Spots Global Cancer Trial Database for Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas
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Trial Identification
Brief Title: Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas
Official Title: INTELLANCE-2: ABT-414 Alone or ABT-414 Plus Temozolomide Versus Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase 2 Study of the EORTC Brain Tumor Group
Study ID: NCT02343406
Conditions
Study Description
Brief Summary: This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.
Detailed Description: The study objectives were to assess whether depatuxizumab mafodotin (ABT-414) alone or in combination with temozolomide (TMZ) improved overall survival (OS), progression-free survival (PFS), tumor response, quality of life, neurological deterioration-free survival (NDFS), and steroid use compared to standard treatment with lomustine single agent or TMZ re-challenge in adult subjects ≥ 18 years of age with centrally-confirmed recurrent epidermal growth factor receptor (EGFR)-amplified glioblastoma. The safety, pharmacokinetics, and efficacy of depatuxizumab mafodotin in children \<18 years of age was evaluated in a pediatric substudy. The EMEA-001732-PIP02-15 pediatric investigation plan was withdrawn on 07 July 2019 due to the discontinuation of the depatuxizumab mafodotin research program.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Lucile Packard Children's Hosp /ID# 153678, Palo Alto, California, United States
Children's Hospital Colorado /ID# 153677, Aurora, Colorado, United States
Univ of Colorado Cancer Center /ID# 134882, Aurora, Colorado, United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 141798, Denver, Colorado, United States
Rush University Medical Center /ID# 137542, Chicago, Illinois, United States
Dana-Farber Cancer Institute /ID# 154210, Boston, Massachusetts, United States
Long Island Brain Tumor Center /ID# 134496, Lake Success, New York, United States
Weill Cornell Medicine /ID# 152656, New York, New York, United States
Cleveland Clinic Main Campus /ID# 137540, Cleveland, Ohio, United States
University of Pittsburgh MC /ID# 134491, Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC /ID# 134492, Nashville, Tennessee, United States
UT Southwestern Medical Center /ID# 136718, Dallas, Texas, United States
Swedish Medical Center /ID# 136719, Seattle, Washington, United States
Port Macquarie Base Hospital /ID# 134569, Port Macquarie, New South Wales, Australia
Sydney Children's Hospital /ID# 153533, Randwick, New South Wales, Australia
Royal North Shore Hospital /ID# 147092, Saint Leonards, New South Wales, Australia
Calvary Mater Newcastle /ID# 134570, Waratah, New South Wales, Australia
Southern Medical Day Care Ctr /ID# 134495, Wollongong, New South Wales, Australia
Royal Brisbane and Women's Hospital /ID# 147091, Herston, Queensland, Australia
Royal Adelaide Hospital /ID# 135208, Adelaide, South Australia, Australia
Royal Hobart Hospital /ID# 135209, Hobart, Tasmania, Australia
Barwon Health University Hospital Geelong /ID# 134493, Geelong, Victoria, Australia
Royal Children's Hospital /ID# 157624, Melbourne, Victoria, Australia
University Hospital St. Polten /ID# 139070, St. Pölten, Niederoesterreich, Austria
LKH-Univ. Klinikum Graz /ID# 139071, Graz, , Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 139068, Linz, , Austria
Cliniques Universitaires Saint Luc /ID# 139391, Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Grand Hôpital de Charleroi /ID# 139342, Charleroi, Hainaut, Belgium
UZ Gent /ID# 152944, Gent, Oost-Vlaanderen, Belgium
AZ St-Jan Brugge-Oostende AV /ID# 137927, Brugge, West-Vlaanderen, Belgium
ZNA Middelheim /ID# 137926, Antwerp, , Belgium
UZ Leuven /ID# 137925, Leuven, , Belgium
Montreal Neurological Institut /ID# 136309, Montreal, Quebec, Canada
Fakultni Nemocnice v Motole /ID# 139509, Prague 5, Praha 5, Czechia
Masarykuv onkologikcy ustav /ID# 139508, Brno, , Czechia
FN Hradec Kralove /ID# 139510, Hradec Kralove, , Czechia
Univ Hosp Ostrava-Poruba /ID# 139507, Ostrava, , Czechia
Helsinki Univ Central Hospital /ID# 140078, Helsinki, , Finland
Helsinki Univ Central Hospital /ID# 153069, Helsinki, , Finland
Turku University Hospital /ID# 140861, Turku, , Finland
