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

Phase 3

Terminated

• 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
• Interventions: Drug: ABT-869; Drug: Sorafenib

• Registration Number: NCT01009593
• Lead Sponsor: Abbott

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Study Start: 2010-01
• Status Verified: 2012-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1035

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-869	ABT-869	-
Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	From randomization until patient death; assessed monthly

Secondary Outcome Measures

Name	Time	Method
Time To Progression (TTP)	From randomization until patient progression; assessed every 6 weeks
Overall Response Rate (ORR)	Assessed Every 6 weeks

Trial Locations

Locations (163)

Site Reference ID/Investigator# 24848; 🇺🇸 Honolulu, Hawaii, United States

Site Reference ID/Investigator# 23609; 🇺🇸 Honolulu, Hawaii, United States

Site Reference ID/Investigator# 23250; 🇺🇸 Louisville, Kentucky, United States

Site Reference ID/Investigator# 23183; 🇨🇦 Sherbrooke, Canada

Site Reference ID/Investigator# 23253; 🇺🇸 Gainesville, Georgia, United States

Site Reference ID/Investigator# 23152; 🇦🇺 Camperdown, Australia

Site Reference ID/Investigator# 27122; 🇦🇺 Kingswood, Australia

Site Reference ID/Investigator# 40162; 🇺🇸 Orange, California, United States

Site Reference ID/Investigator# 23194; 🇨🇳 Chengdu, China

Site Reference ID/Investigator# 44062; 🇨🇳 Jinan, China

Site Reference ID/Investigator# 23191; 🇨🇳 Nanjing City, China

Site Reference ID/Investigator# 40448; 🇨🇳 Suzhou, China

Site Reference ID/Investigator# 25482; 🇨🇦 Halifax, Canada

Site Reference ID/Investigator# 23252; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 23153; 🇦🇺 Kogarah, Australia

Site Reference ID/Investigator# 23257; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 23244; 🇺🇸 Durham, North Carolina, United States

Site Reference ID/Investigator# 43442; 🇨🇳 Chongqing, China

Site Reference ID/Investigator# 44063; 🇨🇳 Nanning City, China

Site Reference ID/Investigator# 39614; 🇨🇦 Montreal, Canada

Site Reference ID/Investigator# 24103; 🇦🇺 Southport, Australia

Site Reference ID/Investigator# 23150; 🇦🇺 Concord, Australia

Site Reference ID/Investigator# 43443; 🇨🇳 Changchun, China

Site Reference ID/Investigator# 44444; 🇨🇳 Dalian, China

Site Reference ID/Investigator# 43482; 🇨🇳 Guangzhou City, China

Site Reference ID/Investigator# 41488; 🇮🇹 Milan, Italy

Site Reference ID/Investigator# 43144; 🇫🇷 Creteil, France

Site Reference ID/Investigator# 23266; 🇩🇪 Frankfurt am Main, Germany

Site Reference ID/Investigator# 43444; 🇨🇳 Fuzhou, China

Site Reference ID/Investigator# 42563; 🇨🇳 Hangzhou, China

Site Reference ID/Investigator# 44443; 🇨🇳 Harbin, China

Site Reference ID/Investigator# 40624; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 41542; 🇮🇹 Pavia, Italy

Site Reference ID/Investigator# 23428; 🇮🇹 Rome, Italy

Site Reference ID/Investigator# 24042; 🇮🇹 Rome, Italy

Site Reference ID/Investigator# 24522; 🇨🇦 Toronto, Canada

Site Reference ID/Investigator# 23199; 🇪🇬 Cairo, Egypt

Site Reference ID/Investigator# 23268; 🇩🇪 Freiburg, Germany

Site Reference ID/Investigator# 23160; 🇳🇿 Auckland, New Zealand

Site Reference ID/Investigator# 23467; 🇪🇸 Santander, Spain

Site Reference ID/Investigator# 36308; 🇯🇵 Chiba, Japan

Site Reference ID/Investigator# 23424; 🇮🇹 Milan, Italy

Site Reference ID/Investigator# 23200; 🇫🇷 Lille Cedex, France

Site Reference ID/Investigator# 27998; 🇮🇹 Benevento, Italy

Site Reference ID/Investigator# 23201; 🇫🇷 Clichy, France

Site Reference ID/Investigator# 40623; 🇫🇷 Paris Cedex 13, France

Site Reference ID/Investigator# 23466; 🇪🇸 A Coruna, Spain

Site Reference ID/Investigator# 26063; 🇪🇸 Madrid, Spain

Site Reference ID/Investigator# 23158; 🇸🇬 Singapore, Singapore

Site Reference ID/Investigator# 23468; 🇪🇸 Zaragoza, Spain

Site Reference ID/Investigator# 23442; 🇩🇰 Aarhus C, Denmark

Site Reference ID/Investigator# 23425; 🇮🇹 Palermo, Italy

Site Reference ID/Investigator# 23477; 🇨🇳 Tainan, Taiwan

Site Reference ID/Investigator# 23470; 🇨🇳 Taipei City, Taiwan

Site Reference ID/Investigator# 23473; 🇨🇳 Taipei, Taiwan

Site Reference ID/Investigator# 23608; 🇺🇸 LaVerne, California, United States

Site Reference ID/Investigator# 23852; 🇺🇸 Orange, California, United States

Site Reference ID/Investigator# 23247; 🇺🇸 Beverly Hills, California, United States

