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Brief Title: A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
Official Title: A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma
Study ID: NCT01761266
Brief Summary: E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Facility # 1, Los Angeles, California, United States
Facility # 1, Sacramento, California, United States
Facility # 1, San Francisco, California, United States
Facility # 1, Washington, District of Columbia, United States
Facility # 1, Tampa, Florida, United States
Facility # 1, Duluth, Georgia, United States
Facility # 1, Lawrenceville, Georgia, United States
Facility # 1, Baltimore, Maryland, United States
Facility # 1, Detroit, Michigan, United States
Facility # 1, Kansas City, Missouri, United States
Facility # 1, Saint Louis, Missouri, United States
Facility # 1, East Orange, New Jersey, United States
Facility # 1, Brooklyn, New York, United States
Facility # 1, Lake Success, New York, United States
Facility # 1, New York, New York, United States
Facility # 1, Charlotte, North Carolina, United States
Facility # 1, Durham, North Carolina, United States
Facility # 1, Portland, Oregon, United States
Facility # 1, Austin, Texas, United States
Facility # 1, Lubbock, Texas, United States
Facility # 1, Seattle, Washington, United States
Facility # 1, Camperdown, New South Wales, Australia
Facility # 1, Wentworthville, New South Wales, Australia
Facility # 1, Woolloongabba, Queensland, Australia
Facility # 1, Fitzroy, Victoria, Australia
Facility # 1, Melbourne, Victoria, Australia
Facility # 2, Melbourne, Victoria, Australia
Facility # 1, Nedlands, Western Australia, Australia
Facility # 1, Bruxelles, , Belgium
Facility # 1, Edegem, , Belgium
Facility # 1, Liege, , Belgium
Facility # 1, Ottawa, Ontario, Canada
Facility # 1, Hefei, Anhui, China
Facility # 1, Beijing, Beijing, China
Facility # 2, Beijing, Beijing, China
Facility # 3, Beijing, Beijing, China
Facility # 1, Chongqing, Chongqing, China
Facility # 1, Fuzhou, Fujian, China
Facility # 2, Fuzhou, Fujian, China
Facility # 1, Guangzhou, Guangdong, China
Facility # 1, Harbin, Heilongjiang, China
Facility # 1, Changsha, Hunan, China
Facility # 1, Nanjing, Jiangsu, China
Facility # 1, Suzhou, Jiangsu, China
Facility # 1, Changchun, Jilin, China
Facility # 1, Dalian, Liaoning, China
Facility # 1, Jinan, Shandong, China
Facility # 1, Shanghai, Shanghai, China
Facility # 3, Shanghai, Shanghai, China
Facility # 1, Xi'an, Shanxi, China
Facility # 2, Xi'an, Shanxi, China
Facility # 1, Hangzhou, Zhejiang, China
Facility # 1, Tianjin, Zhejiang, China
Facility # 1, Nice Cedex 3, Alpes Maritimes, France
Facility # 1, Pessac Cedex, Gironde, France
Facility # 1, Pessac, Gironde, France
Facility # 1, Toulouse, Haute Garonne, France
Facility # 1, Montpellier cedex 5, Herault, France
Facility # 1, Rennes cedex, Ille Et Vilaine, France
Facility # 1, Vandoeuvre les Nancy, Meurthe Et Moselle, France
Facility # 1, Amiens cedex 1, Somme, France
Facility # 1, Creteil Cedex, Val De Marne, France
Facility # 1, Bordeaux, , France
Facility # 1, Lille cedex, , France
Facility # 1, Lyon, , France
Facility # 1, Nord, , France
Facility # 1, Paris cedex 12, , France
Facility # 1, Paris, , France
Facility # 1, Rhone, , France
Facility # 1, Heidelberg, Baden Wuerttemberg, Germany
Facility # 1, Tuebingen, Baden Wuerttemberg, Germany
Facility # 1, Marburg, Hessen, Germany
Facility # 1, Hannover, Niedersachsen, Germany
Facility # 1, Essen, Nordrhein Westfalen, Germany
Facility # 1, Koeln, Nordrhein Westfalen, Germany
Facility # 1, Mainz, Rheinland Pfalz, Germany
Facility # 1, Hong Kong, , Hong Kong
Facility # 2, Hong Kong, , Hong Kong
Facility # 3, Hong Kong, , Hong Kong
Facility # 1, Kowloon, , Hong Kong
Facility # 1, Petach Tikva, , Israel
Facility # 1, Petah Tiqwa, , Israel
Facility # 1, Torrette, Ancona, Italy
Facility # 1, Bari, , Italy
Facility # 1, Benevento, , Italy
Facility # 1, Bologna, , Italy
Facility # 1, Napoli, , Italy
