450
Participants
Start Date
January 23, 2023
Primary Completion Date
August 31, 2026
Study Completion Date
August 31, 2026
Dordaviprone (ONC201)
Participants ≥ 52.5 kg will receive 625 mg of ONC201 (5 × 125-mg capsules) dosing days; participants \< 52.5 kg will receive a dose (and corresponding number of capsules) scaled by body weight and rounded to 125-mg increments.
Dordaviprone (ONC201) + Placebo
Participants ≥ 52.5 kg will receive 625 mg of ONC201 (5 × 125-mg capsules) or matching placebo on dosing days; participants \< 52.5 kg will receive a dose (and corresponding number of capsules) scaled by body weight and rounded to 125-mg increments
Placebo
Participants will receive placebo (same number of capsules as the ONC201 dose) on dosing days
RECRUITING
Centre Hospitalier Universitaire Vaudois, Lausanne
RECRUITING
Sydney Children's Hospital, Randwick
RECRUITING
Royal North Shore Hospital, Sydney
RECRUITING
Copenhagen University Hospital, Copenhagen
RECRUITING
Olivia Newton-John Cancer Research Institute (ONJCRI), Heidelberg
RECRUITING
F345 H.C. Andersen's Children's Hospital, Odense
RECRUITING
Odense Universitetshospital, Odense
RECRUITING
Asan Medical Center, Seoul
RECRUITING
Perth Children's Hospital, Nedlands
RECRUITING
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
RECRUITING
Royal Hobart Hospital, Hobart
RECRUITING
Hospital Universitario Vall d'Hebron, Barcelona
RECRUITING
Universitätsspital Zürich, Zurich
RECRUITING
Hospital Sant Joan de Deu, Esplugues de Llobregat
RECRUITING
Aalborg Universitetshospital, Aalborg
ACTIVE_NOT_RECRUITING
Children's Hospital at Montefiore Medical Center, New York
ACTIVE_NOT_RECRUITING
Montefiore Medical Park, New York
ACTIVE_NOT_RECRUITING
Columbia University Medical Center, New York
ACTIVE_NOT_RECRUITING
Lenox Hill Hospital, New York
RECRUITING
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin
RECRUITING
National Cancer Center, Ilsandong-Gu, Goyang-Si
ACTIVE_NOT_RECRUITING
Albany Medical Center, Albany
RECRUITING
Vivantes Klinikum Neukölln, Berlin
RECRUITING
CHA Bundang Medical Center, Bundang-Gu, Seongnam-Si
RECRUITING
Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si
RECRUITING
Seoul National University Hospital, Bundang-gu, Seongnam-si
ACTIVE_NOT_RECRUITING
University of Rochester Medical Center, Rochester
ACTIVE_NOT_RECRUITING
UPMC Children's Hospital of Pittsburgh, Pittsburgh
ACTIVE_NOT_RECRUITING
UPMC Hillman Cancer Center, Pittsburgh
ACTIVE_NOT_RECRUITING
University of Pennsylvania, Philadelphia
ACTIVE_NOT_RECRUITING
Thomas Jefferson University, Philadelphia
ACTIVE_NOT_RECRUITING
MedStar Georgetown University Hospital, Washington D.C.
