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Studies

Interventional Recruiting Phase 3

NCT05580562 on ClinicalTrials.gov

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)

Official title: ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

  • Sponsor: Jazz Pharmaceuticals (Group)
  • Collaborators: Chimerix, Inc.
  • Enrollment: 510 (Estimated)
  • Study start: 2023-01-23 (Actual)
  • Primary completion: 2028-06-01 (Estimated)
  • Study completion: 2028-06-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Triple (Participant, Care Provider, Investigator)
  • PrimaryPurpose: Treatment

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.

Conditions

  • H3 K27M
  • Glioma

Intervention / Treatment

  • Drug: Dordaviprone (ONC201)
  • Drug: Dordaviprone (ONC201) + Placebo
  • Other: Placebo

Primary Outcome Measures

  • Overall survival (OS) (From date of randomization until date of death from any cause, assessed up to approximately 44 months)
    Overall Survival is defined as the time from randomization to death due to any cause.

Countries

Argentina, Australia, Austria, Brazil, Canada, Denmark, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Switzerland, United Kingdom, United States

Locations and Investigators

  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino, Turin, Italy
    • Alessia, Pellerino
  • Azienda Unita' Sanitaria Locale Di Bologna, Bologna, Italy
    • Enrico, Franceschi
  • Veneto Institute Of Oncology, Padova, Italy
  • Humanitas Research Hospital, Rozzano, Italy
    • Matteo, Simonelli
  • Ospedale San Raffaele S.r.l., Milan, Italy
    • Gaetano, Finocchiaro
  • The Foundation Of The Carlo Besta Neurological Institute IRCCS, Milan, Italy
    • Paola, Gaviani
  • Hospital Infantil Universitario Nino Jesus, Madrid, Spain
    • Alvaro, Lassaletta
  • University Clinic Of Navarra, Pamplona, Spain
    • Jaime, Gallego Perez de Larraya
  • Hospital Universitario Y Politecnico La Fe, Valencia, Spain
    • Regina, Girones Sarrio
  • Hospital Universitario Y Politecnico La Fe, Valencia, Spain
    • Antonio, Juan Ribelles
  • Hospital Universitario De Salamanca, Salamanca, Spain
    • Luis Miguel, Navarro Martin
  • Hospital Universitari Vall D Hebron, Barcelona, Spain
    • Maria, Vieito Villar
  • Hospital Universitario 12 De Octubre, Madrid, Spain
    • Juan Manuel, Sepulveda Sanchez
  • Hospital Universitario Hm Sanchinarro, Madrid, Spain
    • Angela, Santiago Gomez
  • Clinica Universidad De Navarra, Madrid, Spain
    • Jaime, Gallego Perez de Larraya
  • Hospital Sant Joan De Deu Barcelona, Esplugues De Llobregat, Spain
    • Miriam, Pavon Mengual
  • Hospital Clinic De Barcelona, Barcelona, Spain
    • estela, Pineda Losada
  • Universitaetsklinikum Tuebingen, Tuebingen, Germany
  • Universitaetsklinikum Regensburg, Regensburg, Germany
    • Peter, Hau
  • Goethe University Frankfurt, Frankfurt Am Main, Germany
    • Michael, Ronellenfitsch
  • Universitaetsklinikum Heidelberg AöR, Heidelberg, Germany
    • Antje, Wick
  • Klinikum Mannheim, Mannheim, Germany
    • Lukas, Bunse
  • Vivantes - Netzwerk fuer Gesundheit GmbH, Berlin, Germany
    • Andreas, Jödicke
  • Universitaetsklinikum Essen AöR, Essen, Germany
    • Sied, Kebir
  • Universitaetsklinikum Heidelberg AöR, Heidelberg, Germany
    • Cornelis, van Tilburg
  • Universitaetsklinikum Bonn AöR, Bonn, Germany
    • Ulrich, Herrlinger
  • University Hospital Augsburg, Augsburg, Germany
    • Michael, Frühwald
  • University Hospital Cologne AöR, Cologne, Germany
    • Roland, Goldbrunner
  • Medical University of Vienna, Vienna, Austria
    • Anna, Bergmeister-Berghoff
  • Medical University of Vienna, Vienna, Austria
    • Johannes, Gojo
  • Odense University Hospital, Odense C, Denmark
    • Michael, Thude Callesen
  • Aalborg University Hospital, Aalborg, Denmark
    • Charlotte, Aaquist Haslund
  • Rigshospitalet, Copenhagen Oe, Denmark
    • Søren, Møller
  • Odense University Hospital, Odense C, Denmark
    • Rikke, Hedegaard Dahlrot
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Rotterdam, Netherlands
    • Jacoline, Bromberg
  • University Medical Center Utrecht, Utrecht, Netherlands
    • Tom, Snijders