Facility # 2, Napoli, , Italy
Facility # 1, Palermo, , Italy
Facility # 1, Roma, , Italy
Facility # 1, Nagoya, Aichi, Japan
Facility # 1, Kashiwa, Chiba, Japan
Facility # 1, Matsuyama, Ehime, Japan
Facility # 1, Kurume, Fukuoka, Japan
Facility # 1, Sapporo, Hokkaido, Japan
Facility # 2, Sapporo, Hokkaido, Japan
Facility # 1, Nishinomiya, Hyogo, Japan
Facility # 1, Kanazawa, Ishikawa, Japan
Facility # 1, Kawasaki, Kanagawa, Japan
Facility # 1, Yokohama, Kanagawa, Japan
Facility # 1, Tsu, Mie, Japan
Facility # 1, Omura, Nagasaki, Japan
Facility # 1, Osaka-Sayama, Osaka, Japan
Facility # 1, Bunkyo-Ku, Tokyo, Japan
Facility # 1, Chuo-ku, Tokyo, Japan
Facility # 1, Koto-ku, Tokyo, Japan
Facility # 1, Minato-ku, Tokyo, Japan
Facility # 1, Musashino, Tokyo, Japan
Facility # 1, Shimonoseki, Yamaguchi, Japan
Facility # 1, Fukuoka, , Japan
Facility # 1, Hiroshima, , Japan
Facility # 1, Okayama, , Japan
Facility # 2, Osaka, , Japan
Facility # 1, Saga, , Japan
Facility # 2, Saga, , Japan
Facility # 1, Goyang-si, Gyeonggi-do, Korea, Republic of
Facility # 1, Seongnam-Si, Gyeonggi-do, Korea, Republic of
Facility # 2, Seongnam-Si, Gyeonggi-do, Korea, Republic of
Facility # 1, Suwon, Gyeonggi-do, Korea, Republic of
Facility # 1, Daegu, Gyeongsangbuk-do, Korea, Republic of
Facility # 1, Hwasun, Jeollanam-do, Korea, Republic of
Facility # 1, Busan, , Korea, Republic of
Facility # 2, Busan, , Korea, Republic of
Facility # 3, Busan, , Korea, Republic of
Facility # 1, Incheon, , Korea, Republic of
Facility # 1, Seoul, , Korea, Republic of
Facility # 2, Seoul, , Korea, Republic of
Facility # 3, Seoul, , Korea, Republic of
Facility # 4, Seoul, , Korea, Republic of
Facility # 5, Seoul, , Korea, Republic of
Facility # 6, Seoul, , Korea, Republic of
Facility # 7, Seoul, , Korea, Republic of
Facility # 8, Seoul, , Korea, Republic of
Facility # 1, Kuantan, Pahang, Malaysia
Facility # 1, Penang, Pulau Pinang, Malaysia
Facility # 1, Miri, Sarawak, Malaysia
Facility # 1, Batu Caves, Selangor, Malaysia
Facility # 1, Kuala Lumpur, , Malaysia
Facility # 1, Cebu City, , Philippines
Facility # 2, Cebu City, , Philippines
Facility # 1, Davao City, , Philippines
Facility # 1, Quezon City, , Philippines
Facility # 2, Quezon City, , Philippines
Facility # 1, Gdansk, , Poland
Facility # 1, Warszawa, , Poland
Facility # 1, Wroclaw, , Poland
Facility # 1, Arkhangelsk, , Russian Federation
Facility # 1, Moscow, , Russian Federation
Facility # 2, Moscow, , Russian Federation
Facility # 3, Saint Petersburg, , Russian Federation
Facility # 4, Saint Petersburg, , Russian Federation
Facility # 1, Ufa, , Russian Federation
Facility # 1, Singapore, , Singapore
Facility # 2, Singapore, , Singapore
Facility # 3, Singapore, , Singapore
Facility # 4, Singapore, , Singapore
Facility # 1, L'Hospitalet de Llobregat, Barcelona, Spain
Facility # 1, Santander, Cantabria, Spain
Facility # 1, Badajoz, , Spain
Facility # 1, Girona, , Spain
Facility # 1, Madrid, , Spain
Facility # 2, Madrid, , Spain
Facility # 3, Madrid, , Spain
Facility # 4, Madrid, , Spain
Facility # 1, Kaohsiung, , Taiwan
Facility # 2, Kaohsiung, , Taiwan
Facility # 1, Taichung, , Taiwan
Facility # 2, Taichung, , Taiwan
Facility # 1, Tainan, , Taiwan
Facility # 2, Tainan, , Taiwan
Facility # 1, Taipei, , Taiwan
Facility # 2, Taipei, , Taiwan
Facility # 3, Taipei, , Taiwan
Facility # 4, Taipei, , Taiwan
Facility # 5, Taipei, , Taiwan
Facility # 1, Taoyuan City, , Taiwan
Facility # 1, Bangkoknoi, Bangkok, Thailand
Facility # 1, Pathum Wan, Bangkok, Thailand
Facility # 1, Ratchathewi, Bangkok, Thailand
Facility # 1, Muang, Chiang Mai, Thailand
Facility # 1, Muang, Chiang Rai, Thailand
Facility # 2, London, Greater London, United Kingdom
Facility # 1, London, Greater London, United Kingdom
Facility # 3, London, Greater London, United Kingdom
Facility # 1, Manchester, Greater Manchester, United Kingdom
Facility # 1, Liverpool, Merseyside, United Kingdom
Facility # 1, Glasgow, Strathclyde, United Kingdom
Facility # 1, Birmingham, West Midlands, United Kingdom