Clinical trial NCT01009593: Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma Non-resectable
Hepatocellular Carcinoma Recurrent
Carcinoma, Hepatocellular
Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Keywords: Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Inhibitors, Angiogenesis
Protein Kinase Inhibitors
Pharmacologic Actions
Growth Inhibitors
Angiogenesis Modulating Agents
Sorafenib
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 1035
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 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: From randomization until patient death; assessed monthly
Secondary outcomes:
measure: Time To Progression (TTP)
timeFrame: From randomization until patient progression; assessed every 6 weeks
measure: Overall Response Rate (ORR)
timeFrame: Assessed Every 6 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Site Reference ID/Investigator# 23247
state: California
city: LaVerne
country: United States
facility: Site Reference ID/Investigator# 23608
state: California
city: Orange
country: United States
facility: Site Reference ID/Investigator# 23852
state: California
city: Orange
country: United States
facility: Site Reference ID/Investigator# 40162
state: California
city: Newark
country: United States
facility: Site Reference ID/Investigator# 23254
state: Delaware
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 23253
state: Georgia
city: Honolulu
country: United States
facility: Site Reference ID/Investigator# 23609
state: Hawaii
city: Honolulu
country: United States
facility: Site Reference ID/Investigator# 24848
state: Hawaii
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 23250
state: Kentucky
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 23257
state: Missouri
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 23603
state: Nevada
city: Durham
country: United States
facility: Site Reference ID/Investigator# 23244
state: North Carolina
city: Portland
country: United States
facility: Site Reference ID/Investigator# 23252
state: Oregon
city: Buenos Aires
country: Argentina
facility: Site Reference ID/Investigator# 35705
city: Rosario, Santa Fe
country: Argentina
facility: Site Reference ID/Investigator# 35702
city: Camperdown
country: Australia
facility: Site Reference ID/Investigator# 23152
city: Concord
country: Australia
facility: Site Reference ID/Investigator# 23150
city: Kingswood
country: Australia
facility: Site Reference ID/Investigator# 27122
city: Kogarah
country: Australia
facility: Site Reference ID/Investigator# 23153
city: Southport
country: Australia
facility: Site Reference ID/Investigator# 24103
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 27968
city: Innsbruck
country: Austria
facility: Site Reference ID/Investigator# 27969
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 27970
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27967
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 38902
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 23162
city: Edegem
country: Belgium
facility: Site Reference ID/Investigator# 23843
city: Ghent
country: Belgium
facility: Site Reference ID/Investigator# 23161
city: Gilly
country: Belgium
facility: Site Reference ID/Investigator# 23842
city: Leuven
country: Belgium
facility: Site Reference ID/Investigator# 23163
city: Edmonton
country: Canada
facility: Site Reference ID/Investigator# 26702
city: Halifax
country: Canada
facility: Site Reference ID/Investigator# 25482
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 39614
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 23184
city: Sherbrooke
country: Canada
facility: Site Reference ID/Investigator# 23183
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 24522
city: Temuco
country: Chile
facility: Site Reference ID/Investigator# 36967
city: Vina del Mar
country: Chile
facility: Site Reference ID/Investigator# 36964
city: Beijing
country: China
facility: Site Reference ID/Investigator# 23186
city: Changchun
country: China
facility: Site Reference ID/Investigator# 43443
city: Chengdu
country: China
facility: Site Reference ID/Investigator# 23194
city: Chongqing
country: China
facility: Site Reference ID/Investigator# 43442
city: Dalian
country: China
facility: Site Reference ID/Investigator# 44444
city: Fuzhou
country: China
facility: Site Reference ID/Investigator# 43444
city: Guangzhou City
country: China
facility: Site Reference ID/Investigator# 43482
city: Hangzhou
country: China
facility: Site Reference ID/Investigator# 42563
city: Harbin
country: China
facility: Site Reference ID/Investigator# 44443
city: Jinan
country: China
facility: Site Reference ID/Investigator# 44062
city: Nanjing City
country: China
facility: Site Reference ID/Investigator# 23191
city: Nanning City
country: China
facility: Site Reference ID/Investigator# 44063
city: Qingdao
country: China
facility: Site Reference ID/Investigator# 42817
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 40624
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 23189
city: Suzhou
country: China
