Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

Neoplasms Clinical Trial

Official title:

An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01009593
• Other study ID #: M10-963
• Secondary ID: 2009-013435-38
• Status: Terminated
• Phase: Phase 3
• First received: October 14, 2009
• Last updated: September 7, 2012
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: June 2012
• Source: Abbott
• 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 AdministrationAustria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaChile: Instituto de Salud Pública de ChileChina: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEgypt: Ministry of Health, Drug Policy and Planning CenterFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesHong Kong: Department of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthJapan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationMalaysia: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)New Zealand: MedsafeNorway: Norwegian Medicines AgencyRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSingapore: Health Sciences AuthoritySpain: Agencia Española de Medicamentos y Productos SanitariosUnited States: Food and Drug AdministrationTaiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.

Description:

The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1035
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Histologic or cytologic diagnosis with unresectable or metastatic HCC

• Child Pugh Class A

• ECOG performance status 0-1

• Adequate hematologic, hepatic, and renal function

Exclusion Criteria

• Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC

• Prior local therapy (including liver-directed therapy) within 4 weeks from entry

• Untreated brain or meningeal metastases

• Current treatment on another clinical trial

• Pregnancy or breastfeeding

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Hepatocellular Carcinoma Non-resectable
• Hepatocellular Carcinoma Recurrent
• Liver Diseases
• Liver Neoplasms
• Neoplasms
• Neoplasms by Histologic Type
• Neoplasms by Site
• Neoplasms, Glandular and Epithelial

