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

NCT ID: NCT01009593

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1035 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-07-31

Brief Summary

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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

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

Conditions

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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

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-869

Group Type EXPERIMENTAL

ABT-869

Intervention Type DRUG

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

Sorafenib

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

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

Interventions

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ABT-869

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

Intervention Type DRUG

Sorafenib

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Ricker, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 23247

Beverly Hills, California, United States

Site Status

Site Reference ID/Investigator# 23608

LaVerne, California, United States

Site Status

Site Reference ID/Investigator# 23852

Orange, California, United States

Site Status

Site Reference ID/Investigator# 40162

Orange, California, United States

Site Status

Site Reference ID/Investigator# 23254

Newark, Delaware, United States

Site Status

Site Reference ID/Investigator# 23253

Gainesville, Georgia, United States

Site Status

Site Reference ID/Investigator# 23609

Honolulu, Hawaii, United States

Site Status

Site Reference ID/Investigator# 24848

Honolulu, Hawaii, United States

Site Status

Site Reference ID/Investigator# 23250

Louisville, Kentucky, United States

Site Status

Site Reference ID/Investigator# 23257

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 23603

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 23244

Durham, North Carolina, United States

Site Status

Site Reference ID/Investigator# 23252

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 35705

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 35702

Rosario, Santa Fe, , Argentina

Site Status

Site Reference ID/Investigator# 23152

Camperdown, , Australia

Site Status

Site Reference ID/Investigator# 23150

Concord, , Australia

Site Status

Site Reference ID/Investigator# 27122

Kingswood, , Australia

Site Status

Site Reference ID/Investigator# 23153

Kogarah, , Australia

Site Status

Site Reference ID/Investigator# 24103

Southport, , Australia

Site Status

Site Reference ID/Investigator# 27968

Graz, , Austria

Site Status

Site Reference ID/Investigator# 27969

Innsbruck, , Austria

Site Status

Site Reference ID/Investigator# 27970

Linz, , Austria

Site Status

Site Reference ID/Investigator# 27967

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 38902

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 23162

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 23843

Edegem, , Belgium

Site Status

Site Reference ID/Investigator# 23161

Ghent, , Belgium

Site Status

Site Reference ID/Investigator# 23842

Gilly, , Belgium

Site Status

Site Reference ID/Investigator# 23163

Leuven, , Belgium

Site Status

Site Reference ID/Investigator# 26702

Edmonton, , Canada

Site Status

Site Reference ID/Investigator# 25482

Halifax, , Canada

Site Status

Site Reference ID/Investigator# 39614

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 23184

Ottawa, , Canada

Site Status

Site Reference ID/Investigator# 23183

Sherbrooke, , Canada

Site Status

Site Reference ID/Investigator# 24522

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 36967

Temuco, , Chile

Site Status

Site Reference ID/Investigator# 36964

Viña del Mar, , Chile

Site Status

Site Reference ID/Investigator# 23186

Beijing, , China

Site Status

Site Reference ID/Investigator# 43443

Changchun, , China

Site Status

Site Reference ID/Investigator# 23194

Chengdu, , China

Site Status

Site Reference ID/Investigator# 43442

Chongqing, , China

Site Status

Site Reference ID/Investigator# 44444

Dalian, , China

Site Status

Site Reference ID/Investigator# 43444

Fuzhou, , China

Site Status

Site Reference ID/Investigator# 43482

Guangzhou, , China

Site Status

Site Reference ID/Investigator# 42563

Hangzhou, , China

Site Status

Site Reference ID/Investigator# 44443

Harbin, , China

