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AzTrials

Hepatocellular Carcinoma Non-resectablePhase 3NCT01009593

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

A Phase 3 study testing ABT-869 and Sorafenib in people with Hepatocellular Carcinoma Non-resectable and Hepatocellular Carcinoma Recurrent, run by Abbott at 163 sites in 29 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABT-869 and Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,035 participants
Where
163 sitesin 29 countries
Study dates
Jan 2010to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic or cytologic diagnosis with unresectable or metastatic HCC
  • Child Pugh Class A
  • ECOG performance status 0-1
  • Adequate hematologic, hepatic, and renal function

Who cannot join

  • 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

Trial locations and contacts

163 sites in 29 countries.

163 sites in 29 countries

Japan20 sites

  • Site Reference ID/Investigator# 26506

    Aichi

  • Site Reference ID/Investigator# 36308

    Chiba

  • Site Reference ID/Investigator# 37602

    Chiba

  • Site Reference ID/Investigator# 29758

    Fukuoka

  • Site Reference ID/Investigator# 37603

    Hokkaido

  • Site Reference ID/Investigator# 28189

    Ibaraki-ken

  • Site Reference ID/Investigator# 26505

    Kanazawa

  • Site Reference ID/Investigator# 29757

    Kumamoto

  • Site Reference ID/Investigator# 27343

    Kurume

  • Site Reference ID/Investigator# 29759

    Matsuyama

  • Site Reference ID/Investigator# 26507

    Osaka

  • Site Reference ID/Investigator# 27959

    Osaka

  • Site Reference ID/Investigator# 26508

    Sayama

  • Site Reference ID/Investigator# 29756

    Shimotsuke

  • Site Reference ID/Investigator# 36782

    Shizuoka

  • Site Reference ID/Investigator# 28187

    Tochigi-ken

  • Site Reference ID/Investigator# 26503

    Tokyo

  • Site Reference ID/Investigator# 27242

    Tokyo

  • Site Reference ID/Investigator# 26504

    Yokohama

  • Site Reference ID/Investigator# 26509

    Yufu

Other trials in Japan

China17 sites

  • Site Reference ID/Investigator# 23186

    Beijing, 100071

  • Site Reference ID/Investigator# 43443

    Changchun, 130012

  • Site Reference ID/Investigator# 23194

    Chengdu, 610041

  • Site Reference ID/Investigator# 43442

    Chongqing, 400038

  • Site Reference ID/Investigator# 44444

    Dalian, 116011

  • Site Reference ID/Investigator# 43444

    Fuzhou, 350025

  • Site Reference ID/Investigator# 43482

    Guangzhou, 510515

  • Site Reference ID/Investigator# 42563

    Hangzhou, 310016

  • Site Reference ID/Investigator# 44443

    Harbin, 150081

  • Site Reference ID/Investigator# 44062

    Jinan, 250031

  • Site Reference ID/Investigator# 23191

    Nanjing, 210002

  • Site Reference ID/Investigator# 44063

    Nanning, 530021

  • Site Reference ID/Investigator# 42817

    Qingdao, 266003

  • Site Reference ID/Investigator# 40624

    Shanghai, 200032

  • Site Reference ID/Investigator# 23189

    Shanghai, 200080

  • Site Reference ID/Investigator# 40448

    Suzhou, 215006

  • Site Reference ID/Investigator# 23190

    Xi'an, 710032

Other trials in China

United States13 sites

  • Site Reference ID/Investigator# 23247

    Beverly Hills, California, 90211-1850

  • Site Reference ID/Investigator# 23244

    Durham, North Carolina, 27710

  • Site Reference ID/Investigator# 23253

    Gainesville, Georgia, 30505

  • Site Reference ID/Investigator# 23609

    Honolulu, Hawaii, 96813

  • Site Reference ID/Investigator# 24848

    Honolulu, Hawaii, 96819

  • Site Reference ID/Investigator# 23603

    Las Vegas, Nevada, 89135

  • Site Reference ID/Investigator# 23608

