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

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01009593
First received: October 14, 2009
Last updated: September 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
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
Drug: ABT-869
Drug: Sorafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization until patient death; assessed monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time To Progression (TTP) [ Time Frame: From randomization until patient progression; assessed every 6 weeks ] [ Designated as safety issue: No ]
  • Overall Response Rate (ORR) [ Time Frame: Assessed Every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 1035
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-869 Drug: ABT-869
Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity
Other Name: ABT-869
Active Comparator: Sorafenib Drug: Sorafenib
Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
Other Name: Sorafenib

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009593

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01009593     History of Changes
Other Study ID Numbers: M10-963, 2009-013435-38
Study First Received: October 14, 2009
Last Updated: September 7, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health, Drug Policy and Planning Center
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Abbott:
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

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Carcinoma
Digestive System Diseases
Gastrointestinal Diseases
Digestive System Neoplasms
Gastrointestinal Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Carcinoma, Hepatocellular
Sorafenib
Antineoplastic Agents
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Angiogenesis Modulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Therapeutic Uses
Pharmacologic Actions
Growth Substances
Growth Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014