Site Status

Site Reference ID/Investigator# 44062

Jinan, , China

Site Status

Site Reference ID/Investigator# 23191

Nanjing, , China

Site Status

Site Reference ID/Investigator# 44063

Nanning, , China

Site Status

Site Reference ID/Investigator# 42817

Qingdao, , China

Site Status

Site Reference ID/Investigator# 40624

Shanghai, , China

Site Status

Site Reference ID/Investigator# 23189

Shanghai, , China

Site Status

Site Reference ID/Investigator# 40448

Suzhou, , China

Site Status

Site Reference ID/Investigator# 23190

Xi'an, , China

Site Status

Site Reference ID/Investigator# 23167

Brno, , Czechia

Site Status

Site Reference ID/Investigator# 23166

Olomouc, , Czechia

Site Status

Site Reference ID/Investigator# 24523

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 23844

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 40930

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 23197

Ústí nad Labem, , Czechia

Site Status

Site Reference ID/Investigator# 23442

Aarhus C, , Denmark

Site Status

Site Reference ID/Investigator# 23198

Alexandria, , Egypt

Site Status

Site Reference ID/Investigator# 23199

Cairo, , Egypt

Site Status

Site Reference ID/Investigator# 43302

Amiens, , France

Site Status

Site Reference ID/Investigator# 23201

Clichy, , France

Site Status

Site Reference ID/Investigator# 43144

Créteil, , France

Site Status

Site Reference ID/Investigator# 23200

Lille, , France

Site Status

Site Reference ID/Investigator# 23168

Paris, , France

Site Status

Site Reference ID/Investigator# 40623

Paris, , France

Site Status

Site Reference ID/Investigator# 28345

Rouen, , France

Site Status

Site Reference ID/Investigator# 23165

Strasbourg, , France

Site Status

Site Reference ID/Investigator# 28347

Vandœuvre-lès-Nancy, , France

Site Status

Site Reference ID/Investigator# 23267

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 23845

Bochum, , Germany

Site Status

Site Reference ID/Investigator# 23266

Frankfurt am Main, , Germany

Site Status

Site Reference ID/Investigator# 23268

Freiburg im Breisgau, , Germany

Site Status

Site Reference ID/Investigator# 23269

Mainz, , Germany

Site Status

Site Reference ID/Investigator# 24525

Athens, , Greece

Site Status

Site Reference ID/Investigator# 24980

Hong Kong, , Hong Kong

Site Status

Site Reference ID/Investigator# 27998

Benevento, , Italy

Site Status

Site Reference ID/Investigator# 23424

Milan, , Italy

Site Status

Site Reference ID/Investigator# 41488

Milan, , Italy

Site Status

Site Reference ID/Investigator# 23425

Palermo, , Italy

Site Status

Site Reference ID/Investigator# 41542

Pavia, , Italy

Site Status

Site Reference ID/Investigator# 23428

Rome, , Italy

Site Status

Site Reference ID/Investigator# 24042

Rome, , Italy

Site Status

Site Reference ID/Investigator# 26506

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 36308

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 37602

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 29758

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 37603

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 28189

Ibaraki-ken, , Japan

Site Status

Site Reference ID/Investigator# 26505

Kanazawa, , Japan

Site Status

Site Reference ID/Investigator# 29757

Kumamoto, , Japan

Site Status

Site Reference ID/Investigator# 27343

Kurume, , Japan

Site Status

Site Reference ID/Investigator# 29759

Matsuyama, , Japan

Site Status

Site Reference ID/Investigator# 26507

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 27959

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 26508

Sayama, , Japan

Site Status

Site Reference ID/Investigator# 29756

Shimotsuke, , Japan

Site Status

Site Reference ID/Investigator# 36782

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 28187

Tochigi-ken, , Japan

Site Status

Site Reference ID/Investigator# 26503

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 27242

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 26504

Yokohama, , Japan

Site Status

Site Reference ID/Investigator# 26509

Yufu, , Japan

Site Status

Site Reference ID/Investigator# 23461

George Town, , Malaysia

Site Status

Site Reference ID/Investigator# 23460

Kuala Lumpur, , Malaysia

Site Status

Site Reference ID/Investigator# 23459

Petaling Jaya, Selangor, , Malaysia

Site Status

Site Reference ID/Investigator# 23155

Durango, DGO., , Mexico