Intervention

Drug:
• ABT-869
Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity
• Sorafenib
Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
Argentina	Site Reference ID/Investigator# 35705	Buenos Aires
Argentina	Site Reference ID/Investigator# 35702	Rosario, Santa Fe
Australia	Site Reference ID/Investigator# 23152	Camperdown
Australia	Site Reference ID/Investigator# 23150	Concord
Australia	Site Reference ID/Investigator# 27122	Kingswood
Australia	Site Reference ID/Investigator# 23153	Kogarah
Australia	Site Reference ID/Investigator# 24103	Southport
Austria	Site Reference ID/Investigator# 27968	Graz
Austria	Site Reference ID/Investigator# 27969	Innsbruck
Austria	Site Reference ID/Investigator# 27970	Linz
Austria	Site Reference ID/Investigator# 27967	Vienna
Belgium	Site Reference ID/Investigator# 23162	Brussels
Belgium	Site Reference ID/Investigator# 38902	Brussels
Belgium	Site Reference ID/Investigator# 23843	Edegem
Belgium	Site Reference ID/Investigator# 23161	Ghent
Belgium	Site Reference ID/Investigator# 23842	Gilly
Belgium	Site Reference ID/Investigator# 23163	Leuven
Canada	Site Reference ID/Investigator# 26702	Edmonton
Canada	Site Reference ID/Investigator# 25482	Halifax
Canada	Site Reference ID/Investigator# 39614	Montreal
Canada	Site Reference ID/Investigator# 23184	Ottawa
Canada	Site Reference ID/Investigator# 23183	Sherbrooke
Canada	Site Reference ID/Investigator# 24522	Toronto
Chile	Site Reference ID/Investigator# 36967	Temuco
Chile	Site Reference ID/Investigator# 36964	Vina del Mar
China	Site Reference ID/Investigator# 23186	Beijing
China	Site Reference ID/Investigator# 43443	Changchun
China	Site Reference ID/Investigator# 23194	Chengdu
China	Site Reference ID/Investigator# 43442	Chongqing
China	Site Reference ID/Investigator# 44444	Dalian
China	Site Reference ID/Investigator# 43444	Fuzhou
China	Site Reference ID/Investigator# 43482	Guangzhou City
China	Site Reference ID/Investigator# 42563	Hangzhou
China	Site Reference ID/Investigator# 44443	Harbin
China	Site Reference ID/Investigator# 44062	Jinan
China	Site Reference ID/Investigator# 23191	Nanjing City
China	Site Reference ID/Investigator# 44063	Nanning City
China	Site Reference ID/Investigator# 42817	Qingdao
China	Site Reference ID/Investigator# 23189	Shanghai
China	Site Reference ID/Investigator# 40624	Shanghai
China	Site Reference ID/Investigator# 40448	Suzhou
China	Site Reference ID/Investigator# 23190	Xian
Czech Republic	Site Reference ID/Investigator# 23167	Brno
Czech Republic	Site Reference ID/Investigator# 23166	Olomouc
Czech Republic	Site Reference ID/Investigator# 24523	Prague 2
Czech Republic	Site Reference ID/Investigator# 23844	Prague 4
Czech Republic	Site Reference ID/Investigator# 40930	Prague 8
Czech Republic	Site Reference ID/Investigator# 23197	Usti nad Labem
Denmark	Site Reference ID/Investigator# 23442	Aarhus C
Egypt	Site Reference ID/Investigator# 23198	Alexandria
Egypt	Site Reference ID/Investigator# 23199	Cairo
France	Site Reference ID/Investigator# 43302	Amiens
France	Site Reference ID/Investigator# 23201	Clichy
France	Site Reference ID/Investigator# 43144	Creteil
France	Site Reference ID/Investigator# 23200	Lille Cedex
France	Site Reference ID/Investigator# 23168	Paris Cedex 12
France	Site Reference ID/Investigator# 40623	Paris Cedex 13
France	Site Reference ID/Investigator# 28345	Rouen Cedex
France	Site Reference ID/Investigator# 23165	Strasbourg Cedex
France	Site Reference ID/Investigator# 28347	Vandoeuvre Les Nancy
Germany	Site Reference ID/Investigator# 23267	Berlin
Germany	Site Reference ID/Investigator# 23845	Bochum
Germany	Site Reference ID/Investigator# 23266	Frankfurt am Main
Germany	Site Reference ID/Investigator# 23268	Freiburg
Germany	Site Reference ID/Investigator# 23269	Mainz
Greece	Site Reference ID/Investigator# 24525	Athens
Hong Kong	Site Reference ID/Investigator# 24980	Hong Kong
Italy	Site Reference ID/Investigator# 27998	Benevento
Italy	Site Reference ID/Investigator# 23424	Milan
Italy	Site Reference ID/Investigator# 41488	Milan
Italy	Site Reference ID/Investigator# 23425	Palermo
Italy	Site Reference ID/Investigator# 41542	Pavia
Italy	Site Reference ID/Investigator# 23428	Rome
Italy	Site Reference ID/Investigator# 24042	Rome
Japan	Site Reference ID/Investigator# 26506	Aichi
Japan	Site Reference ID/Investigator# 36308	Chiba
Japan	Site Reference ID/Investigator# 37602	Chiba
Japan	Site Reference ID/Investigator# 29758	Fukuoka
Japan	Site Reference ID/Investigator# 37603	Hokkaido
Japan	Site Reference ID/Investigator# 28189	Ibaraki-ken
Japan	Site Reference ID/Investigator# 26505	Kanazawa
Japan	Site Reference ID/Investigator# 29757	Kumamoto
Japan	Site Reference ID/Investigator# 27343	Kurume
Japan	Site Reference ID/Investigator# 29759	Matsuyama-city
Japan	Site Reference ID/Investigator# 26507	Osaka
Japan	Site Reference ID/Investigator# 27959	Osaka
Japan	Site Reference ID/Investigator# 26508	Osakasayama
