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Summary

for people ages up to 99 years (full criteria)
at Palo Alto, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase II Study of the EORTC Brain Tumor Group (EORTC Protocol 1410-BTG) Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas

Details

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.

Keywords

Glioblastoma Multiforme European Organization for Research and Treatment of Cancer Brain Tumor Group Lomustine Pediatric High Grade Gliomas Pediatric diffuse Intrinsic Pontine Glioma Children Epithelial Growth Factor vIII mutation Antibody Drug Conjugate Temozolomide recurrent glioblastoma Epithelial Growth Factor ABT-414 EORTC Pediatric WHO grade III glioma EGFR amplification Pediatric WHO grade IV glioma Brain Tumor Glioblastoma Glioma Dacarbazine

Eligibility

You can join if…

Open to people ages up to 99 years

Adult participants (greater than or equal to 18 years old):

  • Histologically confirmed de novo (primary) Glioblastoma Multiforme with unequivocal tumor progression or recurrence.
  • In case of testing at the time of first progression: either at least 3 months after the end of radiotherapy or have tumor progression that is clearly outside the radiation field or have tumor progression unequivocally proven by surgery/biopsy
  • Absence of any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule; such conditions should be assessed with the patient before registration in the trial.
  • Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE]tumor) for central testing of Epithelial Growth Factor Receptor (EGFR) amplification
  • Presence of EGFR amplification confirmed by central assessment; participants with undetermined EGFR status are excluded
  • World Health Organization (WHO) Performance status 0 - 2
  • No more than one line of chemotherapy (concurrent and adjuvant Temozolomide based chemotherapy including in combination with another investigational agent is considered one line of chemotherapy). Chemotherapy must have been completed at least 4 weeks prior to randomization.
  • Post surgery MRI within 48 hours following surgery, however an MRI scan has to be done within 2 weeks prior to randomization.
  • Surgery completed at least 2 weeks before randomization and patients should have fully recovered as assessed by investigators.

Pediatric sub-study participants (less than 18 years old):

  • The study will only include patients under 3 years of age when results of a juvenile repeated mouse toxicity study become available and are favorable to support use in patients aged under 3 years.
  • Histologically proven high grade glioma (HGG: WHO grade III glioma [e.g anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma], grade IV glioma [e.g glioblastoma, gliosarcoma] or diffuse intrinsic pontine glioma [DIPG]).
  • Must either have recurrent/progressive tumor or, if newly diagnosed, have completed any planned radiation therapy at least 4 weeks prior to first dose of ABT-414.
  • The tumor tissue must have been determined to have EGFR amplification, (by local or other testing service).
  • availability of adequate biological material for retrospective confirmatory central testing of EGFR amplification
  • Participant has sufficiently recovered from previous therapy. The investigator believes that benefit of treating the pediatric subject with ABT-414 outweighs the expected risks and that this treatment is in the best interests of the pediatric subject.

You CAN'T join if...

Adult population (greater than or equal to 18 years old):

  • Prior treatment with nitrosoureas
  • Prior treatment with bevacizumab
  • Previous exposure to Epithelial Growth Factor Receptor (EGFR) targeted agents,including EGFRvIII targeting agents
  • Prior discontinuation of temozolomide chemotherapy for toxicity reasons
  • Prior Radiation Therapy (RT) with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven
  • Previous other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to randomization, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix
  • Women of childbearing potential must have a negative serum or urine pregnancy test(minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.
  • No history of wheat allergies and Coeliac disease.
  • No EIAED, patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). Patients previously on EIAED must be fully switched to non-EIAED at least 2 weeks prior to randomization.

Pediatric sub-study (less than 18 years old):

  • (For recurrent disease) No prior RT with a dose over 65Gy to the brain, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven
  • No current or recent (within 4 weeks or 5 half-lives (whichever is shorter) before enrollment) treatment with another investigational drug
  • Female participants of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.