RECRUITING
Istituto Clinico Humanitas, Rozzano
RECRUITING
Ospedale San Raffaele S.r.l., Milan
RECRUITING
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta, Milan
ACTIVE_NOT_RECRUITING
University of Maryland School of Medicine, Baltimore
ACTIVE_NOT_RECRUITING
Inova Schar Cancer Institute, Fairfax
ACTIVE_NOT_RECRUITING
Children's Hospital of The King's Daughter, Norfolk
ACTIVE_NOT_RECRUITING
Duke Cancer Institute, Durham
RECRUITING
Hospital Infantil Universitario Niño Jesus, Madrid
RECRUITING
Hospital Universitario 12 de Octubre, Madrid
RECRUITING
Hospital Universitario HM Sanchinarro, Madrid
ACTIVE_NOT_RECRUITING
Levine Cancer Institute/ Atrium Health, Charlotte
ACTIVE_NOT_RECRUITING
Children's Healthcare of Atlanta, Atlanta
RECRUITING
Clinica Universidad Navarra, Pamplona
RECRUITING
Rambam Medical Center, Haifa
ACTIVE_NOT_RECRUITING
Mayo Clinic Jacksonville, Jacksonville
ACTIVE_NOT_RECRUITING
Miami Cancer Institute, Miami
WITHDRAWN
Cleveland Clinic Florida, Weston
ACTIVE_NOT_RECRUITING
St Joseph's Children's Hospital of Tampa, Tampa
ACTIVE_NOT_RECRUITING
Moffitt Cancer Center, Tampa
RECRUITING
Istituto Oncologico Veneto, Padua
RECRUITING
Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca
RECRUITING
Ospedale Bellaria, Bologna
ACTIVE_NOT_RECRUITING
Norton Healthcare, Louisville
ACTIVE_NOT_RECRUITING
Ohio State University, Columbus
ACTIVE_NOT_RECRUITING
Cleveland Clinic, Cleveland
RECRUITING
Universitätsklinikum Essen, Essen
ACTIVE_NOT_RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
RECRUITING
Hospital Universitari i Politecnic La Fe de Valencia - Adults, Valencia
RECRUITING
Hospital Universitari i Politecnic La Fe de Valencia - Pediatrics, Valencia
ACTIVE_NOT_RECRUITING
Indiana University School of Medicine - Indianapolis, Indianapolis
ACTIVE_NOT_RECRUITING
University of Michigan Hospital, Ann Arbor
RECRUITING
Rabin Medical Center, Petah Tikva
RECRUITING
Uniklinik Köln, Cologne
RECRUITING
Soroka University Medical Centre, Beersheba
ACTIVE_NOT_RECRUITING
University of Iowa Hospitals & Clinics, Iowa City
RECRUITING
Universitätsklinikum Bonn, Bonn
ACTIVE_NOT_RECRUITING
University Of Wisconsin - Madison, Madison
ACTIVE_NOT_RECRUITING
University of Minnesota, Minneapolis
ACTIVE_NOT_RECRUITING
Mayo Clinic - Cancer Center - Rochester, Rochester
WITHDRAWN
Benefis Hospital Sletten Cancer Institute, Great Falls
RECRUITING
Klinikum der Johann-Wolfgang Goethe-Universitat, Frankfurt am Main
ACTIVE_NOT_RECRUITING
Feinberg School of Medicine Northwestern University, Chicago
ACTIVE_NOT_RECRUITING
Washington University School of Medicine/St. Louis Children's Hospital, St Louis
RECRUITING
Tel Aviv Sourasky Medical Center, Tel Aviv
ACTIVE_NOT_RECRUITING
University of Nebraska Medical Center, Omaha
RECRUITING
Klinikum Mannheim Universitätsklinikum gGmbH, Manheim
RECRUITING
University Clinic Heidelberg, Heidelberg
RECRUITING
Universitätsklinikum Heidelberg, Heidelberg
ACTIVE_NOT_RECRUITING
Ochsner Medical Center - New Orleans, New Orleans
RECRUITING
Universitätsklinikum Tübingen, Tübingen
ACTIVE_NOT_RECRUITING
University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City
ACTIVE_NOT_RECRUITING
Neuro-Oncology Associates, Dallas
ACTIVE_NOT_RECRUITING
University of Texas Southwestern Medical Center, Dallas
ACTIVE_NOT_RECRUITING
University of Texas MD Anderson Cancer Center, Houston
ACTIVE_NOT_RECRUITING
UT Health Houston Neurosciences - Texas Medical Center, Houston
ACTIVE_NOT_RECRUITING
University of Texas - San Antonio - Health Science Center, San Antonio
ACTIVE_NOT_RECRUITING
Dell Children's Medical Center of Central Texas, Austin
ACTIVE_NOT_RECRUITING
University of Utah - Huntsman Cancer Institute, Salt Lake City
ACTIVE_NOT_RECRUITING
Banner MD Anderson Cancer Center, Phoenix
ACTIVE_NOT_RECRUITING
Barrow Neurological Institute, Phoenix
ACTIVE_NOT_RECRUITING
Phoenix Childrens Hospital, Phoenix
ACTIVE_NOT_RECRUITING
Mayo Clinic Arizona, Phoenix
RECRUITING
