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

NCT01009593 | Terminated Phase 3

• 2 other identifiers: M10-9632009-013435-38
• Study Type: interventional
• Target: 1,035
• Locations: 28 countries
• Sites: 159

Brief 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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From randomization until patient death; assessed monthly

Secondary Outcomes (2)

• Time To Progression (TTP)

  From randomization until patient progression; assessed every 6 weeks

• Overall Response Rate (ORR)

  Assessed Every 6 weeks

Study Arms (2)

ABT-869

EXPERIMENTAL

Drug: ABT-869

Sorafenib

ACTIVE COMPARATOR

Drug: Sorafenib

Interventions

ABT-869 DRUG

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

ABT-869

Sorafenib DRUG

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

Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (163)

Site Reference ID/Investigator# 23247

Beverly Hills, California, 90211-1850, United States

Location

Site Reference ID/Investigator# 23608

LaVerne, California, 91750, United States

Location

Site Reference ID/Investigator# 23852

Orange, California, 92868, United States

Location

Site Reference ID/Investigator# 40162

Orange, California, 92868, United States

Location

Site Reference ID/Investigator# 23254

Newark, Delaware, 19713, United States

Location

Site Reference ID/Investigator# 23253

Gainesville, Georgia, 30505, United States

Location

Site Reference ID/Investigator# 23609

Honolulu, Hawaii, 96813, United States

Location

Site Reference ID/Investigator# 24848

Honolulu, Hawaii, 96819, United States

Location

Site Reference ID/Investigator# 23250

Louisville, Kentucky, 40202, United States

Location

Site Reference ID/Investigator# 23257

St Louis, Missouri, 63104, United States

Location

Site Reference ID/Investigator# 23603

Las Vegas, Nevada, 89135, United States

Location

Site Reference ID/Investigator# 23244

Durham, North Carolina, 27710, United States

Location

Site Reference ID/Investigator# 23252

Portland, Oregon, 97213, United States

Location

Site Reference ID/Investigator# 35705

Buenos Aires, B1629ODT, Argentina

Location

Site Reference ID/Investigator# 35702

Rosario, Santa Fe, S2002KDS, Argentina

Location

Site Reference ID/Investigator# 23152

Camperdown, 2050, Australia

Location

Site Reference ID/Investigator# 23150

Concord, 2139, Australia

Location

Site Reference ID/Investigator# 27122

Kingswood, 2747, Australia

Location

Site Reference ID/Investigator# 23153

Kogarah, 2217, Australia

Location

Site Reference ID/Investigator# 24103

Southport, 4215, Australia

Location

Site Reference ID/Investigator# 27968

Graz, 8036, Austria

Location

Site Reference ID/Investigator# 27969

Innsbruck, A-6020, Austria

Location

Site Reference ID/Investigator# 27970

Linz, 4020, Austria

Location

Site Reference ID/Investigator# 27967

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 38902

Brussels, 1070, Belgium

Location

Site Reference ID/Investigator# 23162

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator# 23843

Edegem, 2650, Belgium

Location

Site Reference ID/Investigator# 23161

Ghent, 9000, Belgium

Location

Site Reference ID/Investigator# 23842

Gilly, 6060, Belgium

Location

Site Reference ID/Investigator# 23163

Leuven, 3000, Belgium

Location

Site Reference ID/Investigator# 26702

Edmonton, T6G 2X8, Canada

Location

Site Reference ID/Investigator# 25482

Halifax, B3H 2Y9, Canada

Location

Site Reference ID/Investigator# 39614

Montreal, H2X 3J4, Canada

Location

Site Reference ID/Investigator# 23184

Ottawa, K1H 8L6, Canada

Location

Site Reference ID/Investigator# 23183

Sherbrooke, J1G 2E8, Canada

Location

Site Reference ID/Investigator# 24522

Toronto, M4C 3E7, Canada

Location

Site Reference ID/Investigator# 36967

Temuco, 01745, Chile

Location

Site Reference ID/Investigator# 36964

Viña del Mar, Chile

Location

Site Reference ID/Investigator# 23186

Beijing, 100071, China

Location

Site Reference ID/Investigator# 43443

Changchun, 130012, China

Location

Site Reference ID/Investigator# 23194

Chengdu, 610041, China

Location

Site Reference ID/Investigator# 43442

Chongqing, 400038, China

Location

Site Reference ID/Investigator# 44444

Dalian, 116011, China

Location

Site Reference ID/Investigator# 43444

Fuzhou, 350025, China

Location

Site Reference ID/Investigator# 43482

Guangzhou, 510515, China

Location

Site Reference ID/Investigator# 42563

Hangzhou, 310016, China

Location

Site Reference ID/Investigator# 44443

Harbin, 150081, China

Location