facility: Site Reference ID/Investigator# 40448
city: Xian
country: China
facility: Site Reference ID/Investigator# 23190
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 23167
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 23166
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 24523
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 23844
city: Prague 8
country: Czech Republic
facility: Site Reference ID/Investigator# 40930
city: Usti nad Labem
country: Czech Republic
facility: Site Reference ID/Investigator# 23197
city: Aarhus C
country: Denmark
facility: Site Reference ID/Investigator# 23442
city: Alexandria
country: Egypt
facility: Site Reference ID/Investigator# 23198
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 23199
city: Amiens
country: France
facility: Site Reference ID/Investigator# 43302
city: Clichy
country: France
facility: Site Reference ID/Investigator# 23201
city: Creteil
country: France
facility: Site Reference ID/Investigator# 43144
city: Lille Cedex
country: France
facility: Site Reference ID/Investigator# 23200
city: Paris Cedex 12
country: France
facility: Site Reference ID/Investigator# 23168
city: Paris Cedex 13
country: France
facility: Site Reference ID/Investigator# 40623
city: Rouen Cedex
country: France
facility: Site Reference ID/Investigator# 28345
city: Strasbourg Cedex
country: France
facility: Site Reference ID/Investigator# 23165
city: Vandoeuvre Les Nancy
country: France
facility: Site Reference ID/Investigator# 28347
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 23267
city: Bochum
country: Germany
facility: Site Reference ID/Investigator# 23845
city: Frankfurt am Main
country: Germany
facility: Site Reference ID/Investigator# 23266
city: Freiburg
country: Germany
facility: Site Reference ID/Investigator# 23268
city: Mainz
country: Germany
facility: Site Reference ID/Investigator# 23269
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 24525
city: Hong Kong
country: Hong Kong
facility: Site Reference ID/Investigator# 24980
city: Benevento
country: Italy
facility: Site Reference ID/Investigator# 27998
city: Milan
country: Italy
facility: Site Reference ID/Investigator# 23424
city: Milan
country: Italy
facility: Site Reference ID/Investigator# 41488
city: Palermo
country: Italy
facility: Site Reference ID/Investigator# 23425
city: Pavia
country: Italy
facility: Site Reference ID/Investigator# 41542
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 23428
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 24042
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 26506
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 36308
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 37602
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 29758
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 37603
city: Ibaraki-ken
country: Japan
facility: Site Reference ID/Investigator# 28189
city: Kanazawa
country: Japan
facility: Site Reference ID/Investigator# 26505
city: Kumamoto
country: Japan
facility: Site Reference ID/Investigator# 29757
city: Kurume
country: Japan
facility: Site Reference ID/Investigator# 27343
city: Matsuyama-city
country: Japan
facility: Site Reference ID/Investigator# 29759
city: Osakasayama
country: Japan
facility: Site Reference ID/Investigator# 26508
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 26507
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 27959
city: Shimotsuke
country: Japan
facility: Site Reference ID/Investigator# 29756
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 36782
city: Tochigi-ken
country: Japan
facility: Site Reference ID/Investigator# 28187
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 26503
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 27242
city: Yokohama City
country: Japan
facility: Site Reference ID/Investigator# 26504
city: Yufu
country: Japan
facility: Site Reference ID/Investigator# 26509
city: Busan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 23447
city: Busan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 39003
city: Busan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 23445
city: Daegu
country: Korea, Republic of
facility: Site Reference ID/Investigator# 23444
city: Gyeonggi-do
country: Korea, Republic of
facility: Site Reference ID/Investigator# 26543
city: Jeollanam-do
country: Korea, Republic of
facility: Site Reference ID/Investigator# 23457
city: Jeonju-si
country: Korea, Republic of
facility: Site Reference ID/Investigator# 39002
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 23454
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 25562
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 23449
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 23456
city: Suwon-si
country: Korea, Republic of
facility: Site Reference ID/Investigator# 23450
city: Kuala Lumpur
country: Malaysia
facility: Site Reference ID/Investigator# 23460
city: Penang
country: Malaysia
facility: Site Reference ID/Investigator# 23461
city: Petaling Jaya, Selangor
country: Malaysia
facility: Site Reference ID/Investigator# 23459
city: Durango, DGO.