Locations

  • Lucile Packard Children's Hospital /ID# 153678 not yet accepting patients
    Palo Alto, California, 94304, United States
  • Swedish Medical Center /ID# 136719 accepting new patients
    Seattle, Washington, 98122, United States
  • Sarah Cannon Research Institute at HealthONE /ID# 141798 accepting new patients
    Denver, Colorado, 80218, United States
  • Children's Hospital Colorado /ID# 153677 accepting new patients
    Aurora, Colorado, 80045, United States
  • University of Colorado Denver and the Health Sciences /ID# 134882 accepting new patients
    Aurora, Colorado, 80045, United States
  • UT Southwestern Medical Center /ID# 136718 accepting new patients
    Dallas, Texas, 75390-8852, United States
  • UT Southwestern Medical Center /ID# 167295 withdrawn
    Dallas, Texas, 75390-9032, United States
  • Hospital Zambrano Hellion /ID# 138076 accepting new patients
    Monterrey, N.L., C.P. 66278, Mexico
  • Rush University Medical Center /ID# 137542 accepting new patients
    Chicago, Illinois, 60612, United States
  • Tennessee Oncology, PLLC /ID# 134492 accepting new patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 141481 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 141482 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148451 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148452 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148453 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148454 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148455 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148485 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148486 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148487 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148488 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148489 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Tennessee Oncology, PLLC /ID# 148490 not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Cleveland Clinic Foundation /ID# 137540 accepting new patients
    Cleveland, Ohio, 44195, United States
  • University of Pittsburgh Cancer Institute /ID# 134491 accepting new patients
    Pittsburgh, Pennsylvania, 15232, United States
  • Montreal Neurological Institute and Hospital /ID# 136309 accepting new patients
    Montreal, H3A 2B4, Canada
  • Columbia University Medical Center /ID# 151165 accepting new patients
    New York, New York, 10032, United States
  • Columbia University Medical Center /ID# 152656 accepting new patients
    New York, New York, 10032, United States
  • The Long Island Brain Tumor Center /ID# 134496 withdrawn
    Lake Success, New York, 11042, United States
  • The Long Island Brain Tumor Center /ID# 134888 withdrawn
    Lake Success, New York, 11042, United States
  • Dana Farber Cancer Institute /ID# 154210 accepting new patients
    Boston, Massachusetts, 02215, United States
  • Cork University Hospital /ID# 136828 completed
    Cork, Ireland
  • Beaumont Hospital /ID# 136829 in progress, not accepting new patients
    Dublin, D09, Ireland
  • Queen Elizabeth Hospital /ID# 136978 accepting new patients
    Edgbaston, B15 2WB, United Kingdom
  • Beatson West of Scotland Cancer Centre /ID# 136979 accepting new patients
    Glasgow, G12 OYN, United Kingdom
  • Hull and East Yorkshire NHS Trust /ID# 136917 accepting new patients
    Hull, HU16 5JQ, United Kingdom
  • University College London Hospitals NHS Foundation Trust /ID# 136879 accepting new patients
    London, NW1 2PG, United Kingdom
  • Guys and St. Thomas' NHS Foundation Trust /ID# 140312 accepting new patients
    London, SE1 7EH, United Kingdom
  • Great Ormond Streeet Hospital NHS Trust for children /ID# 153421 accepting new patients
    London, WC1N 3JH, United Kingdom
  • The Christie NHS Foundation Trust /ID# 140313 accepting new patients
    Manchester, M20 4BX, United Kingdom
  • Helsinki University Hospital/Children's Hospital /ID# 153069 accepting new patients
