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

September 7, 2012 updated by: Abbott

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1035

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sorafenib
Drug: Sorafenib
Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
Experimental: ABT-869
Drug: ABT-869
Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From randomization until patient death; assessed monthly
From randomization until patient death; assessed monthly

Secondary Outcome Measures

Outcome Measure
Time Frame
Time To Progression (TTP)
Time Frame: From randomization until patient progression; assessed every 6 weeks
From randomization until patient progression; assessed every 6 weeks
Overall Response Rate (ORR)
Time Frame: Assessed Every 6 weeks
Assessed Every 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Justin Ricker, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-963
  • 2009-013435-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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