Clinical Trial Details

EORTC-1410-BTG

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INTELLANCE 2: ABT 414 alone or ABT 414 plus temozolomide versus lomustine or temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain Tumor Group

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 14-Jan-2015
Date Step1 close: 04-Jul-2016
Date Step2 close: 13-Jul-2016
Data management at EORTC Yes
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 240 - All Groups: 240
Treatment Drug
Temozolomide, Lomustine, ABT-414
Study Staff Martin J. van den Bent (Study Coordinator) , Erasmus MC , Rotterdam
Edith Bastiaens (Data Manager) , EORTC Headquarters, Brussels
Katrien Baus (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Peter De Burghgraeve (Data Manager) , EORTC Headquarters, Brussels
Vassilis Golfinopoulos (Clinical Research Physician) , EORTC Headquarters, Brussels
Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels
Marie Morfouace (Clinical Scientist) , EORTC Headquarters, Brussels
Sarah Nuyens (Project Manager) , EORTC Headquarters, Brussels
Nabila Sebti (Data Manager) , EORTC Headquarters, Brussels
Maarten Spruyt (Data Manager) , EORTC Headquarters, Brussels
Type of cancer Brain
Participating groups EORTC Brain Tumor Group
Recruiting centers A.Z. St. Jan (Brugge, Belgium)
AUSL Bologna - Ospedale Bellaria (Bologna, Italy)
Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - Hopital Avicenne (Bobigny, France)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
CHRU de Lille (Lille, France)
CHU Lyon - Hopital neurologique Pierre Wertheimer (Bron, France)
CHU de Nice - Hopital Pasteur (Nice, France)
Calvary Mater Newcastle (Waratah, Australia)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Chang Gung Memorial Hospital Linkou Medical Center (Taoyuan, Taiwan)
China Medical University Hospital (Taichung, Taiwan)
Cleveland Clinic Foundation (Cleveland, United States of America)
Clinica Universitaria De Navarra (Pamplona, Spain)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Columbia University Medical Center (New York, United States of America)
Cork University Hospital (Cork, Ireland)
Erasmus MC (Rotterdam, Netherlands)
Fakultní nemocnice Ostrava (Ostrava-Poruba, Czech Republic)
Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium)
Gustave Roussy (Villejuif, France)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
Helsinki University Central Hospital - Dept of Oncology (Helsinki, Finland)
Hopital de La Timone (APHM) (Marseille, France)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Zambrano Hellion (San Pedro Garza García, Mexico)
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital (Cottingham, United Kingdom)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
IRCCS - Istituto Neurologico Carlo Besta (Milano, Italy)
IRCCS - Istituto Oncologico Veneto (Padova, Italy)
Institut de Cancerologie de l’Ouest (ICO) - Angers (Angers, France)
Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Nantes - St. Herblain, France)
Kepler University Hospital (Linz, Austria)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
Masaryk Memorial Cancer Institute (Brno, Czech Republic)
Medical University Of Gdansk (Gdansk, Poland)
Medical University Of Lodz - Institute Of Oncology (Lodz, Poland)
Montreal Neurological Institute and Hospital McGill University (Montreal, Canada)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
National Cancer Centre (Singapore, Singapore)
National Institute Of Neurosurgery (Budapest, Hungary)
National Institute Of Oncology (Budapest, Hungary)
National Taiwan University Hospital (Taipei, Taiwan)
National University Hospital (Singapore, Singapore)
Ospedale Generale Regionale (Bolzano, Italy)
Pecsi Tudomanyegyetem Onkoterapias Intezet (Pecs, Hungary)
Port Macquarie Base Hospital (Port Macquarie, Australia)
Royal Adelaide Hospital (Adelaide, Australia)
Royal Brisbane And Women's Hospital (Herston - Brisbane, Australia)
Royal Hobart Hospital (Hobart, Australia)
Royal North Shore Hospital (St Leonards, Australia)
Rush University Medical Center (Chicago, United States of America)
SCRI HealthONE (Denver, United States of America)
SLRON location Beaumont Hospital (Dublin, Ireland)
Samsung Medical Center (Seoul, Korea (Republic of))
Sarah Cannon Research Institute (Nashville, United States of America)
Seoul National University Bundang Hospital (Gyeonggi-do, Korea (Republic of))
Seoul National University Hospital (Seoul, Korea (Republic of))
Southern Medical Day Care Centre (Wollongong, Australia)
Swedish Neuroscience Institute (Seattle, United States of America)
Taichung Veterans General Hospital (Taichung, Taiwan)
Taipei Veterans General Hospital (Taipei, Taiwan)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Geelong Hospital - Andrew Love Cancer Centre (Geelong, Australia)
The Long Island Brain Tumor Center at Neurological Surgery P.C. (Lake Success, United States of America)
Turku University Central Hospital (Turku, Finland)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom)
UKE - University Cancer Center (Hamburg, Germany)
UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinikum Regensburg (Regensburg, Germany)
Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
University College Hospital (London, United Kingdom)
University Hospital Hradec Kralove (Hradec Kralove, Czech Republic)
University Hospital Motol (Prague, Czech Republic)
University Hospital St. Poelten (St. Poelten, Austria)
University Medical Center Groningen (Groningen, Netherlands)
University Of Pittsburgh Cancer Institute (Pittsburgh, United States of America)
University of Colorado (Aurora, United States of America)
University of Debrecen Medical Health Care Center (Debrecen, Hungary)
University of Texas Southwestern Medical Center (Dallas, United States of America)
ZNA Middelheim (Antwerpen, Belgium)
Protocol summary http://clinicaltrials.gov/ct/show/NCT02343406
NCT number NCT02343406
EudraCT 2014-004438-24
Financial Support Fully supported