    Helsinki, 00029, Finland
  • Helsinki University Central Hospital /ID# 140078 accepting new patients
    Helsinki, FIN-00029 HUS, Finland
  • Turku University Hospital /ID# 140861 accepting new patients
    Turku, 20521, Finland
  • Vrije Universiteit Medical Center /ID# 137221 accepting new patients
    Amsterdam, 1081 HV, Netherlands
  • Universitair Medisch Centrum Groningen /ID# 138266 accepting new patients
    Groningen, 9713 GZ, Netherlands
  • Erasmus Medisch Centrum /ID# 136981 accepting new patients
    Rotterdam, 3075 EA, Netherlands
  • MC Haaglanden - Westeinde /ID# 137222 accepting new patients
    The Hague, 2512 VA, Netherlands
  • UMC Utrecht /ID# 137219 accepting new patients
    Utrecht, 3584 CX, Netherlands
  • ZNA Middelheim /ID# 137926 accepting new patients
    Antwerp, 2020, Belgium
  • AZ St-Jan Brugge-Oostende AV - Campus Sint Jan /ID# 137927 accepting new patients
    Bruges, 8000, Belgium
  • Cliniques Universitaires Saint-Luc /ID# 139391 accepting new patients
    Brussels, 1200, Belgium
  • Grand Hopital de Charleroi /ID# 139342 accepting new patients
    Charleroi, 6000, Belgium
  • Universitair Ziekenhuis Gent /ID# 152944 not yet accepting patients
    Ghent, 9000, Belgium
  • Universitair Ziekenhuis Leuven /ID# 137925 accepting new patients
    Leuven, 3000, Belgium
  • Seoul National University Bundang Hospital /ID# 136841 accepting new patients
    Seongnam-si, 463-707, Korea, Republic of
  • Seoul National University Hospital /ID# 136840 accepting new patients
    Seoul, 03080, Korea, Republic of
  • Samsung Medical Center /ID# 136842 accepting new patients
    Seoul, 06351, Korea, Republic of
  • Institut de Cancer de l'Ouest- Site Paul Papin /ID# 137909 accepting new patients
    Angers cedex 2, 49055, France
  • CHU-Hopital Avicenne /ID# 137910 accepting new patients
    Bobigny, 93000, France
  • Hospices Civils de Lyon /ID# 137913 accepting new patients
    Bron, 69677, France
  • CHRU de Lille /ID# 137916 accepting new patients
    Lille, 59037, France
  • Centre Leon Berard /ID# 137918 accepting new patients
    Lyon, Cedex 8, 69373, France
  • Hopital de la Timone /ID# 137911 accepting new patients
    Marseille, 13005, France
  • CHU de Nice /ID# 137917 accepting new patients
    Nice, 06001, France
  • Groupe Hospitalier Pitie-Salpetriere /ID# 145887 accepting new patients
    Paris, Cedex 13, 75651, France
  • Insititut de Cancerologie de l'Ouest -Centre Rene Gauducheau /ID# 137914 accepting new patients
    Saint Herbalin, 44800, France
  • Gustave Roussy /ID# 137912 accepting new patients
    Villejuif Cedex, 94805, France
  • Universitaetsklinikum Eppendorf Hamburg-CeDeF /ID# 137921 in progress, not accepting new patients
    Hamburg, 20246, Germany
  • Universitaetsklinikum Heidelberg Hautklinik /ID# 137924 completed
    Heidelberg, 69120, Germany
  • Universitatsklinik Regensburg /ID# 137920 in progress, not accepting new patients
    Munich, Bayern, 93053, Germany
  • Klinikum der Universitaet Munich /ID# 137922 accepting new patients
    Munich, 81377, Germany
  • Universitaetsklinikum Tuebingen /ID# 137923 in progress, not accepting new patients
    Tuebingen, 72076, Germany
  • Instituto Catalan de Oncologia, L'Hospitalet de Llobregat /ID# 137688 accepting new patients
    Barcelona, 08908, Spain
  • Instituto Catalan de Oncologia, L'Hospitalet de Llobregat /ID# 140976 accepting new patients
    Barcelona, 08916, Spain
  • Hospital Universitario Nino Jesus /ID# 153800 accepting new patients
    Madrid, 28009, Spain
  • Hospital Universitario 12 de Octubre /ID# 137908 accepting new patients
    Madrid, 28041, Spain
  • Clinica Universitaria de Navarra /ID# 140047 accepting new patients
    Pamplona (Navarra)-Espana, 31008, Spain
  • Uniwersyteckie Centrum Klinicze /ID# 137919 accepting new patients
    Gdansk, 80-952, Poland
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi /ID# 137654 accepting new patients
    Lodz, 93-513, Poland
