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

Primary Purpose

Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma Recurrent, Carcinoma, Hepatocellular

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABT-869
Sorafenib
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 23247
  • Site Reference ID/Investigator# 23608
  • Site Reference ID/Investigator# 23852
  • Site Reference ID/Investigator# 40162
  • Site Reference ID/Investigator# 23254
  • Site Reference ID/Investigator# 23253
  • Site Reference ID/Investigator# 23609
  • Site Reference ID/Investigator# 24848
  • Site Reference ID/Investigator# 23250
  • Site Reference ID/Investigator# 23257
  • Site Reference ID/Investigator# 23603
  • Site Reference ID/Investigator# 23244
  • Site Reference ID/Investigator# 23252
  • Site Reference ID/Investigator# 35705
  • Site Reference ID/Investigator# 35702
  • Site Reference ID/Investigator# 23152
  • Site Reference ID/Investigator# 23150
  • Site Reference ID/Investigator# 27122
  • Site Reference ID/Investigator# 23153
  • Site Reference ID/Investigator# 24103
  • Site Reference ID/Investigator# 27968
  • Site Reference ID/Investigator# 27969
  • Site Reference ID/Investigator# 27970
  • Site Reference ID/Investigator# 27967
  • Site Reference ID/Investigator# 38902
  • Site Reference ID/Investigator# 23162
  • Site Reference ID/Investigator# 23843
  • Site Reference ID/Investigator# 23161
  • Site Reference ID/Investigator# 23842
  • Site Reference ID/Investigator# 23163
  • Site Reference ID/Investigator# 26702
  • Site Reference ID/Investigator# 25482
  • Site Reference ID/Investigator# 39614
  • Site Reference ID/Investigator# 23184
  • Site Reference ID/Investigator# 23183
  • Site Reference ID/Investigator# 24522
  • Site Reference ID/Investigator# 36967
  • Site Reference ID/Investigator# 36964
  • Site Reference ID/Investigator# 23186
  • Site Reference ID/Investigator# 43443
  • Site Reference ID/Investigator# 23194
  • Site Reference ID/Investigator# 43442
  • Site Reference ID/Investigator# 44444
  • Site Reference ID/Investigator# 43444
  • Site Reference ID/Investigator# 43482
  • Site Reference ID/Investigator# 42563
  • Site Reference ID/Investigator# 44443
  • Site Reference ID/Investigator# 44062
  • Site Reference ID/Investigator# 23191
  • Site Reference ID/Investigator# 44063
  • Site Reference ID/Investigator# 42817
  • Site Reference ID/Investigator# 40624
  • Site Reference ID/Investigator# 23189
  • Site Reference ID/Investigator# 40448
  • Site Reference ID/Investigator# 23190
  • Site Reference ID/Investigator# 23167
  • Site Reference ID/Investigator# 23166
  • Site Reference ID/Investigator# 24523
  • Site Reference ID/Investigator# 23844
  • Site Reference ID/Investigator# 40930
  • Site Reference ID/Investigator# 23197
  • Site Reference ID/Investigator# 23442
  • Site Reference ID/Investigator# 23198
  • Site Reference ID/Investigator# 23199
  • Site Reference ID/Investigator# 43302
  • Site Reference ID/Investigator# 23201
  • Site Reference ID/Investigator# 43144
  • Site Reference ID/Investigator# 23200
  • Site Reference ID/Investigator# 23168
  • Site Reference ID/Investigator# 40623
  • Site Reference ID/Investigator# 28345
  • Site Reference ID/Investigator# 23165
  • Site Reference ID/Investigator# 28347
  • Site Reference ID/Investigator# 23267
  • Site Reference ID/Investigator# 23845
  • Site Reference ID/Investigator# 23266
  • Site Reference ID/Investigator# 23268
  • Site Reference ID/Investigator# 23269