Site Status

Site Reference ID/Investigator# 43102

Monterrey, NL, , Mexico

Site Status

Site Reference ID/Investigator# 43145

Monterrey, NL, , Mexico

Site Status

Site Reference ID/Investigator# 23272

Amsterdam, , Netherlands

Site Status

Site Reference ID/Investigator# 23270

Amsterdam, , Netherlands

Site Status

Site Reference ID/Investigator# 24782

Rotterdam, , Netherlands

Site Status

Site Reference ID/Investigator# 23160

Auckland, , New Zealand

Site Status

Site Reference ID/Investigator# 23846

Oslo, , Norway

Site Status

Site Reference ID/Investigator# 42706

Ponce, , Puerto Rico

Site Status

Site Reference ID/Investigator# 42705

San Juan, , Puerto Rico

Site Status

Site Reference ID/Investigator# 33979

Baia Mare, , Romania

Site Status

Site Reference ID/Investigator# 33344

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 33343

Cluj-Napoca, , Romania

Site Status

Site Reference ID/Investigator# 33977

Craiova, , Romania

Site Status

Site Reference ID/Investigator# 33345

Iași, , Romania

Site Status

Site Reference ID/Investigator# 33346

Oradea, , Romania

Site Status

Site Reference ID/Investigator# 43202

Chelyabinsk, , Russia

Site Status

Site Reference ID/Investigator# 43203

Kazan', , Russia

Site Status

Site Reference ID/Investigator# 23462

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 23849

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 23159

Singapore, , Singapore

Site Status

Site Reference ID/Investigator# 23158

Singapore, , Singapore

Site Status

Site Reference ID/Investigator# 23447

Busan, , South Korea

Site Status

Site Reference ID/Investigator# 39003

Busan, , South Korea

Site Status

Site Reference ID/Investigator# 23445

Busan, , South Korea

Site Status

Site Reference ID/Investigator# 23444

Daegu, , South Korea

Site Status

Site Reference ID/Investigator# 26543

Gyeonggi-do, , South Korea

Site Status

Site Reference ID/Investigator# 23457

Jeollanam-do, , South Korea

Site Status

Site Reference ID/Investigator# 39002

Jeonju, , South Korea

Site Status

Site Reference ID/Investigator# 23454

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 25562

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 23449

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 23456

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 23450

Suwon, , South Korea

Site Status

Site Reference ID/Investigator# 23466

A Coruña, , Spain

Site Status

Site Reference ID/Investigator# 26063

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 40931

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 23465

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 23463

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 23467

Santander, , Spain

Site Status

Site Reference ID/Investigator# 23468

Zaragoza, , Spain

Site Status

Site Reference ID/Investigator# 23475

Changhua, , Taiwan

Site Status

Site Reference ID/Investigator# 23472

Kaohsiung County, , Taiwan

Site Status

Site Reference ID/Investigator# 25262

Taichung, , Taiwan

Site Status

Site Reference ID/Investigator# 23474

Taichung, , Taiwan

Site Status

Site Reference ID/Investigator# 23476

Tainan City, , Taiwan

Site Status

Site Reference ID/Investigator# 23478

Tainan City, , Taiwan

Site Status

Site Reference ID/Investigator# 23477

Tainan City, , Taiwan

Site Status

Site Reference ID/Investigator# 23470

Taipei, , Taiwan

Site Status

Site Reference ID/Investigator# 43237

Taipei, , Taiwan

Site Status

Site Reference ID/Investigator# 23473

Taipei, , Taiwan

Site Status

Site Reference ID/Investigator# 23469

Taipei, , Taiwan

Site Status

Site Reference ID/Investigator# 23471

Taoyuan District, , Taiwan

Site Status

Countries

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United States Argentina Australia Austria Belgium Canada Chile China Czechia Denmark Egypt France Germany Greece Hong Kong Italy Japan Malaysia Mexico Netherlands New Zealand Norway Puerto Rico Romania Russia Singapore South Korea Spain Taiwan

References

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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.

Reference Type DERIVED
PMID: 34052255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25488963 (View on PubMed)

Other Identifiers

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2009-013435-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-963

Identifier Type: -

Identifier Source: org_study_id