266
Participants
Start Date
February 17, 2015
Primary Completion Date
June 24, 2019
Study Completion Date
June 24, 2019
Depatuxizumab mafodotin
Adults: intravenous administration (1.25 mg/kg or 1.0 mg/kg body weight) over 30 to 40 minutes once every 2 weeks until one of the treatment withdrawal criteria was met. The dose was 1.25 mg/kg in the original protocol (Version 1) and Version 2, Amendment 1, and was lowered to 1.0 mg/kg in protocol Version 3, Amendment 2. Pediatric participants: Intravenous administration (1.0 mg/kg body weight for those who were 6 to 17 years old at the date of first dose, or 1.3 mg/kg for those who were 0 to 5 years old) over 30 to 40 minutes or as directed by the guidelines once every 2 weeks until one of the treatment withdrawal criteria was met, for a maximum of one year. If used in combination with temozolomide, depatuxizumab mafodotin was dosed on Day 1 and Day 15 of the TMZ cycle (assuming a standard regimen of 200 mg/m\^2/day for 5 days of each 28-day cycle; for other TMZ schedules, timing of the depatuxizumab mafodotin dosing schedule were to be discussed with the medical monitor).
Temozolomide
Capsules administered orally, 150 mg/m\^2 on Days 1-5 for the first 28-day cycle, with dose escalation to 200 mg/m\^2 in subsequent cycles in case of adequate tolerance until one of the treatment withdrawal criteria was met.
Lomustine
Capsules administered orally, 110 mg/m\^2 on Day 1 of every 42-day treatment period. Treatment continued until one of the treatment withdrawal criteria was met, for a maximum of one year.
Centre Hospitalier Univ Vaudoi /ID# 137929, Lausanne
Semmelweis Egyetem /ID# 152578, Budapest
National Institute of Oncology /ID# 135970, Budapest
Orszagos Klinikai Idegtudomany /ID# 135971, Budapest
Cliniques Universitaires Saint Luc /ID# 139391, Woluwe-Saint-Lambert
ZNA Middelheim /ID# 137926, Antwerp
Sydney Children's Hospital /ID# 153533, Randwick
Royal North Shore Hospital /ID# 147092, Saint Leonards
Calvary Mater Newcastle /ID# 134570, Waratah
Port Macquarie Base Hospital /ID# 134569, Port Macquarie
Southern Medical Day Care Ctr /ID# 134495, Wollongong
UZ Leuven /ID# 137925, Leuven
Royal Children's Hospital /ID# 157624, Melbourne
University Hospital St. Polten /ID# 139070, Sankt Pölten
Barwon Health University Hospital Geelong /ID# 134493, Geelong
Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 139068, Linz
Royal Brisbane and Women's Hospital /ID# 147091, Herston
Debreceni Egyetem Klinikai Központ /ID# 135969, Debrecen
Royal Adelaide Hospital /ID# 135208, Adelaide
Grand Hôpital de Charleroi /ID# 139342, Charleroi
Royal Hobart Hospital /ID# 135209, Hobart
Pecsi Tudomanyegyetem /ID# 136111, Pécs
AZ St-Jan Brugge-Oostende AV /ID# 137927, Bruges
LKH-Univ. Klinikum Graz /ID# 139071, Graz
University Hospital Zurich /ID# 137930, Zurich
UZ Gent /ID# 152944, Ghent
National Taiwan Univ Hosp /ID# 136975, Taipei City
Long Island Brain Tumor Center /ID# 134496, Lake Success
Taipei Veterans General Hosp /ID# 136974, Taipei
Hopital de la Timone /ID# 137911, Marseille
Seoul National Univ Bundang ho /ID# 136841, Seongnam
University of Pittsburgh MC /ID# 134491, Pittsburgh
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 140395, Milan
Univ Klinik Eppendorf Hamburg /ID# 137921, Hamburg
Turku University Hospital /ID# 140861, Turku
Hospital Universitario Nino /ID# 153800, Madrid
Hosp Univ 12 de Octubre /ID# 137908, Madrid