  • Site Reference ID/Investigator# 24525
  • Site Reference ID/Investigator# 24980
  • Site Reference ID/Investigator# 27998
  • Site Reference ID/Investigator# 23424
  • Site Reference ID/Investigator# 41488
  • Site Reference ID/Investigator# 23425
  • Site Reference ID/Investigator# 41542
  • Site Reference ID/Investigator# 23428
  • Site Reference ID/Investigator# 24042
  • Site Reference ID/Investigator# 26506
  • Site Reference ID/Investigator# 36308
  • Site Reference ID/Investigator# 37602
  • Site Reference ID/Investigator# 29758
  • Site Reference ID/Investigator# 37603
  • Site Reference ID/Investigator# 28189
  • Site Reference ID/Investigator# 26505
  • Site Reference ID/Investigator# 29757
  • Site Reference ID/Investigator# 27343
  • Site Reference ID/Investigator# 29759
  • Site Reference ID/Investigator# 26508
  • Site Reference ID/Investigator# 26507
  • Site Reference ID/Investigator# 27959
  • Site Reference ID/Investigator# 29756
  • Site Reference ID/Investigator# 36782
  • Site Reference ID/Investigator# 28187
  • Site Reference ID/Investigator# 26503
  • Site Reference ID/Investigator# 27242
  • Site Reference ID/Investigator# 26504
  • Site Reference ID/Investigator# 26509
  • Site Reference ID/Investigator# 23447
  • Site Reference ID/Investigator# 39003
  • Site Reference ID/Investigator# 23445
  • Site Reference ID/Investigator# 23444
  • Site Reference ID/Investigator# 26543
  • Site Reference ID/Investigator# 23457
  • Site Reference ID/Investigator# 39002
  • Site Reference ID/Investigator# 23454
  • Site Reference ID/Investigator# 25562
  • Site Reference ID/Investigator# 23449
  • Site Reference ID/Investigator# 23456
  • Site Reference ID/Investigator# 23450
  • Site Reference ID/Investigator# 23460
  • Site Reference ID/Investigator# 23461
  • Site Reference ID/Investigator# 23459
  • Site Reference ID/Investigator# 23155
  • Site Reference ID/Investigator# 43102
  • Site Reference ID/Investigator# 43145
  • Site Reference ID/Investigator# 23272
  • Site Reference ID/Investigator# 23270
  • Site Reference ID/Investigator# 24782
  • Site Reference ID/Investigator# 23160
  • Site Reference ID/Investigator# 23846
  • Site Reference ID/Investigator# 42706
  • Site Reference ID/Investigator# 42705
  • Site Reference ID/Investigator# 33979
  • Site Reference ID/Investigator# 33344
  • Site Reference ID/Investigator# 33343
  • Site Reference ID/Investigator# 33977
  • Site Reference ID/Investigator# 33345
  • Site Reference ID/Investigator# 33346
  • Site Reference ID/Investigator# 43202
  • Site Reference ID/Investigator# 43203
  • Site Reference ID/Investigator# 23462
  • Site Reference ID/Investigator# 23849
  • Site Reference ID/Investigator# 23159
  • Site Reference ID/Investigator# 23158
  • Site Reference ID/Investigator# 23466
  • Site Reference ID/Investigator# 26063
  • Site Reference ID/Investigator# 40931
  • Site Reference ID/Investigator# 23465
  • Site Reference ID/Investigator# 23463
  • Site Reference ID/Investigator# 23467
  • Site Reference ID/Investigator# 23468
  • Site Reference ID/Investigator# 23475
  • Site Reference ID/Investigator# 23472
  • Site Reference ID/Investigator# 25262
  • Site Reference ID/Investigator# 23474
  • Site Reference ID/Investigator# 23476
  • Site Reference ID/Investigator# 23478
  • Site Reference ID/Investigator# 23477
  • Site Reference ID/Investigator# 23470
  • Site Reference ID/Investigator# 43237
  • Site Reference ID/Investigator# 23473
  • Site Reference ID/Investigator# 23469
  • Site Reference ID/Investigator# 23471

