Last updated on August 2018

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 (INTELLANCE 2)


Brief description of study

This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide versus temozolomide or lomustine alone in participants with recurrent glioblastoma multiforme.

The study includes a Pediatric sub-study to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.

Adult enrollment has been completed and the study is now only recruiting for pediatric participants.

Detailed Study Description

The pediatric sub-study is an uncontrolled, open-label, single-arm global study. This sub-study is to evaluate the safety, tolerability, and pharmacokinetics of ABT-414 in a pediatric population less than 18 years of age as well as to assess the effect of ABT-414 on tumor response per Response Assessment in Neuro-Oncology (RANO) criteria.

Clinical Study Identifier: NCT02343406

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Lucile Packard Children's Hosp /ID# 153678
Palo Alto, CA United States
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Univ of Colorado Cancer Center /ID# 134882
Aurora, CO United States
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Univ of Colorado Cancer Center /ID# 153677
Aurora, CO United States
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Rush University Medical Center /ID# 137542
Chicago, IL United States
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Dana-Farber Cancer Institute /ID# 154210
Boston, MA United States
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Cleveland Clinic Foundation /ID# 137540
Cleveland, OH United States
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University of Pittsburgh MC /ID# 134491
Pittsburgh, PA United States
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Tennessee Oncology, PLLC /ID# 134492
Nashville, TN United States
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Tennessee Oncology-Sarah Cannon Research Institute /ID# 141798
Nashville, TN United States
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UT Southwestern Medical Center /ID# 136718
Dallas, TX United States
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Swedish Medical Center /ID# 136719
Seattle, WA United States
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Port Macquarie Base Hospital /ID# 134569
Port Macquarie, Australia
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Sydney Children's Hospital /ID# 153533
Randwick, Australia
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Royal North Shore Hospital /ID# 147092
Saint Leonards, Australia
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Calvary Mater Newcastle /ID# 134570
Waratah, Australia
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Southern Medical Day Care Ctr /ID# 134495
Wollongong, Australia
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Royal Brisbane and Women's Hospital /ID# 147091
Herston, Australia
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Adelaide, Australia
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Hobart, Australia
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Barwon Health, Univ Hosp Geelo /ID# 134493
Geelong, Australia
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Royal Children's Hospital /ID# 157624
Melbourne, Australia
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University Hospital St. Polten /ID# 139070
St. Pölten, Austria
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Graz, Austria
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Kepler Universitatskliniken /ID# 139068
Linz, Austria
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Cliniques Universitaires Saint Luc /ID# 139391
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Leuven, Belgium
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Hospital for Sick Children /ID# 202506
Toronto, ON Canada
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Montreal Neurological Institut /ID# 136309
Montreal, QC Canada
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Masarykuv onkologikcy ustav /ID# 139508
Brno, Czechia
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FN Hradec Kralove /ID# 139510
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Univ Hosp Ostrava-Poruba /ID# 139507
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Helsinki, Finland
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Helsinki, Finland
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Turku University Hospital /ID# 140861
Turku, Finland
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CHRU Lille - H pital Claude Huriez /ID# 137916
Lille CEDEX, France
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Centre Oscar Lambret /ID# 169619
Lille, France
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Institut Gustave Roussy /ID# 137912
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Institut de Cancer de l'Ouest /ID# 137914
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Pécs, Hungary
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National Institute of Oncology /ID# 135970
Budapest, Hungary
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Debrecen, Hungary
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Cork, Ireland
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