Clinica Universitar de Navarra - Pamplona /ID# 140047, Pamplona
Linkou Chang Gung Memorial Ho /ID# 136944, Taoyuan
Lucile Packard Children's Hosp /ID# 153678, Palo Alto
Istituto Oncologico Veneto /ID# 138336, Padua
Tennessee Oncology, PLLC /ID# 134492, Nashville
Ospedale Generale di Bolzano /ID# 138338, Bolzano
Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 138335, Bologna
China Medical University Hosp /ID# 136976, Taichung
Taichung Veterans General Hosp /ID# 136977, Taichung
Cleveland Clinic Main Campus /ID# 137540, Cleveland
Institut de Cancer de l'Ouest /ID# 137914, Saint-Herblain
Institut de Cancer de l'Ouest /ID# 137909, Angers
Centre Oscar Lambret /ID# 169619, Lille
CHRU Lille - Hôpital Claude Huriez /ID# 137916, Lille
Rush University Medical Center /ID# 137542, Chicago
Hospital Zambrano Hellion /ID# 138076, San Pedro Garza García
Universitaetsklinik Heidelberg /ID# 137924, Heidelberg
Centre Leon Berard /ID# 137918, Lyon
Hospices Civils de Lyon /ID# 137913, Bron
Universitatsklinikum Tubingen /ID# 137923, Tübingen
Hopital Pitie Salpetriere /ID# 145887, Paris
Children's Hospital Colorado /ID# 153677, Aurora
Univ of Colorado Cancer Center /ID# 134882, Aurora
Sarah Cannon Research Institute at HealthONE - Denver /ID# 141798, Denver
LMU Klinikum der Universität München /ID# 137922, Munich
CHU-Hopital Avicenne /ID# 137910, Bobigny
Universitatsklinik Regensburg /ID# 137920, Regensburg
Gustave Roussy /ID# 137912, Villejuif
Swedish Medical Center /ID# 136719, Seattle
National University Hospital /ID# 135951, Singapore
National Cancer Ctr Singapore /ID# 135952, Singapore
KK Women's & Children Hospital /ID# 153676, Singapore
Dana-Farber Cancer Institute /ID# 154210, Boston
Weill Cornell Medicine /ID# 152656, New York
UT Southwestern Medical Center /ID# 136718, Dallas
Montreal Neurological Institut /ID# 136309, Montreal
Fakultni Nemocnice v Motole /ID# 139509, Prague
Masarykuv onkologikcy ustav /ID# 139508, Brno
FN Hradec Kralove /ID# 139510, Hradec Králové
Univ Hosp Ostrava-Poruba /ID# 139507, Ostrava
Helsinki Univ Central Hospital /ID# 140078, Helsinki
Helsinki Univ Central Hospital /ID# 153069, Helsinki
CHU de Nice /ID# 137917, Nice
Cork University Hospital /ID# 136828, Cork
Beaumont Hospital /ID# 136829, Dublin
Azienda Ospedaliera Sant' Andrea /ID# 138337, Rome
Vrije Universiteit Medisch Centrum /ID# 137221, Amsterdam
Universitair Medisch Centrum Groningen /ID# 138266, Groningen
Erasmus Medisch Centrum /ID# 136981, Rotterdam
Haaglanden Medisch Centrum /ID# 137222, The Hague
Universitair Medisch Centrum Utrecht /ID# 137219, Utrecht
Prinses Maxima Centrum /ID# 204409, Utrecht
Uniwersyteckie Centrum Kliniczne /ID# 137919, Gdansk
Wojewodzkie Wielospecjalistycz /ID# 137654, Lodz
Samsung Medical Center /ID# 136842, Seoul
Seoul National University Hospital /ID# 136840, Seoul
Instituto Catalán de Oncología (ICO) Badalona /ID# 140976, Badalona
Instituto Catalan de Oncologia (ICO) & Hosp. de Bellvitge /ID# 137688, Barcelona
Guy's and St Thomas' NHS Found /ID# 140312, London
Univ Hospitals Birmingham NHS Foundation trust /ID# 136978, Birmingham
Gartnavel General Hospital /ID# 136979, Glasgow
Hull and East Yorkshire NHS /ID# 136917, Hull
University College Hospitals /ID# 136879, London
Great Ormond St Hospital NHS /ID# 153421, London
Christie NHS Foundation Trust /ID# 140313, Manchester
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
AbbVie
INDUSTRY