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABT-869

Sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Time To Progression (TTP)
Overall Response Rate (ORR)

Full Information

First Posted
October 14, 2009
Last Updated
September 7, 2012
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01009593
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1035 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-869
Arm Type
Experimental
Arm Title
Sorafenib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ABT-869
Intervention Description
Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
From randomization until patient death; assessed monthly
Secondary Outcome Measure Information:
Title
Time To Progression (TTP)
Time Frame
From randomization until patient progression; assessed every 6 weeks
Title
Overall Response Rate (ORR)
Time Frame
Assessed Every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ricker, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 23247
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1850
Country
United States
Facility Name
Site Reference ID/Investigator# 23608
City
LaVerne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Site Reference ID/Investigator# 23852
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site Reference ID/Investigator# 40162
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site Reference ID/Investigator# 23254
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Site Reference ID/Investigator# 23253
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30505
Country
United States
Facility Name
Site Reference ID/Investigator# 23609
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Site Reference ID/Investigator# 24848
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Site Reference ID/Investigator# 23250
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Site Reference ID/Investigator# 23257
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Site Reference ID/Investigator# 23603
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Site Reference ID/Investigator# 23244
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Site Reference ID/Investigator# 23252
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Site Reference ID/Investigator# 35705
City
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Facility Name
Site Reference ID/Investigator# 35702
City
Rosario, Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Site Reference ID/Investigator# 23152
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Site Reference ID/Investigator# 23150
City
Concord
ZIP/Postal Code
2139
Country
Australia
Facility Name
Site Reference ID/Investigator# 27122
City
Kingswood
ZIP/Postal Code
2747
Country
Australia
Facility Name
Site Reference ID/Investigator# 23153
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Site Reference ID/Investigator# 24103
City
Southport
ZIP/Postal Code
4215
Country
Australia
Facility Name
Site Reference ID/Investigator# 27968
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Site Reference ID/Investigator# 27969
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Site Reference ID/Investigator# 27970
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Site Reference ID/Investigator# 27967
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Site Reference ID/Investigator# 38902
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Site Reference ID/Investigator# 23162
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Site Reference ID/Investigator# 23843
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Site Reference ID/Investigator# 23161
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 23842
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Site Reference ID/Investigator# 23163
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 26702
City
Edmonton
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Site Reference ID/Investigator# 25482
City
Halifax
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Site Reference ID/Investigator# 39614
City
Montreal
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Site Reference ID/Investigator# 23184
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Site Reference ID/Investigator# 23183
City
Sherbrooke
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
Site Reference ID/Investigator# 24522
City
Toronto
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Site Reference ID/Investigator# 36967
City
Temuco
ZIP/Postal Code
01745
Country
Chile
Facility Name
Site Reference ID/Investigator# 36964
City
Vina del Mar
Country
Chile
Facility Name
Site Reference ID/Investigator# 23186
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Site Reference ID/Investigator# 43443
City
Changchun
ZIP/Postal Code
130012
Country
China
Facility Name
Site Reference ID/Investigator# 23194
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Site Reference ID/Investigator# 43442
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Site Reference ID/Investigator# 44444
City
Dalian
ZIP/Postal Code
116011
Country
China
Facility Name
Site Reference ID/Investigator# 43444
City
Fuzhou
ZIP/Postal Code
350025
Country
China
Facility Name
Site Reference ID/Investigator# 43482
City
Guangzhou City
ZIP/Postal Code
510515
Country
China
Facility Name
Site Reference ID/Investigator# 42563
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Site Reference ID/Investigator# 44443
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Site Reference ID/Investigator# 44062
City
Jinan
ZIP/Postal Code
250031
Country
China
Facility Name
Site Reference ID/Investigator# 23191
City
Nanjing City
ZIP/Postal Code
210002
Country
China
Facility Name
Site Reference ID/Investigator# 44063
City
Nanning City
ZIP/Postal Code
530021
Country
China
Facility Name
Site Reference ID/Investigator# 42817
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
Site Reference ID/Investigator# 40624
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Site Reference ID/Investigator# 23189
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Site Reference ID/Investigator# 40448
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
Site Reference ID/Investigator# 23190
City
Xian
ZIP/Postal Code
710032
Country
China
Facility Name
Site Reference ID/Investigator# 23167
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 23166
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 24523
City
Prague 2
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 23844
City
Prague 4
ZIP/Postal Code
14021
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 40930
City
Prague 8
ZIP/Postal Code
18081
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 23197
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 23442
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Site Reference ID/Investigator# 23198
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Site Reference ID/Investigator# 23199
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Facility Name
Site Reference ID/Investigator# 43302
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Site Reference ID/Investigator# 23201
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Site Reference ID/Investigator# 43144
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Site Reference ID/Investigator# 23200
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Site Reference ID/Investigator# 23168
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Site Reference ID/Investigator# 40623
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Site Reference ID/Investigator# 28345
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Site Reference ID/Investigator# 23165