  • Centre Hospitalier Universiaire Vaudois Lausanne (CHUV) /ID# 137929 in progress, not accepting new patients
    Lausanne, 1011, Switzerland
  • University Hospital Zurich /ID# 137930 in progress, not accepting new patients
    Zurich, 8091, Switzerland
  • Masarykuv onkologicky ustav /ID# 139508 accepting new patients
    Brno, 656 53, Czechia
  • Fakultni Nemocnice Hradec Kralove /ID# 139510 accepting new patients
    Hradec Kralove, 500 05, Czechia
  • Fakultni Nemocnice Ostrava /ID# 139507 accepting new patients
    Ostrava, 708 52, Czechia
  • Fakultni Nemocnice v Motole /ID# 139509 accepting new patients
    Prague 5, 150 06, Czechia
  • Medizinische Universitat Graz /ID# 139071 completed
    Graz, 8036, Austria
  • Kepler Universitatskliniken GmbH - Neuromed Campus /ID# 139068 in progress, not accepting new patients
    Linz, 4020, Austria
  • University Hospital St. Polten /ID# 139070 in progress, not accepting new patients
    St. Poelten, 3100, Austria
  • Orszagos Onkologiai Intezet /ID# 135970 completed
    Budapest, 1122, Hungary
  • Orszagos Klinikai Idegtudomanyi Intezet /ID# 135971 accepting new patients
    Budapest, 1145, Hungary
  • Semmelweis Egyetem /ID# 152578 accepting new patients
    Budapest, H-1094, Hungary
  • Debreceni Egyetem /ID# 135969 in progress, not accepting new patients
    Debrecen, 4032, Hungary
  • Pecsi Tudomanyegyetem /ID# 136111 completed
    Pecs, 7624, Hungary
  • Istituto delle Scienze Neurologiche di Bologna /ID# 138335 accepting new patients
    Bologna, 40139, Italy
  • Ospedale Generale di Bolzano /ID# 138338 accepting new patients
    Bolzano, 39100, Italy
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 140395 accepting new patients
    Milan, 20133, Italy
  • Istituto Oncologico Veneto /ID# 138336 accepting new patients
    Padova, 35128, Italy
  • Azienda Ospedaliera Sant' Andrea /ID# 138337 accepting new patients
    Rome, 00189, Italy
  • China Medical University Hospital /ID# 136976 accepting new patients
    Taichung City, 404, Taiwan
  • Taichung Veterans General Hospital /ID# 136977 accepting new patients
    Taichung, 40705, Taiwan
  • National Taiwan University Hospital /ID# 136975 accepting new patients
    Taipei City, 10002, Taiwan
  • Taipei Veterans General Hospital /ID# 136974 accepting new patients
    Taipei City, 11217, Taiwan
  • LinKuo Chang Gung Memorial Hospital /ID# 136944 accepting new patients
    Taoyuan County, Taiwan
  • Royal Adelaide Hospital /ID# 135208 accepting new patients
    Adelaide, 5000, Australia
  • Barwon Health, University Hospital of Geelong /ID# 134493 accepting new patients
    Geelong, 3220, Australia
  • Royal Brisbane and Women's Hospital /ID# 147091 accepting new patients
    Herston, 4029, Australia
  • Royal Hobart Hospital /ID# 135209 accepting new patients
    Hobart, 7000, Australia
  • Royal Children's Hospital /ID# 157624 accepting new patients
    Parkville, 3052, Australia
  • Port Macquarie Base Hospital /ID# 134569 accepting new patients
    Port Macquarie, 2444, Australia
  • Sydney Children's Hospital /ID# 153533 not yet accepting patients
    Randwick, 2031, Australia
  • Royal North Shore Hospital /ID# 147092 accepting new patients
    St. Leonards, 2065, Australia
  • Calvary Mater Newcastle /ID# 134570 accepting new patients
    Waratah, 2298, Australia
  • Southern Medical Day Care Center /ID# 134495 accepting new patients
    Wollongong, 2500, Australia
  • National University Hospital /ID# 135951 accepting new patients
    Singapore, 119074, Singapore
  • National Cancer Centre Singapore /ID# 135952 accepting new patients
    Singapore, 169610, Singapore
  • KK Women's and Children Hospital /ID# 153676 not yet accepting patients
    Singapore, 229899, Singapore

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02343406
Phase
Phase 2
Lead Scientist
Theodore Nicolaides
Study Type
Interventional
Last Updated
August 16, 2017
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