Japan	Site Reference ID/Investigator# 29756	Shimotsuke
Japan	Site Reference ID/Investigator# 36782	Shizuoka
Japan	Site Reference ID/Investigator# 28187	Tochigi-ken
Japan	Site Reference ID/Investigator# 26503	Tokyo
Japan	Site Reference ID/Investigator# 27242	Tokyo
Japan	Site Reference ID/Investigator# 26504	Yokohama City
Japan	Site Reference ID/Investigator# 26509	Yufu
Korea, Republic of	Site Reference ID/Investigator# 23445	Busan
Korea, Republic of	Site Reference ID/Investigator# 23447	Busan
Korea, Republic of	Site Reference ID/Investigator# 39003	Busan
Korea, Republic of	Site Reference ID/Investigator# 23444	Daegu
Korea, Republic of	Site Reference ID/Investigator# 26543	Gyeonggi-do
Korea, Republic of	Site Reference ID/Investigator# 23457	Jeollanam-do
Korea, Republic of	Site Reference ID/Investigator# 39002	Jeonju-si
Korea, Republic of	Site Reference ID/Investigator# 23449	Seoul
Korea, Republic of	Site Reference ID/Investigator# 23454	Seoul
Korea, Republic of	Site Reference ID/Investigator# 23456	Seoul
Korea, Republic of	Site Reference ID/Investigator# 25562	Seoul
Korea, Republic of	Site Reference ID/Investigator# 23450	Suwon-si
Malaysia	Site Reference ID/Investigator# 23460	Kuala Lumpur
Malaysia	Site Reference ID/Investigator# 23461	Penang
Malaysia	Site Reference ID/Investigator# 23459	Petaling Jaya, Selangor
Mexico	Site Reference ID/Investigator# 23155	Durango, DGO.
Mexico	Site Reference ID/Investigator# 43102	Monterrey, NL
Mexico	Site Reference ID/Investigator# 43145	Monterrey, NL
Netherlands	Site Reference ID/Investigator# 23270	Amsterdam
Netherlands	Site Reference ID/Investigator# 23272	Amsterdam
Netherlands	Site Reference ID/Investigator# 24782	Rotterdam
New Zealand	Site Reference ID/Investigator# 23160	Auckland
Norway	Site Reference ID/Investigator# 23846	Oslo
Puerto Rico	Site Reference ID/Investigator# 42706	Ponce
Puerto Rico	Site Reference ID/Investigator# 42705	San Juan
Romania	Site Reference ID/Investigator# 33979	Baia Mare
Romania	Site Reference ID/Investigator# 33344	Bucharest
Romania	Site Reference ID/Investigator# 33343	Cluj Napoca
Romania	Site Reference ID/Investigator# 33977	Craiova
Romania	Site Reference ID/Investigator# 33345	Iasi
Romania	Site Reference ID/Investigator# 33346	Oradea
Russian Federation	Site Reference ID/Investigator# 43202	Chelyabinsk
Russian Federation	Site Reference ID/Investigator# 43203	Kazan
Russian Federation	Site Reference ID/Investigator# 23462	Moscow
Russian Federation	Site Reference ID/Investigator# 23849	Moscow
Singapore	Site Reference ID/Investigator# 23158	Singapore
Singapore	Site Reference ID/Investigator# 23159	Singapore
Spain	Site Reference ID/Investigator# 23466	A Coruna
Spain	Site Reference ID/Investigator# 23463	Madrid
Spain	Site Reference ID/Investigator# 23465	Madrid
Spain	Site Reference ID/Investigator# 26063	Madrid
Spain	Site Reference ID/Investigator# 40931	Madrid
Spain	Site Reference ID/Investigator# 23467	Santander
Spain	Site Reference ID/Investigator# 23468	Zaragoza
Taiwan	Site Reference ID/Investigator# 23475	Changhua City
Taiwan	Site Reference ID/Investigator# 23472	Kaohsiung County
Taiwan	Site Reference ID/Investigator# 23474	Taichung
Taiwan	Site Reference ID/Investigator# 25262	Taichung City
Taiwan	Site Reference ID/Investigator# 23476	Tainan
Taiwan	Site Reference ID/Investigator# 23477	Tainan
Taiwan	Site Reference ID/Investigator# 23478	Tainan
Taiwan	Site Reference ID/Investigator# 23469	Taipei
Taiwan	Site Reference ID/Investigator# 23473	Taipei
Taiwan	Site Reference ID/Investigator# 43237	Taipei
Taiwan	Site Reference ID/Investigator# 23470	Taipei City
Taiwan	Site Reference ID/Investigator# 23471	Taoyuan
United States	Site Reference ID/Investigator# 23247	Beverly Hills	California
United States	Site Reference ID/Investigator# 23244	Durham	North Carolina
United States	Site Reference ID/Investigator# 23253	Gainesville	Georgia
United States	Site Reference ID/Investigator# 23609	Honolulu	Hawaii
United States	Site Reference ID/Investigator# 24848	Honolulu	Hawaii
United States	Site Reference ID/Investigator# 23603	Las Vegas	Nevada
United States	Site Reference ID/Investigator# 23608	LaVerne	California
United States	Site Reference ID/Investigator# 23250	Louisville	Kentucky
United States	Site Reference ID/Investigator# 23254	Newark	Delaware
United States	Site Reference ID/Investigator# 23852	Orange	California
United States	Site Reference ID/Investigator# 40162	Orange	California
United States	Site Reference ID/Investigator# 23252	Portland	Oregon
United States	Site Reference ID/Investigator# 23257	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Chile,  China,  Czech Republic,  Denmark,  Egypt,  France,  Germany,  Greece,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		From randomization until patient death; assessed monthly	No
Secondary	Time To Progression (TTP)		From randomization until patient progression; assessed every 6 weeks	No
Secondary	Overall Response Rate (ORR)		Assessed Every 6 weeks	No