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Site Reference ID/Investigator# 28347
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Site Reference ID/Investigator# 23267
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Site Reference ID/Investigator# 23845
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Site Reference ID/Investigator# 23266
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Site Reference ID/Investigator# 23268
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Site Reference ID/Investigator# 23269
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Site Reference ID/Investigator# 24525
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Site Reference ID/Investigator# 24980
City
Hong Kong
Country
Hong Kong
Facility Name
Site Reference ID/Investigator# 27998
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Site Reference ID/Investigator# 23424
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Site Reference ID/Investigator# 41488
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Site Reference ID/Investigator# 23425
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Site Reference ID/Investigator# 41542
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Site Reference ID/Investigator# 23428
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Site Reference ID/Investigator# 24042
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Site Reference ID/Investigator# 26506
City
Aichi
Country
Japan
Facility Name
Site Reference ID/Investigator# 36308
City
Chiba
Country
Japan
Facility Name
Site Reference ID/Investigator# 37602
City
Chiba
Country
Japan
Facility Name
Site Reference ID/Investigator# 29758
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 37603
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 28189
City
Ibaraki-ken
Country
Japan
Facility Name
Site Reference ID/Investigator# 26505
City
Kanazawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 29757
City
Kumamoto
Country
Japan
Facility Name
Site Reference ID/Investigator# 27343
City
Kurume
Country
Japan
Facility Name
Site Reference ID/Investigator# 29759
City
Matsuyama-city
Country
Japan
Facility Name
Site Reference ID/Investigator# 26508
City
Osakasayama
Country
Japan
Facility Name
Site Reference ID/Investigator# 26507
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 27959
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 29756
City
Shimotsuke
Country
Japan
Facility Name
Site Reference ID/Investigator# 36782
City
Shizuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 28187
City
Tochigi-ken
Country
Japan
Facility Name
Site Reference ID/Investigator# 26503
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 27242
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 26504
City
Yokohama City
Country
Japan
Facility Name
Site Reference ID/Investigator# 26509
City
Yufu
Country
Japan
Facility Name
Site Reference ID/Investigator# 23447
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 39003
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 23445
City
Busan
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 23444
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 26543
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 23457
City
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 39002
City
Jeonju-si
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 23454
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 25562
City
Seoul
ZIP/Postal Code
138-701
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 23449
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 23456
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 23450
City
Suwon-si
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Site Reference ID/Investigator# 23460
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Site Reference ID/Investigator# 23461
City
Penang
ZIP/Postal Code
11200
Country
Malaysia
Facility Name
Site Reference ID/Investigator# 23459
City
Petaling Jaya, Selangor
ZIP/Postal Code
46050
Country
Malaysia
Facility Name
Site Reference ID/Investigator# 23155
City
Durango, DGO.
ZIP/Postal Code
CP 34000
Country
Mexico
Facility Name
Site Reference ID/Investigator# 43102
City
Monterrey, NL
ZIP/Postal Code
CP 64000
Country
Mexico
Facility Name
Site Reference ID/Investigator# 43145
City
Monterrey, NL
ZIP/Postal Code
CP 64020
Country
Mexico
Facility Name
Site Reference ID/Investigator# 23272
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 23270
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 24782
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 23160
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Site Reference ID/Investigator# 23846
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Site Reference ID/Investigator# 42706
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 42705
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 33979
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Site Reference ID/Investigator# 33344
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Site Reference ID/Investigator# 33343
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Site Reference ID/Investigator# 33977
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
Site Reference ID/Investigator# 33345
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Site Reference ID/Investigator# 33346
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
Site Reference ID/Investigator# 43202
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 43203
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 23462
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 23849
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 23159
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Site Reference ID/Investigator# 23158
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Site Reference ID/Investigator# 23466
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Site Reference ID/Investigator# 26063
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Site Reference ID/Investigator# 40931
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Site Reference ID/Investigator# 23465
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Site Reference ID/Investigator# 23463
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Site Reference ID/Investigator# 23467
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Site Reference ID/Investigator# 23468
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Site Reference ID/Investigator# 23475
City
Changhua City
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23472
City
Kaohsiung County
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 25262
City
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23474
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23476
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23478
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23477
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23470
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 43237
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23473
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23469
City
Taipei
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 23471
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34052255
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.
Results Reference
derived
PubMed Identifier
25488963
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. Erratum In: J Clin Oncol. 2017 Aug 1;35(22):2590.
Results Reference
derived

Learn more about this trial

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

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