Site Reference ID/Investigator# 23842; 🇧🇪 Gilly, Belgium

Site Reference ID/Investigator# 26702; 🇨🇦 Edmonton, Canada

Site Reference ID/Investigator# 23184; 🇨🇦 Ottawa, Canada

Site Reference ID/Investigator# 36967; 🇨🇱 Temuco, Chile

Site Reference ID/Investigator# 23186; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 36964; 🇨🇱 Vina del Mar, Chile

Site Reference ID/Investigator# 42817; 🇨🇳 Qingdao, China

Site Reference ID/Investigator# 23190; 🇨🇳 Xian, China

Site Reference ID/Investigator# 24523; 🇨🇿 Prague 2, Czech Republic

Site Reference ID/Investigator# 23189; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 23168; 🇫🇷 Paris Cedex 12, France

Site Reference ID/Investigator# 43302; 🇫🇷 Amiens, France

Site Reference ID/Investigator# 28345; 🇫🇷 Rouen Cedex, France

Site Reference ID/Investigator# 28347; 🇫🇷 Vandoeuvre Les Nancy, France

Site Reference ID/Investigator# 23267; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 23165; 🇫🇷 Strasbourg Cedex, France

Site Reference ID/Investigator# 24525; 🇬🇷 Athens, Greece

Site Reference ID/Investigator# 23845; 🇩🇪 Bochum, Germany

Site Reference ID/Investigator# 23269; 🇩🇪 Mainz, Germany

Site Reference ID/Investigator# 37602; 🇯🇵 Chiba, Japan

Site Reference ID/Investigator# 29758; 🇯🇵 Fukuoka, 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# 26508; 🇯🇵 Osakasayama, Japan

Site Reference ID/Investigator# 29759; 🇯🇵 Matsuyama-city, 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# 26509; 🇯🇵 Yufu, Japan

