Spots Global Cancer Trial Database for Nintedanib (BIBF 1120) in Mesothelioma
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Trial Identification
Brief Title: Nintedanib (BIBF 1120) in Mesothelioma
Official Title: LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma
Study ID: NCT01907100
Conditions
Study Description
Brief Summary: This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of California San Francisco, San Francisco, California, United States
Rocky Mountain Cancer Centers, Littleton, Colorado, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Greenville Health System, Greenville, South Carolina, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology - McAllen, McAllen, Texas, United States
Texas Oncology-San Antonio Northeast, San Antonio, Texas, United States
Cancer Care Northwest Centers, PS, Spokane Valley, Washington, United States
Sanatorio Güemes, Ciudad Autónoma de Bs As, , Argentina
Instituto Medico Especializado Alexander Fleming, Ciudad Autónoma de Bs As, , Argentina
Clínica Universitaria Reina Fabiola, Ciudad de Cordoba, , Argentina
Northern Cancer Institute, St Leonards, New South Wales, Australia
Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia
The Prince Charles Hospital, Chermside, Queensland, Australia
Mater Cancer Care Centre, South Brisbane, Queensland, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Peninsula Haematology & Oncology, Frankston, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Border Onclogy Research, Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Perth Oncology, Perth, Western Australia, Australia
LKH Leoben, Leoben, , Austria
AKH - Medical University of Vienna, Vienna, , Austria
Klinikum Wels - Grieskirchen GmbH, Wels, , Austria
Brussels - UNIV Saint-Luc, Bruxelles, , Belgium
Edegem - UNIV UZ Antwerpen, Edegem, , Belgium
UNIV UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
AZ Sint-Maarten, Mechelen, , Belgium
QEII Health Sciences Centre (Dalhousie University), Halifax, Nova Scotia, Canada
Health Sciences North, Sudbury, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
IUCPQ (Laval University), Quebec, , Canada
Centro Internacional de Estudios Clínicos - CIEC, Recoleta, , Chile
Orlandi Oncologia, Vitacura, , Chile
University Clinic for Pulmonary Diseases, Zagreb, , Croatia
University Hospital Brno, Brno, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
Rigshospitalet, København, Onkologisk afdeling, Købenahvn Ø, , Denmark
Clinical Research Center Alexandria, Alexandria, , Egypt
Medical Research Institute, Alexandria, , Egypt
National Cancer Institute, Cairo University, Cairo, , Egypt
Nasser Institute, Cairo, , Egypt
CLI Bordeaux Nord Aquitaine, Bordeaux, , France
HOP Morvan, Brest, , France
HOP Côte de Nacre, Caen, , France
HOP Calmette, Lille, , France
HOP Nord, Marseille, , France
HOP Lyon Sud, Pierre-Bénite, , France
HOP HIA Saint-Anne, Toulon, , France
HOP Larrey, Toulouse, , France
INS Gustave Roussy, Villejuif, , France
Vivantes Netzwerk für Gesundheit GmbH, Berlin, , Germany
Helios Klinikum Emil von Behring, Berlin, , Germany
Klinik Schillerhöhe GmbH, Gerlingen, , Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH, Großhansdorf, , Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum des Saarlandes, Homburg/Saar, , Germany
Klinik, Löwenstein, Löwenstein, , Germany
Rambam Medical Center, Haifa, , Israel
Rabin Medical Center Beilinson, Petach Tikva, , Israel
Sourasky Medical Center, Tel-Aviv, , Israel
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy
Centro di riferimento Oncologico, Aviano (PN), , Italy
Humanitas Gavazzeni, Bergamo, , Italy
Istituto Nazionale per la Ricerca sul Cancro, Genova, , Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga, Orbassano (TO), , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena, , Italy
University Hospital of Occupational and Environmental Health, Fukuoka, Kitakyushu, , Japan
Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Amagasaki, , Japan
Hyogo College of Medicine Hospital, Hyogo, Nishinomiya, , Japan
Yokosuka Kyosai Hospital, Kanagawa , Yokosuka, , Japan
Japan Labour Health and Safety Organization Okayama Rosai Hospital, Okayama, Okayama, , Japan
Kindai University Hospital, Osaka, OsakaSayama, , Japan
Otemae Hospital, Osaka, Osaka, , Japan
Juntendo University Hospital, Tokyo, Bunkyo-ku, , Japan
Centro Oncologico de Chihuahua, Chihuahua, , Mexico
Instituto Nacional de Cancerologia, Mexico, , Mexico
Centro Oncologico Estatal ISSEMYM, Toluca, , Mexico
Medisch Spectrum Twente, Enschede, , Netherlands
Zuyderland Medisch Centrum, Heerlen, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet, Oslo, , Norway
St. Olavs Hospital, Universitetssykehuset i Trondheim, Trondheim, , Norway
University Clinical Center, Gdansk, Gdansk, , Poland
Clin.Hosp.Med.Univ.Marcinkowski in Poznan, Poznan, , Poland
Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland, Poznan, , Poland
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie, Warsaw, , Poland
Centro Hospitalar Lisboa Norte Hospital Pulido Valente, Lisboa, , Portugal
Hospital CUF Porto, Porto, , Portugal
St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med", Chelyabinsk, , Russian Federation
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan", Kazan, , Russian Federation
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF, Moscow, , Russian Federation
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst., Saint-Petersburg, , Russian Federation
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF, Saint-Petersburg, , Russian Federation
SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan, Ufa, , Russian Federation
Wilgers Oncology Centre, Pretoria, , South Africa
Hospital Universitario de Cruces, Barakaldo (Vizcaya), , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Universitario Donostia, Donostia (Gipuzkoa), , Spain
Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Hospital Virgen del Rocío, Sevilla, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Sahlgrenska US, Göteborg, Göteborg, , Sweden
Universitetssjukhuset, Linköping, Linköping, , Sweden
Skånes universitetssjukhus, Lund, Lund, , Sweden
Karolinska Univ. sjukhuset, Stockholm, , Sweden
Akademiska sjukhuset, Uppsala, , Sweden
Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has., Eskisehir, , Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Istanbul, , Turkey
Dr.Suat Seren EAH, Izmir, , Turkey
Western General Hospital, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Guy's Hospital, London, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Wythenshawe Hospital, Wythenshawe, , United Kingdom
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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