    LaVerne, California, 91750

  • Site Reference ID/Investigator# 23250

    Louisville, Kentucky, 40202

  • Site Reference ID/Investigator# 23254

    Newark, Delaware, 19713

  • Site Reference ID/Investigator# 23852

    Orange, California, 92868

  • Site Reference ID/Investigator# 40162

    Orange, California, 92868

  • Site Reference ID/Investigator# 23252

    Portland, Oregon, 97213

  • Site Reference ID/Investigator# 23257

    St Louis, Missouri, 63104

Other trials in United States

South Korea12 sites

  • Site Reference ID/Investigator# 23447

    Busan, 602-715

  • Site Reference ID/Investigator# 39003

    Busan, 614-735

  • Site Reference ID/Investigator# 23445

    Busan, 626-770

  • Site Reference ID/Investigator# 23444

    Daegu, 700-721

  • Site Reference ID/Investigator# 26543

    Gyeonggi-do, 410-769

  • Site Reference ID/Investigator# 23457

    Jeollanam-do, 519-809

  • Site Reference ID/Investigator# 39002

    Jeonju, 561-712

  • Site Reference ID/Investigator# 23454

    Seoul, 120-752

  • Site Reference ID/Investigator# 25562

    Seoul, 138-701

  • Site Reference ID/Investigator# 23449

    Seoul, 138-736

  • Site Reference ID/Investigator# 23456

    Seoul, 152-703

  • Site Reference ID/Investigator# 23450

    Suwon, 443-721

Other trials in South Korea

Taiwan12 sites

  • Site Reference ID/Investigator# 23475

    Changhua, 500

  • Site Reference ID/Investigator# 23472

    Kaohsiung County, 833

  • Site Reference ID/Investigator# 25262

    Taichung, 404

  • Site Reference ID/Investigator# 23474

    Taichung, 40705

  • Site Reference ID/Investigator# 23476

    Tainan, 704

  • Site Reference ID/Investigator# 23478

    Tainan, 710

  • Site Reference ID/Investigator# 23477

    Tainan, 736

  • Site Reference ID/Investigator# 23470

    Taipei, 10449

  • Site Reference ID/Investigator# 43237

    Taipei, 110

  • Site Reference ID/Investigator# 23473

    Taipei, 112

  • Site Reference ID/Investigator# 23469

    Taipei

  • Site Reference ID/Investigator# 23471

    Taoyuan, 333

Other trials in Taiwan

France9 sites

  • Site Reference ID/Investigator# 43302

    Amiens, 80054

  • Site Reference ID/Investigator# 23201

    Clichy, 92118

  • Site Reference ID/Investigator# 43144

    Créteil, 94010

  • Site Reference ID/Investigator# 23200

    Lille, 59037

  • Site Reference ID/Investigator# 23168

    Paris, 75571

  • Site Reference ID/Investigator# 40623

    Paris, 75651

  • Site Reference ID/Investigator# 28345

    Rouen, 76031

  • Site Reference ID/Investigator# 23165

    Strasbourg, 67091

  • Site Reference ID/Investigator# 28347

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy7 sites

  • Site Reference ID/Investigator# 27998

    Benevento, 82100

  • Site Reference ID/Investigator# 23424

    Milan, 20122

  • Site Reference ID/Investigator# 41488

    Milan, 20132

  • Site Reference ID/Investigator# 23425

    Palermo, 90127

  • Site Reference ID/Investigator# 41542

    Pavia, 27100

  • Site Reference ID/Investigator# 23428

    Rome, 00144

  • Site Reference ID/Investigator# 24042

    Rome, 00168

Other trials in Italy

Spain7 sites

  • Site Reference ID/Investigator# 23466

    A Coruña, 15006

  • Site Reference ID/Investigator# 26063

    Madrid, 28007

  • Site Reference ID/Investigator# 40931

    Madrid, 28033

  • Site Reference ID/Investigator# 23465

    Madrid, 28034

  • Site Reference ID/Investigator# 23463

    Madrid, 28050

  • Site Reference ID/Investigator# 23467

    Santander, 39008

  • Site Reference ID/Investigator# 23468

    Zaragoza, 50009

Other trials in Spain

Belgium6 sites

  • Site Reference ID/Investigator# 38902

    Brussels, 1070

  • Site Reference ID/Investigator# 23162