Site Reference ID/Investigator# 44062

Jinan, 250031, China

Location

Site Reference ID/Investigator# 23191

Nanjing, 210002, China

Location

Site Reference ID/Investigator# 44063

Nanning, 530021, China

Location

Site Reference ID/Investigator# 42817

Qingdao, 266003, China

Location

Site Reference ID/Investigator# 40624

Shanghai, 200032, China

Location

Site Reference ID/Investigator# 23189

Shanghai, 200080, China

Location

Site Reference ID/Investigator# 40448

Suzhou, 215006, China

Location

Site Reference ID/Investigator# 23190

Xi'an, 710032, China

Location

Site Reference ID/Investigator# 23167

Brno, 625 00, Czechia

Location

Site Reference ID/Investigator# 23166

Olomouc, 775 20, Czechia

Location

Site Reference ID/Investigator# 24523

Prague, 12808, Czechia

Location

Site Reference ID/Investigator# 23844

Prague, 14021, Czechia

Location

Site Reference ID/Investigator# 40930

Prague, 18081, Czechia

Location

Site Reference ID/Investigator# 23197

Ústí nad Labem, 401 13, Czechia

Location

Site Reference ID/Investigator# 23442

Aarhus C, 8000, Denmark

Location

Site Reference ID/Investigator# 23198

Alexandria, 21131, Egypt

Location

Site Reference ID/Investigator# 23199

Cairo, 11796, Egypt

Location

Site Reference ID/Investigator# 43302

Amiens, 80054, France

Location

Site Reference ID/Investigator# 23201

Clichy, 92118, France

Location

Site Reference ID/Investigator# 43144

Créteil, 94010, France

Location

Site Reference ID/Investigator# 23200

Lille, 59037, France

Location

Site Reference ID/Investigator# 23168

Paris, 75571, France

Location

Site Reference ID/Investigator# 40623

Paris, 75651, France

Location

Site Reference ID/Investigator# 28345

Rouen, 76031, France

Location

Site Reference ID/Investigator# 23165

Strasbourg, 67091, France

Location

Site Reference ID/Investigator# 28347

Vandœuvre-lès-Nancy, 54511, France

Location

Site Reference ID/Investigator# 23267

Berlin, 13353, Germany

Location

Site Reference ID/Investigator# 23845

Bochum, 44789, Germany

Location

Site Reference ID/Investigator# 23266

Frankfurt am Main, 60590, Germany

Location

Site Reference ID/Investigator# 23268

Freiburg im Breisgau, 79106, Germany

Location

Site Reference ID/Investigator# 23269

Mainz, 55131, Germany

Location

Site Reference ID/Investigator# 24525

Athens, 115 27, Greece

Location

Site Reference ID/Investigator# 24980

Hong Kong, Hong Kong

Location

Site Reference ID/Investigator# 27998

Benevento, 82100, Italy

Location

Site Reference ID/Investigator# 23424

Milan, 20122, Italy

Location

Site Reference ID/Investigator# 41488

Milan, 20132, Italy

Location

Site Reference ID/Investigator# 23425

Palermo, 90127, Italy

Location

Site Reference ID/Investigator# 41542

Pavia, 27100, Italy

Location

Site Reference ID/Investigator# 23428

Rome, 00144, Italy

Location

Site Reference ID/Investigator# 24042

Rome, 00168, Italy

Location

Site Reference ID/Investigator# 26506

Aichi, Japan

Location

Site Reference ID/Investigator# 36308

Chiba, Japan

Location

Site Reference ID/Investigator# 37602

Chiba, Japan

Location

Site Reference ID/Investigator# 29758

Fukuoka, Japan

Location

Site Reference ID/Investigator# 37603

Hokkaido, Japan

Location

Site Reference ID/Investigator# 28189

Ibaraki-ken, Japan

Location

Site Reference ID/Investigator# 26505

Kanazawa, Japan

Location

Site Reference ID/Investigator# 29757

Kumamoto, Japan

Location

Site Reference ID/Investigator# 27343

Kurume, Japan

Location

Site Reference ID/Investigator# 29759

Matsuyama, Japan

Location

Site Reference ID/Investigator# 26507

Osaka, Japan

Location

Site Reference ID/Investigator# 27959

Osaka, Japan

Location

Site Reference ID/Investigator# 26508

Sayama, Japan

Location

Site Reference ID/Investigator# 29756

Shimotsuke, Japan

Location

Site Reference ID/Investigator# 36782

Shizuoka, Japan

Location

Site Reference ID/Investigator# 28187

Tochigi-ken, Japan

Location

Site Reference ID/Investigator# 26503

Tokyo, Japan

Location

Site Reference ID/Investigator# 27242

Tokyo, Japan

Location

Site Reference ID/Investigator# 26504

Yokohama, Japan

Location

Site Reference ID/Investigator# 26509

Yufu, Japan

Location

Site Reference ID/Investigator# 23461

George Town, 11200, Malaysia

Location

Site Reference ID/Investigator# 23460

Kuala Lumpur, 50603, Malaysia

Location

Site Reference ID/Investigator# 23459

Petaling Jaya, Selangor, 46050, Malaysia

Location

Site Reference ID/Investigator# 23155

Durango, DGO., CP 34000, Mexico

Location

Site Reference ID/Investigator# 43102