country: Mexico
facility: Site Reference ID/Investigator# 23155
city: Monterrey, NL
country: Mexico
facility: Site Reference ID/Investigator# 43102
city: Monterrey, NL
country: Mexico
facility: Site Reference ID/Investigator# 43145
city: Amsterdam
country: Netherlands
facility: Site Reference ID/Investigator# 23272
city: Amsterdam
country: Netherlands
facility: Site Reference ID/Investigator# 23270
city: Rotterdam
country: Netherlands
facility: Site Reference ID/Investigator# 24782
city: Auckland
country: New Zealand
facility: Site Reference ID/Investigator# 23160
city: Oslo
country: Norway
facility: Site Reference ID/Investigator# 23846
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 42706
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 42705
city: Baia Mare
country: Romania
facility: Site Reference ID/Investigator# 33979
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 33344
city: Cluj Napoca
country: Romania
facility: Site Reference ID/Investigator# 33343
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 33977
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 33345
city: Oradea
country: Romania
facility: Site Reference ID/Investigator# 33346
city: Chelyabinsk
country: Russian Federation
facility: Site Reference ID/Investigator# 43202
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 43203
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 23462
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 23849
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 23159
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 23158
city: A Coruna
country: Spain
facility: Site Reference ID/Investigator# 23466
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 26063
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 40931
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 23465
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 23463
city: Santander
country: Spain
facility: Site Reference ID/Investigator# 23467
city: Zaragoza
country: Spain
facility: Site Reference ID/Investigator# 23468
city: Changhua City
country: Taiwan
facility: Site Reference ID/Investigator# 23475
city: Kaohsiung County
country: Taiwan
facility: Site Reference ID/Investigator# 23472
city: Taichung City
country: Taiwan
facility: Site Reference ID/Investigator# 25262
city: Taichung
country: Taiwan
facility: Site Reference ID/Investigator# 23474
city: Tainan
country: Taiwan
facility: Site Reference ID/Investigator# 23476
city: Tainan
country: Taiwan
facility: Site Reference ID/Investigator# 23478
city: Tainan
country: Taiwan
facility: Site Reference ID/Investigator# 23477
city: Taipei City
country: Taiwan
facility: Site Reference ID/Investigator# 23470
city: Taipei
country: Taiwan
facility: Site Reference ID/Investigator# 43237
city: Taipei
country: Taiwan
facility: Site Reference ID/Investigator# 23473
city: Taipei
country: Taiwan
facility: Site Reference ID/Investigator# 23469
city: Taoyuan
country: Taiwan
facility: Site Reference ID/Investigator# 23471
Study officials:
affiliation: Abbott
name: Justin Ricker, MD
role: STUDY_DIRECTOR
References:
citation: Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27.
citation: Cainap C, Qin S, Huang WT, Chung IJ, Pan H, Cheng Y, Kudo M, Kang YK, Chen PJ, Toh HC, Gorbunova V, Eskens FA, Qian J, McKee MD, Ricker JL, Carlson DM, El-Nowiem S. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol. 2015 Jan 10;33(2):172-9. doi: 10.1200/JCO.2013.54.3298. Epub 2014 Dec 8.