Universitätsklinikum Augsburg, Augsburg
ACTIVE_NOT_RECRUITING
Kaiser Permanente Los Angeles Medical Center, Los Angeles
ACTIVE_NOT_RECRUITING
UCLA University of California Los Angeles, Los Angeles
ACTIVE_NOT_RECRUITING
Providence Saint John's Cancer Institute, Santa Monica
RECRUITING
Hadassah Ein Kerem Medical Center, Jerusalem
ACTIVE_NOT_RECRUITING
UC San Diego Moores Cancer Center, La Jolla
WITHDRAWN
Children's Hospital of Orange County, Orange
ACTIVE_NOT_RECRUITING
University of California Irvine, Orange
RECRUITING
University Clinic Regensburg, Regensburg
ACTIVE_NOT_RECRUITING
UCSF Benioff Children's Hospital, San Francisco
ACTIVE_NOT_RECRUITING
University of California San Francisco, San Francisco
ACTIVE_NOT_RECRUITING
Stanford Cancer Center, Stanford
ACTIVE_NOT_RECRUITING
Kapi'olani Medical Center for Women and Children, Honolulu
ACTIVE_NOT_RECRUITING
Providence Health and Services St. Vincent Medical Center, Portland
ACTIVE_NOT_RECRUITING
University of Washington, Seattle
RECRUITING
KK Women's and Children's Hospital, Singapore
RECRUITING
National Cancer Centre, Singapore
RECRUITING
National Neuroscience Institute, Singapore
RECRUITING
Queen Mary Hospital, Hong Kong
RECRUITING
Schneider Children's Medical Center of Israel, Petah Tikvah
RECRUITING
Sheba Medical Center, Ramat Gan
ACTIVE_NOT_RECRUITING
Yale University, New Haven
ACTIVE_NOT_RECRUITING
Massachusetts General Hospital Cancer Center, Boston
ACTIVE_NOT_RECRUITING
Dana Farber Cancer Institute, Boston
ACTIVE_NOT_RECRUITING
Jersey Shore University Medical Center, Neptune City
ACTIVE_NOT_RECRUITING
Overlook Medical Center, Summit
ACTIVE_NOT_RECRUITING
Laura & Isaac Perlmutter Cancer Center - NYU ACC, New York
RECRUITING
FLENI Neurologia, Buenos Aires
RECRUITING
Royal Brisbane and Women's Hospital, Herston
RECRUITING
Medical University of Vienna - Pediatrics, Vienna
RECRUITING
Hcor Research Institute, São Paulo
RECRUITING
Instituto Do Cancer Do Estado De São Paulo, São Paulo
RECRUITING
The University of Tokyo Hospital, Tokyo
RECRUITING
Medical University of Vienna - Adults, Vienna
RECRUITING
Hospital do GRAACC, São Paulo
RECRUITING
Tom Baker Cancer Cetre, Calgary
RECRUITING
BC Cancer - The Vancouver Center, Vancouver
RECRUITING
Children's & Women's Health Care of BC, Vancouver
RECRUITING
London Health Sciences Centre, London
RECRUITING
Childrens Hospital of Eastern Ontario, Ottawa
RECRUITING
Sunnybrook Health Sciences Centre, Toronto
RECRUITING
Princess Margaret Hospital, Toronto
RECRUITING
Hopital Notre Dame, Lachapelle, Montreal
WITHDRAWN
Istituto Nazionale Tumori Regina Elena, Rome
RECRUITING
National Cancer Center Hospital, Chūō
RECRUITING
National Hospital Organization Kyushu Cancer Center, Fukuoka
RECRUITING
Kyoto University Hospital, Kyoto
RECRUITING
Osaka City General Hospital, Osaka
RECRUITING
Hokkaido University Hospital, Sapporo
RECRUITING
Erasmus MC, Rotterdam
RECRUITING
Universitair Medisch Centrum Utrecht Cancer Center, Utrecht
RECRUITING
Gangnam Severance Hospital, Yonsei University Health System, Gangnam
RECRUITING
Samsung Medical Center, Gangnam-Gu
RECRUITING
Seoul National University Hospital, Jongno-Gu
RECRUITING
Severance Hospital Yonsei University Health System, Seoul
RECRUITING
Hospital Clinic de Barcelona, Barcelona
RECRUITING
Addenbrooke's Hospital, Cambridge
RECRUITING
Beatson West of Scotland Cancer Centre, Glasgow
RECRUITING
Royal Hospital for Children (Glasgow), Glasgow
RECRUITING
Clatterbridge Cancer Centre - Liverpool, Liverpool
RECRUITING
The Christie NHS Foundation Trust, Manchester
RECRUITING
The Royal Marsden in Sutton, Surrey, Sutton
RECRUITING
Royal Victoria Infirmary, Newcastle upon Tyne
RECRUITING
Freeman Hospital, Newcastle upon Tyne
RECRUITING
St James University Hospital, Leeds
RECRUITING
The Leeds Teaching Hospitals NHS Trust, Leeds General Infimary, Leeds
RECRUITING
Guy's Hospital, London
RECRUITING
Churchill Hospital, Oxford
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY