Spots Global Cancer Trial Database for ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
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Trial Identification
Brief Title: 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
Study ID: NCT05580562
Study Description
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 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.
Detailed Description:
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Barrow Neurological Institute, Phoenix, Arizona, United States
Banner MD Anderson Cancer Center, Phoenix, Arizona, United States
Phoenix Childrens Hospital, Phoenix, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
University of California Irvine, Costa Mesa, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
UCLA University of California Los Angeles, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Benioff Children's Hospital, San Francisco, California, United States
University of California San Francisco, San Francisco, California, United States
Providence Saint John's Cancer Institute, Santa Monica, California, United States
Stanford Cancer Center, Stanford, California, United States
Yale University, Fairfield, Connecticut, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
St Joseph's Children's Hospital of Tampa, Tampa, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Kapi'olani Medical Center for Women and Children, Honolulu, Hawaii, United States
Indiana University School of Medicine - Indianapolis, Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
Norton Healthcare, Louisville, Kentucky, United States
Ochsner Medical Center - New Orleans, New Orleans, Louisiana, United States
University of Maryland School of Medicine, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Hospital, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic - Cancer Center - Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Benefis Hospital Sletten Cancer Institute, Great Falls, Montana, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Jersey Shore University Medical Center, Neptune, New Jersey, United States
Overlook Medical Center, Summit, New Jersey, United States
Albany Medical Center, Albany, New York, United States
Children's Hospital at Montefiore Medical Center, New York, New York, United States
Montefiore Medical Park, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Levine Cancer Institute/ Atrium Health, Charlotte, North Carolina, United States
Duke Cancer Institute, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio Statue University, Columbus, Ohio, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Providence Health and Services St. Vincent Medical Center, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, United States
Neuro-Oncology Associates, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
UT Health Science Center Houston Department of Neurosurgery, Houston, Texas, United States
University of Texas - San Antonio - Health Science Center, San Antonio, Texas, United States
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Children's Hospital of The King's Daughter, Norfolk, Virginia, United States
University of Washington, Seattle, Washington, United States
University Of Wisconsin - Madison, Madison, Wisconsin, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
Royal North Shore Hospital, Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Olivia Newton-John Cancer Research Institute (ONJCRI), Heidelberg, Victoria, Australia
Perth Children's Hospital, Nedlands, Western Australia, Australia
Medical University of Vienna - Adults, Vienna, Wien, Austria
Medical University of Vienna - Pediatrics, Vienna, Wien, Austria
Tom Baker Cancer Cetre, Calgary, Alberta, Canada
BC Cancer - The Vancouver Center, Vancouver, British Columbia, Canada
Children's & Women's Health Care of BC, Vancouver, British Columbia, Canada
London Health Sciences Centre, London, Ontario, Canada
Childrens Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Notre Dame, Lachapelle, Montréal, Quebec, Canada
Copenhagen University Hospital, Copenhagen, Capital, Denmark
Aalborg Universitetshospital, Aalborg, Nordjylland, Denmark
Odense Universitetshospital, Odense, South Denmark, Denmark
University Clinic Heidelberg, Heidelberg, Baden-Württemberg, Germany
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
Universitätsklinikum Augsburg, Augsburg, Bayern, Germany
University Clinic Regensburg, Regensburg, Bayern, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat, Frankfurt am Main, Hessen, Germany
Universitätsklinikum Bonn, Bonn, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Uniklinik Köln, Köln, Nordrhein-Westfalen, Germany
Vivantes Klinikum Neukölln, Berlin, , Germany
Klinikum Mannheim Universitätsklinikum gGmbH, Manheim, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Sheba Medical Center, Ramat Gan, Tel-Aviv, Israel
Soroka University Medical Centre, Be'er Sheva, , Israel
Rambam Medical Center, Haifa, , Israel
Hadassah Ein Kerem Medical Center, Jerusalem, , Israel
Schneider Children's Medical Center of Israel, Petah Tikvah, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Ospedale Bellaria, Bologna, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena, Roma, Lazio, Italy
Ospedale San Raffaele S.r.l., Milano, Lombardia, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta, Milano, Lombardia, Italy
Istituto Clinico Humanitas, Rozzano, Lombardia, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy
Istituto Oncologico Veneto, Padova, Veneto, Italy
CHA Bundang Medical Center, Bundang-Gu, Seongnam-Si, Gyeonggido, Korea, Republic of
National Cancer Center, Ilsandong-Gu, Goyang-Si, Gyeonggido, Korea, Republic of
Samsung Medical Center, Gangnam-Gu, Seoul Teugbyeolsi, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Gangnam, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital, Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Erasmus MC, Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Utrecht Cancer Center, Utrecht, , Netherlands
Hospital Sant Joan de Deu, Esplugues De Llobregat, Barcelona, Spain
Clinica Universidad Navarra, Pamplona, Navarra, Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Infantil Universitario Niño Jesus, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud, Switzerland
Universitätsspital Zürich, Zürich, , Switzerland
Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Lanarkshire, United Kingdom
Royal Hospital for Children (Glasgow), Glasgow, Lanarkshire, United Kingdom
Clatterbridge Cancer Centre - Liverpool, Liverpool, Lancashire, United Kingdom
The Christie NHS Foundation Trust, Manchester, Lancashire, United Kingdom
The Royal Marsden in Sutton, Surrey, Sutton, Surrey, United Kingdom
Royal Victoria Infirmary, Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Freeman Hospital, Newcastle Upon Tyne, Tyne And Wear, United Kingdom
St James University Hospital, Leeds, West Yorkshire, United Kingdom
The Leeds Teaching Hospitals NHS Trust, Leeds General Infimary, Leeds, , United Kingdom
Guy's Hospital, London, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Contact Details
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