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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1035

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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