Monterrey, NL, CP 64000, Mexico

Location

Site Reference ID/Investigator# 43145

Monterrey, NL, CP 64020, Mexico

Location

Site Reference ID/Investigator# 23272

Amsterdam, 1081 HV, Netherlands

Location

Site Reference ID/Investigator# 23270

Amsterdam, 1105 AZ, Netherlands

Location

Site Reference ID/Investigator# 24782

Rotterdam, 3015 CE, Netherlands

Location

Site Reference ID/Investigator# 23160

Auckland, 1142, New Zealand

Location

Site Reference ID/Investigator# 23846

Oslo, 0407, Norway

Location

Site Reference ID/Investigator# 42706

Ponce, 00716, Puerto Rico

Location

Site Reference ID/Investigator# 42705

San Juan, 00936-5067, Puerto Rico

Location

Site Reference ID/Investigator# 33979

Baia Mare, 430031, Romania

Location

Site Reference ID/Investigator# 33344

Bucharest, 022328, Romania

Location

Site Reference ID/Investigator# 33343

Cluj-Napoca, 400015, Romania

Location

Site Reference ID/Investigator# 33977

Craiova, 200385, Romania

Location

Site Reference ID/Investigator# 33345

Iași, 700106, Romania

Location

Site Reference ID/Investigator# 33346

Oradea, 410469, Romania

Location

Site Reference ID/Investigator# 43202

Chelyabinsk, 454087, Russia

Location

Site Reference ID/Investigator# 43203

Kazan', 420029, Russia

Location

Site Reference ID/Investigator# 23462

Moscow, 115478, Russia

Location

Site Reference ID/Investigator# 23849

Moscow, 115478, Russia

Location

Site Reference ID/Investigator# 23159

Singapore, 119228, Singapore

Location

Site Reference ID/Investigator# 23158

Singapore, 169610, Singapore

Location

Site Reference ID/Investigator# 23447

Busan, 602-715, South Korea

Location

Site Reference ID/Investigator# 39003

Busan, 614-735, South Korea

Location

Site Reference ID/Investigator# 23445

Busan, 626-770, South Korea

Location

Site Reference ID/Investigator# 23444

Daegu, 700-721, South Korea

Location

Site Reference ID/Investigator# 26543

Gyeonggi-do, 410-769, South Korea

Location

Site Reference ID/Investigator# 23457

Jeollanam-do, 519-809, South Korea

Location

Site Reference ID/Investigator# 39002

Jeonju, 561-712, South Korea

Location

Site Reference ID/Investigator# 23454

Seoul, 120-752, South Korea

Location

Site Reference ID/Investigator# 25562

Seoul, 138-701, South Korea

Location

Site Reference ID/Investigator# 23449

Seoul, 138-736, South Korea

Location

Site Reference ID/Investigator# 23456

Seoul, 152-703, South Korea

Location

Site Reference ID/Investigator# 23450

Suwon, 443-721, South Korea

Location

Site Reference ID/Investigator# 23466

A Coruña, 15006, Spain

Location

Site Reference ID/Investigator# 26063

Madrid, 28007, Spain

Location

Site Reference ID/Investigator# 40931

Madrid, 28033, Spain

Location

Site Reference ID/Investigator# 23465

Madrid, 28034, Spain

Location

Site Reference ID/Investigator# 23463

Madrid, 28050, Spain

Location

Site Reference ID/Investigator# 23467

Santander, 39008, Spain

Location

Site Reference ID/Investigator# 23468

Zaragoza, 50009, Spain

Location

Site Reference ID/Investigator# 23475

Changhua, 500, Taiwan

Location

Site Reference ID/Investigator# 23472

Kaohsiung County, 833, Taiwan

Location

Site Reference ID/Investigator# 25262

Taichung, 404, Taiwan

Location

Site Reference ID/Investigator# 23474

Taichung, 40705, Taiwan

Location

Site Reference ID/Investigator# 23476

Tainan, 704, Taiwan

Location

Site Reference ID/Investigator# 23478

Tainan, 710, Taiwan

Location

Site Reference ID/Investigator# 23477

Tainan, 736, Taiwan

Location

Site Reference ID/Investigator# 23470

Taipei, 10449, Taiwan

Location

Site Reference ID/Investigator# 43237

Taipei, 110, Taiwan

Location

Site Reference ID/Investigator# 23473

Taipei, 112, Taiwan

Location

Site Reference ID/Investigator# 23469

Taipei, Taiwan

Location

Site Reference ID/Investigator# 23471

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 34052255 DERIVED

• 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.

  PMID: 25488963 DERIVED

MeSH Terms

Conditions

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

Interventions

linifanib; Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Justin Ricker, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: November 6, 2009
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 10, 2012

Record last verified: 2012-06

Locations

CZ (6); EG (2); AU (5); BE (6); US (13); FR (9); DE (5); JP (20); TW (12); ES (7); NL (3); CN (17); RO (6); NZ (1); HK (1); GR (1); CL (2); IT (7); MY (3); RU (4); AR (2); CA (6); ME (3); NO (1); SG (2); KR (12); PR (2); DK (1)