Site Reference ID/Investigator# 23447; 🇰🇷 Busan, Korea, Republic of

Site Reference ID/Investigator# 39003; 🇰🇷 Busan, Korea, Republic of

Site Reference ID/Investigator# 23444; 🇰🇷 Daegu, Korea, Republic of

Site Reference ID/Investigator# 23445; 🇰🇷 Busan, Korea, Republic of

Site Reference ID/Investigator# 25562; 🇰🇷 Seoul, Korea, Republic of

Site Reference ID/Investigator# 26543; 🇰🇷 Gyeonggi-do, Korea, Republic of

Site Reference ID/Investigator# 23457; 🇰🇷 Jeollanam-do, Korea, Republic of

Site Reference ID/Investigator# 23454; 🇰🇷 Seoul, Korea, Republic of

Site Reference ID/Investigator# 39002; 🇰🇷 Jeonju-si, Korea, Republic of

Site Reference ID/Investigator# 23449; 🇰🇷 Seoul, Korea, Republic of

Site Reference ID/Investigator# 23456; 🇰🇷 Seoul, Korea, Republic of

Site Reference ID/Investigator# 23450; 🇰🇷 Suwon-si, Korea, Republic of

Site Reference ID/Investigator# 43102; 🇲🇽 Monterrey, NL, Mexico

Site Reference ID/Investigator# 23270; 🇳🇱 Amsterdam, Netherlands

Site Reference ID/Investigator# 42705; 🇵🇷 San Juan, Puerto Rico

Site Reference ID/Investigator# 23272; 🇳🇱 Amsterdam, Netherlands

Site Reference ID/Investigator# 23846; 🇳🇴 Oslo, Norway

Site Reference ID/Investigator# 23462; 🇷🇺 Moscow, Russian Federation

Site Reference ID/Investigator# 23465; 🇪🇸 Madrid, Spain

Site Reference ID/Investigator# 23159; 🇸🇬 Singapore, Singapore

Site Reference ID/Investigator# 40931; 🇪🇸 Madrid, Spain

Site Reference ID/Investigator# 23474; 🇨🇳 Taichung, Taiwan

Site Reference ID/Investigator# 23463; 🇪🇸 Madrid, Spain

Site Reference ID/Investigator# 25262; 🇨🇳 Taichung City, Taiwan

Site Reference ID/Investigator# 23476; 🇨🇳 Tainan, Taiwan

Site Reference ID/Investigator# 23471; 🇨🇳 Taoyuan, Taiwan

Site Reference ID/Investigator# 43145; 🇲🇽 Monterrey, NL, Mexico

Site Reference ID/Investigator# 28189; 🇯🇵 Ibaraki-ken, Japan

Site Reference ID/Investigator# 43202; 🇷🇺 Chelyabinsk, Russian Federation

Site Reference ID/Investigator# 35705; 🇦🇷 Buenos Aires, Argentina

Site Reference ID/Investigator# 23844; 🇨🇿 Prague 4, Czech Republic

Site Reference ID/Investigator# 27970; 🇦🇹 Linz, Austria

Site Reference ID/Investigator# 23603; 🇺🇸 Las Vegas, Nevada, United States

Site Reference ID/Investigator# 35702; 🇦🇷 Rosario, Santa Fe, Argentina

Site Reference ID/Investigator# 27969; 🇦🇹 Innsbruck, Austria

Site Reference ID/Investigator# 38902; 🇧🇪 Brussels, Belgium

Site Reference ID/Investigator# 23162; 🇧🇪 Brussels, Belgium

Site Reference ID/Investigator# 23843; 🇧🇪 Edegem, Belgium

Site Reference ID/Investigator# 23161; 🇧🇪 Ghent, Belgium

Site Reference ID/Investigator# 23163; 🇧🇪 Leuven, Belgium

Site Reference ID/Investigator# 23166; 🇨🇿 Olomouc, Czech Republic

Site Reference ID/Investigator# 23198; 🇪🇬 Alexandria, Egypt

Site Reference ID/Investigator# 23254; 🇺🇸 Newark, Delaware, United States

Site Reference ID/Investigator# 27968; 🇦🇹 Graz, Austria

Site Reference ID/Investigator# 27967; 🇦🇹 Vienna, Austria

Site Reference ID/Investigator# 40930; 🇨🇿 Prague 8, Czech Republic

Site Reference ID/Investigator# 23197; 🇨🇿 Usti nad Labem, Czech Republic

Site Reference ID/Investigator# 37603; 🇯🇵 Hokkaido, Japan

Site Reference ID/Investigator# 27959; 🇯🇵 Osaka, Japan

Site Reference ID/Investigator# 42706; 🇵🇷 Ponce, Puerto Rico

Site Reference ID/Investigator# 33344; 🇷🇴 Bucharest, Romania

Site Reference ID/Investigator# 33343; 🇷🇴 Cluj Napoca, Romania

Site Reference ID/Investigator# 33345; 🇷🇴 Iasi, Romania

Site Reference ID/Investigator# 23472; 🇨🇳 Kaohsiung County, Taiwan

Site Reference ID/Investigator# 23849; 🇷🇺 Moscow, Russian Federation

Site Reference ID/Investigator# 23167; 🇨🇿 Brno, Czech Republic

Site Reference ID/Investigator# 26506; 🇯🇵 Aichi, Japan

Site Reference ID/Investigator# 26504; 🇯🇵 Yokohama City, Japan

Site Reference ID/Investigator# 23155; 🇲🇽 Durango, DGO., Mexico

Site Reference ID/Investigator# 33979; 🇷🇴 Baia Mare, Romania

Site Reference ID/Investigator# 26507; 🇯🇵 Osaka, Japan

Site Reference ID/Investigator# 29756; 🇯🇵 Shimotsuke, Japan

Site Reference ID/Investigator# 27242; 🇯🇵 Tokyo, Japan

Site Reference ID/Investigator# 23461; 🇲🇾 Penang, Malaysia

Site Reference ID/Investigator# 23459; 🇲🇾 Petaling Jaya, Selangor, Malaysia

Site Reference ID/Investigator# 24782; 🇳🇱 Rotterdam, Netherlands

Site Reference ID/Investigator# 33977; 🇷🇴 Craiova, Romania

Site Reference ID/Investigator# 33346; 🇷🇴 Oradea, Romania

Site Reference ID/Investigator# 43203; 🇷🇺 Kazan, Russian Federation

Site Reference ID/Investigator# 23475; 🇨🇳 Changhua City, Taiwan

Site Reference ID/Investigator# 23469; 🇨🇳 Taipei, Taiwan

Site Reference ID/Investigator# 23460; 🇲🇾 Kuala Lumpur, Malaysia

Site Reference ID/Investigator# 23478; 🇨🇳 Tainan, Taiwan

Site Reference ID/Investigator# 43237; 🇨🇳 Taipei, Taiwan

Site Reference ID/Investigator# 24980; 🇭🇰 Hong Kong, Hong Kong