First Line Hepato Cellular Carcinoma (HCC)

Hepato Cellular Carcinoma (HCC) Clinical Trial

— BRISK FL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858871
• Other study ID #: CA182-033
• Secondary ID: EUDRACT # 2008-0
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2009
• Last updated: October 14, 2016
• Start date: May 2009
• Est. completion date: September 2013

Study information

• Verified date: October 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Agence Fédérale des Médicaments et des Produits de SantéBrazil: National Health Surveillance AgencyCanada: Health CanadaChina: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Bundeinstitut fur Arzneimittel und Medizinprodukte (BfArM)India: Central Drugs Standard Control OrganizationHong Kong: Department of HealthItaly: Istituto Superiore de Sanita (ISS)Japan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationMexico: Federal Commission for Sanitary Risks ProtectionPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSweden: LakemedelverketTaiwan: Department of HealthThailand: Food and Drug AdministrationTurkey: T.C. Saglik Bakanligi Ilac Eczacilik Genel MudurluguUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1714
• Est. completion date: September 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepato Cellular Carcinoma (HCC)

Intervention

Drug:
• Brivanib
Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
• Placebo
Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity
• Sorafenib
Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity
• Placebo
Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Caba	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Rosario	Santa Fe
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Concord	New South Wales
Australia	Local Institution	Parkville	Victoria
Australia	Local Institution	Prahan	Victoria
Australia	Local Institution	Westmead Nsw	New South Wales
Belgium	Local Institution	Liege
Brazil	Local Institution	Barretos	Sao Paulo
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Divinopolis	Minas Gerais
Brazil	Local Institution	Fortaleza	Ceara
Brazil	Local Institution	Goiania	Goias
Brazil	Local Institution	Jau	Sao Paulo
Brazil	Local Institution	Porto Alegre	Rio Grande do Sul
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
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	London	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Vancouver	British Columbia
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Changsha	Hunan
China	Local Institution	Changzhou	Jiangsu
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Chongqing	Chongqing
China	Local Institution	Dalian	Liaoning
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guanzhou	Guangdong
China	Local Institution	Hangzhou	Zhejiang
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	Suzhou	Jiangsu
China	Local Institution	Wuhan	Hubei
China	Local Institution	Xi An	Shaanxi
Czech Republic	Local Institution	Brno
Czech Republic	Local Institution	Prague 5
Czech Republic	Local Institution	Praha 2
France	Local Institution	Bordeaux
France	Local Institution	Clichy Cedex
France	Local Institution	Creteil Cedex
France	Local Institution	Grenoble Cedex 09
France	Local Institution	Lille
France	Local Institution	Lyon Cedex 04
France	Local Institution	Marseille Cedex 05
France	Local Institution	Marseille Cedex 9
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Rennes
France	Local Institution	Vandoeuvre Cedex
Germany	Local Institution	Berlin
Germany	Local Institution	Halle
Germany	Local Institution	Hamburg
Germany	Local Institution	Magdeburg
Germany	Local Institution	Ulm
Hong Kong	Local Institution	Hong Kong
Hong Kong	Local Institution	Shatin
India	Local Institution	Ahmedabad
India	Local Institution	Chennai
India	Local Institution	Coimbatore
India	Local Institution	Hyderabad
India	Local Institution	Hyderabad	Andhra Pradesh
India	Local Institution	Kochi	Kerala
India	Local Institution	Kolkata
India	Local Institution	Kolkata
India	Local Institution	Mumbai
India	Local Institution	Mumbai
India	Local Institution	New Delhi
India	Local Institution	Pune	Maharashtra
India	Local Institution	Trivandrum	Kerala
Italy	Local Institution	Milano
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Pisa
Italy	Local Institution	Roma
Italy	Local Institution	Torrette -Ancona
Japan	Local Institution	Chuo-Ku	Tokyo
Japan	Local Institution	Higashinari-ku	Osaka
Japan	Local Institution	Kanazawa-Shi	Ishikawa
Japan	Local Institution	Kashiwa-shi	Chiba
Japan	Local Institution	Kawasaki-shi	Kanagawa
Japan	Local Institution	Minato-ku	Tokyo
Japan	Local Institution	Musashino-shi	Tokyo
Japan	Local Institution	Nishinomiya-shi
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	Shimonoseki-shi	Yamaguchi
Japan	Local Institution	Sunto-gun	Shizuoka
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	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
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	D.f.	Distrito Federal
Mexico	Local Institution	D.f.	Distrito Federal
Mexico	Local Institution	Distrito Federal
Mexico	Local Institution	Mexico City	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Tlalpan	Distrito Federal
Poland	Local Institution	Gdansk
Poland	Local Institution	Gliwice
Poland	Local Institution	Krakow
Poland	Local Institution	Warszawa
Puerto Rico	Local Institution	San Juan
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Durban	Kwa Zulu Natal
South Africa	Local Institution	Observatory, Cape Town	Western Cape
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Rondebosch	Western Cape
Spain	Local Institution	Alicante
Spain	Local Institution	Barcelona
Spain	Local Institution	Santiago De Compostela	A Coruna
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Uppsala
Taiwan	Local Institution	Changhua
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan R.O.C.
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan
Thailand	Local Institution	Bangkok
Thailand	Local Institution	Bangkok
Turkey	Local Institution	Ankara
Turkey	Local Institution	Antalya
Turkey	Local Institution	Istanbul
Turkey	Local Institution	Izmir
Turkey	Local Institution	Kayseri
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Bristol	Avon
United Kingdom	Local Institution	Leeds	Yorkshire
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United States	3912 Taubman Center	Ann Arbor	Michigan
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Agajanian Institute Of Hematology And Oncology	Downey	California
United States	Medical Specialists Of Palm Beaches	Lake Worth	Florida
United States	Univ Of Ark For Med Sci	Little Rock	Arkansas
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	University Of Wisconsin	Madison	Wisconsin
United States	Thomas Jefferson Univ.	Philadelphia	Pennsylvania
United States	Mcguire Dvamc	Richmond	Virginia
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Va Ct Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  Czech Republic,  France,  Germany,  Hong Kong,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment		Survival will be assessed continuously	No
Secondary	To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC		Every 6 weeks	No
Secondary	To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC		Every 6 weeks	No
Secondary	To determine duration of response, duration of disease control, and time to response (TTR)		Every 6 weeks	No
Secondary	To assess the safety profile of brivanib and sorafenib		Every 6 weeks	Yes
Secondary	To explore PK and exposure-response in the study population		Every 6 weeks	No
Secondary	To compare time to symptomatic progression		Every 6 weeks	No
Secondary	To compare health-related quality of life		Every 6 weeks	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form