    Brussels, 1200

  • Site Reference ID/Investigator# 23843

    Edegem, 2650

  • Site Reference ID/Investigator# 23161

    Ghent, 9000

  • Site Reference ID/Investigator# 23842

    Gilly, 6060

  • Site Reference ID/Investigator# 23163

    Leuven, 3000

Other trials in Belgium

Canada6 sites

  • Site Reference ID/Investigator# 26702

    Edmonton, T6G 2X8

  • Site Reference ID/Investigator# 25482

    Halifax, B3H 2Y9

  • Site Reference ID/Investigator# 39614

    Montreal, H2X 3J4

  • Site Reference ID/Investigator# 23184

    Ottawa, K1H 8L6

  • Site Reference ID/Investigator# 23183

    Sherbrooke, J1G 2E8

  • Site Reference ID/Investigator# 24522

    Toronto, M4C 3E7

Other trials in Canada

Czechia6 sites

  • Site Reference ID/Investigator# 23167

    Brno, 625 00

  • Site Reference ID/Investigator# 23166

    Olomouc, 775 20

  • Site Reference ID/Investigator# 24523

    Prague, 12808

  • Site Reference ID/Investigator# 23844

    Prague, 14021

  • Site Reference ID/Investigator# 40930

    Prague, 18081

  • Site Reference ID/Investigator# 23197

    Ústí nad Labem, 401 13

Other trials in Czechia

Romania6 sites

  • Site Reference ID/Investigator# 33979

    Baia Mare, 430031

  • Site Reference ID/Investigator# 33344

    Bucharest, 022328

  • Site Reference ID/Investigator# 33343

    Cluj-Napoca, 400015

  • Site Reference ID/Investigator# 33977

    Craiova, 200385

  • Site Reference ID/Investigator# 33345

    Iași, 700106

  • Site Reference ID/Investigator# 33346

    Oradea, 410469

Other trials in Romania

Australia5 sites

  • Site Reference ID/Investigator# 23152

    Camperdown, 2050

  • Site Reference ID/Investigator# 23150

    Concord, 2139

  • Site Reference ID/Investigator# 27122

    Kingswood, 2747

  • Site Reference ID/Investigator# 23153

    Kogarah, 2217

  • Site Reference ID/Investigator# 24103

    Southport, 4215

Other trials in Australia

Germany5 sites

  • Site Reference ID/Investigator# 23267

    Berlin, 13353

  • Site Reference ID/Investigator# 23845

    Bochum, 44789

  • Site Reference ID/Investigator# 23266

    Frankfurt am Main, 60590

  • Site Reference ID/Investigator# 23268

    Freiburg im Breisgau, 79106

  • Site Reference ID/Investigator# 23269

    Mainz, 55131

Other trials in Germany

Austria4 sites

  • Site Reference ID/Investigator# 27968

    Graz, 8036

  • Site Reference ID/Investigator# 27969

    Innsbruck, A-6020

  • Site Reference ID/Investigator# 27970

    Linz, 4020

  • Site Reference ID/Investigator# 27967

    Vienna, 1090

Other trials in Austria

Russia4 sites

  • Site Reference ID/Investigator# 43202

    Chelyabinsk, 454087

  • Site Reference ID/Investigator# 43203

    Kazan', 420029

  • Site Reference ID/Investigator# 23462

    Moscow, 115478

  • Site Reference ID/Investigator# 23849

    Moscow, 115478

Other trials in Russia

Malaysia3 sites

  • Site Reference ID/Investigator# 23461

    George Town, 11200

  • Site Reference ID/Investigator# 23460

    Kuala Lumpur, 50603

  • Site Reference ID/Investigator# 23459

    Petaling Jaya, Selangor, 46050

Other trials in Malaysia

Mexico3 sites

  • Site Reference ID/Investigator# 23155

    Durango, DGO., CP 34000

  • Site Reference ID/Investigator# 43102

    Monterrey, NL, CP 64000

  • Site Reference ID/Investigator# 43145

    Monterrey, NL, CP 64020

Other trials in Mexico

Netherlands3 sites

  • Site Reference ID/Investigator# 23272

    Amsterdam, 1081 HV

  • Site Reference ID/Investigator# 23270

    Amsterdam, 1105 AZ

  • Site Reference ID/Investigator# 24782

    Rotterdam, 3015 CE

Other trials in Netherlands

Argentina2 sites

  • Site Reference ID/Investigator# 35705

