changchun	Jilin
China	Local Institution	Changsha	Hunan
China	Local Institution	Changzhou	Jiangsu
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Guanzhou	Guangdong
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Harbin	Heilongjiang
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanning	Guangxi
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Suzhou	Jiangsu
China	Local Institution	Tianjing	Tianjin
China	Local Institution	Xi'an	Shan3xi
France	Local Institution	Angers
France	Local Institution	Bondy
France	Local Institution	Bordeaux
France	Local Institution	Clichy Cedex
France	Local Institution	Creteil Cedex
France	Local Institution	Grenoble
France	Local Institution	Lille Cedex
France	Local Institution	Lyon Cedex 04
France	Local Institution	Marseille Cedex 05
France	Local Institution	Paris
France	Local Institution	Paris Cedex
France	Local Institution	Toulouse Cedex 09
Hong Kong	Local Institution	Hong Kong
Hong Kong	Local Institution	New Territories
Italy	Local Institution	Genova
Italy	Local Institution	Padova
Italy	Local Institution	Pisa
Italy	Local Institution	Roma
Japan	Local Institution	Chiba-shi	Chiba
Japan	Local Institution	Chuo-ku	Tokyo
Japan	Local Institution	Higashinari-ku	Osaka
Japan	Local Institution	Hiroshima City	Hiroshima
Japan	Local Institution	Kanazawa-shi	Ishikawa
Japan	Local Institution	Kashiwa-shi	Chiba
Japan	Local Institution	Kawasaki-shi	Kanagawa
Japan	Local Institution	Kochi-shi	Kochi
Japan	Local Institution	Kumamoto-shi	Kumamoto
Japan	Local Institution	Kure-shi	Hiroshima
Japan	Local Institution	Kyoto-shi	Kyoto
Japan	Local Institution	Minato-ku	Tokyo
Japan	Local Institution	Musashino-shi	Tokyo
Japan	Local Institution	Nishinomiya-shi
Japan	Local Institution	Ogaki-shi	Gifu
Japan	Local Institution	Okayama-shi	Okayama
Japan	Local Institution	Osaka-sayama City	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sunto-gun	Shizuoka
Japan	Local Institution	Toyama City	Toyama
Japan	Local Institution	Toyoake City	Aichi
Japan	Local Institution	Tsu-shi	MIE
Japan	Local Institution	Yokohama	Kanagawa
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Kyunggi-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
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Suwon
Korea, Republic of	Local Institution	Taegu
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Valencia
Spain	Local Institution	Valencia
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan
Thailand	Local Institution	Bangkok
Thailand	Local Institution	Bangkok
United States	Montefiore Medical Center	Bronx	New York
United States	University Of Virginia Health System	Charlottesville	Virginia
United States	The University Of Texas MD Anderson Cancer Center	Houston	Texas
United States	Richard Finn, M.D.	Los Angeles	California
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  China,  France,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Survival will be assessed continuously
Secondary	To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy		Every 8 weeks
Secondary	To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms		Every 8 weeks
Secondary	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		End of Study
Secondary	To evaluate the safety of brivanib in combination with TACE		Every 8 weeks

External Links

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