CHRU Lille - Hôpital Claude Huriez /ID# 137916, Lille CEDEX, Hauts-de-France, France
Centre Oscar Lambret /ID# 169619, Lille, Hauts-de-France, France
CHU-Hopital Avicenne /ID# 137910, Bobigny, Ile-de-France, France
Gustave Roussy /ID# 137912, Villejuif, Ile-de-France, France
Institut de Cancer de l'Ouest /ID# 137914, St Herblain CEDEX, Loire-Atlantique, France
Hopital de la Timone /ID# 137911, Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France
CHU de Nice /ID# 137917, Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France
Centre Leon Berard /ID# 137918, Lyon CEDEX 08, Rhone, France
Institut de Cancer de l'Ouest /ID# 137909, Angers, , France
Hospices Civils de Lyon /ID# 137913, Bron, , France
Hopital Pitie Salpetriere /ID# 145887, Paris, , France
Universitaetsklinik Heidelberg /ID# 137924, Heidelberg, Baden-Wuerttemberg, Germany
Universitatsklinik Regensburg /ID# 137920, Ratisbon, Bayern, Germany
Univ Klinik Eppendorf Hamburg /ID# 137921, Hamburg, , Germany
LMU Klinikum der Universität München /ID# 137922, Munich, , Germany
Universitatsklinikum Tubingen /ID# 137923, Tuebingen, , Germany
Pecsi Tudomanyegyetem /ID# 136111, Pécs, Pecs, Hungary
Semmelweis Egyetem /ID# 152578, Budapest, , Hungary
National Institute of Oncology /ID# 135970, Budapest, , Hungary
Orszagos Klinikai Idegtudomany /ID# 135971, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ /ID# 135969, Debrecen, , Hungary
Cork University Hospital /ID# 136828, Cork, , Ireland
Beaumont Hospital /ID# 136829, Dublin, , Ireland
Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 138335, Bologna, , Italy
Ospedale Generale di Bolzano /ID# 138338, Bolzano, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 140395, Milan, , Italy
Istituto Oncologico Veneto /ID# 138336, Padova, , Italy
Azienda Ospedaliera Sant' Andrea /ID# 138337, Rome, , Italy
Seoul National Univ Bundang ho /ID# 136841, Seongnam, Gyeonggido, Korea, Republic of
Samsung Medical Center /ID# 136842, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 136840, Seoul, , Korea, Republic of
Hospital Zambrano Hellion /ID# 138076, San Pedro Garza García, , Mexico
Vrije Universiteit Medisch Centrum /ID# 137221, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen /ID# 138266, Groningen, , Netherlands
Erasmus Medisch Centrum /ID# 136981, Rotterdam, , Netherlands
Haaglanden Medisch Centrum /ID# 137222, The Hague, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 137219, Utrecht, , Netherlands
Prinses Maxima Centrum /ID# 204409, Utrecht, , Netherlands
Uniwersyteckie Centrum Kliniczne /ID# 137919, Gdansk, Mazowieckie, Poland
Wojewodzkie Wielospecjalistycz /ID# 137654, Lodz, , Poland
National University Hospital /ID# 135951, Singapore, , Singapore
National Cancer Ctr Singapore /ID# 135952, Singapore, , Singapore
KK Women's & Children Hospital /ID# 153676, Singapore, , Singapore
Instituto Catalán de Oncología (ICO) Badalona /ID# 140976, Badalona, Barcelona, Spain
Clinica Universitar de Navarra - Pamplona /ID# 140047, Pamplona, Navarra, Comunidad, Spain
Instituto Catalan de Oncologia (ICO) & Hosp. de Bellvitge /ID# 137688, Barcelona, , Spain
Hospital Universitario Nino /ID# 153800, Madrid, , Spain
Hosp Univ 12 de Octubre /ID# 137908, Madrid, , Spain
Centre Hospitalier Univ Vaudoi /ID# 137929, Lausanne, , Switzerland
University Hospital Zurich /ID# 137930, Zurich, , Switzerland
China Medical University Hosp /ID# 136976, Taichung City, Taichung, Taiwan
National Taiwan Univ Hosp /ID# 136975, Taipei City, Taipei, Taiwan
Taichung Veterans General Hosp /ID# 136977, Taichung City, , Taiwan
Taipei Veterans General Hosp /ID# 136974, Taipei City, , Taiwan
Linkou Chang Gung Memorial Ho /ID# 136944, Taoyuan City, , Taiwan
Guy's and St Thomas' NHS Found /ID# 140312, London, London, City Of, United Kingdom
Univ Hospitals Birmingham NHS Foundation trust /ID# 136978, Birmingham, , United Kingdom
Gartnavel General Hospital /ID# 136979, Glasgow, , United Kingdom
Hull and East Yorkshire NHS /ID# 136917, Hull, , United Kingdom
University College Hospitals /ID# 136879, London, , United Kingdom
Great Ormond St Hospital NHS /ID# 153421, London, , United Kingdom
Christie NHS Foundation Trust /ID# 140313, Manchester, , United Kingdom
Contact Details
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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