    Buenos Aires, B1629ODT

  • Site Reference ID/Investigator# 35702

    Rosario, Santa Fe, S2002KDS

Other trials in Argentina

Chile2 sites

  • Site Reference ID/Investigator# 36967

    Temuco, 01745

  • Site Reference ID/Investigator# 36964

    Viña del Mar

Other trials in Chile

Egypt2 sites

  • Site Reference ID/Investigator# 23198

    Alexandria, 21131

  • Site Reference ID/Investigator# 23199

    Cairo, 11796

Other trials in Egypt

Puerto Rico2 sites

  • Site Reference ID/Investigator# 42706

    Ponce, 00716

  • Site Reference ID/Investigator# 42705

    San Juan, 00936-5067

Other trials in Puerto Rico

Singapore2 sites

  • Site Reference ID/Investigator# 23159

    Singapore, 119228

  • Site Reference ID/Investigator# 23158

    Singapore, 169610

Other trials in Singapore

Denmark1 site

  • Site Reference ID/Investigator# 23442

    Aarhus C, 8000

Other trials in Denmark

Greece1 site

  • Site Reference ID/Investigator# 24525

    Athens, 115 27

Other trials in Greece

Hong Kong1 site

  • Site Reference ID/Investigator# 24980

    Hong Kong

Other trials in Hong Kong

New Zealand1 site

  • Site Reference ID/Investigator# 23160

    Auckland, 1142

Other trials in New Zealand

Norway1 site

  • Site Reference ID/Investigator# 23846

    Oslo, 0407

Other trials in Norway

About this study

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)

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.

Read the detailed description

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

Being tested
ABT-869, Sorafenib
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
Medical subject headings
Carcinoma, Hepatocellular, Liver Diseases, Neoplasms by Histologic Type, Digestive System Neoplasms, Carcinoma, Liver Neoplasms, Neoplasms, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-869Drug

    Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity

  • SorafenibDrug

    Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.

Study groups in NCT01009593
Study groupRoleWhat they receive
ABT-869ExperimentalNot described
Receives: Drug: ABT-869
SorafenibActive comparatorNot described
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: From randomization until patient death; assessed monthly

Secondary outcomes (2)

  1. Time To Progression (TTP)

    Measured: From randomization until patient progression; assessed every 6 weeks

  2. Overall Response Rate (ORR)

    Measured: Assessed Every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2012
  4. Study completionJul 2012

Why it stopped: See termination reason in detailed description

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,035 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009593
Sponsor's protocol ID
M10-963
Other IDs
2009-013435-38, 2009
Status last verified
Jun 2012
First submitted
14 Oct 2009
Last updated
10 Sep 2012
Results posted
No

Publications

  • 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.

    PubMed 34052255

  • 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.

    PubMed 25488963

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-869 and Sorafenib in people with Hepatocellular Carcinoma Non-resectable and Hepatocellular Carcinoma Recurrent, run by Abbott at 163 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in Japan, China, United States, South Korea, Taiwan and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: See termination reason in detailed description). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From randomization until patient death; assessed monthly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009593, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.

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