Spots Global Cancer Trial Database for A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments
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Trial Identification
Brief Title: A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) Versus BSC Alone in Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens
Study ID: NCT01529112
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the overall survival of patients receiving E7080 + Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.
Detailed Description: This double-blind, placebo-controlled, multicenter, randomized Phase II study will consist of a 2-arm design, comparing E7080 + BSC (Arm 1) with placebo + BSC (Arm 2). Participants will be randomized in the ratio of 2:1 to receive either E7080 or placebo in a blinded manner.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Donald W. Hill, M.D., F.A.C.P., Casa Grande, Arizona, United States
Arizona Oncology Associates , PC - HOPE, Tucson, Arizona, United States
Ronald Yanagihara, MD 9360 North Name Uno Suite 130 Gilroy California 95020, Gilroy, California, United States
Ocala Oncology Center, P.L., Ocala, Florida, United States
Washington University 660 South Euclid Avenue Campus Box 8124 St Louis Missouri 63110, Saint Louis, Missouri, United States
New York Oncology Heamatology - Latham, Clifton Park, New York, United States
Montefiore Medical Park 1695 Easchester Road Floor 1 Bronx, NY 10461, New York, New York, United States
Cancer Treatment and Research Centre Bismarck North Dakota 58501, Bismarck, North Dakota, United States
Texas Oncology, P.A. - Paris, Paris, Texas, United States
Texas Oncology, P.A. - Plano, Plano, Texas, United States
Texas Oncology, P.A. - Waco, Waco, Texas, United States
OLV Ziekenhuis, Aalst, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
AZ Sint-Maarten, Duffel, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Leuven, Leuven, , Belgium
C. H. R. de la Citadelle, Liege, , Belgium
Domaine Universitaire du Sart-Tilman, Liege, , Belgium
Institut onkologie a rehabilitace Na Plesi, Nova Ves pod Plesi, , Czechia
Avicennus, s.r.o., Nymburk, , Czechia
Fakultni nemocnice Na Bulovce, Praha 8, , Czechia
Oblastni nemocnice Pribram, a.s., Pribram, , Czechia
Semmelweis Egyetem AOK, Budapest, , Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, , Hungary
Matrai Gyogyintezet, Matrahaza, , Hungary
Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, , Hungary
Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza, Tatabanya, , Hungary
Tudogyogyintezet Torokbalint, Torokbalint, , Hungary
Zala Megyei Korhaz, Zalaegerszeg, , Hungary
Azienda Ospedaliera G. Rummo, Benevento, , Italy
Azienda Ospedaliero Universitaria San Martino, Genova, , Italy
Azienda Ospedaliera San Gerardo, Milano, , Italy
Istituto Clinico Humanitas, Milano, , Italy
Azienda Ospedaliera Universitaria di Parma, Parma, , Italy
Fondazione Salvatore Maugeri IRCCS, Pavia, , Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia, Perugia, , Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, , Italy
Ospedale Mater Salutis, Verona, , Italy
Chungbuk National University Hospital, Chungcheongbuk-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
The Catholic University of Korea Yeouido St. Mary's Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
Southampton General Hospital, Southampton, Hampshire, United Kingdom
North Staffs Royal Infirmary, Stoke-on-Trent, Staffordshire, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Strathclyde, United Kingdom
New Cross Hospital, Wolverhampton, West Midlands, United Kingdom
Contact Details
Name: Harish Dave
Affiliation: PharmaBio Development Inc.
Role: STUDY_DIRECTOR
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