450
Participants
Start Date
June 19, 2024
Primary Completion Date
December 31, 2027
Study Completion Date
March 31, 2028
Niraparib
Participants will receive niraparib 200 mg orally once daily starting on Day 1 of RT. Following completion of RT, participants will continue niraparib adjuvant therapy orally once daily on Days 1 to 28 of each 28-day cycle until progression by BICR
Temozolomide
Participants randomized to the comparator arm (Arm B) will receive SOC TMZ 75 mg/m2 orally once daily with RT starting on Day 1 of RT. Following completion of RT, participants will complete a 4-week rest period, and then receive adjuvant TMZ 150 to 200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle until progression by BICR or for a maximum of 6 cycles.
RECRUITING
Peter MacCallum Cancer Centre, Melbourne
RECRUITING
The Alfred Hospital, Melbourne
RECRUITING
Inselspital - Universitaetsspital Bern, Bern
RECRUITING
St Vincent's Hospital Melbourne, Fitzroy
RECRUITING
Ente Ospedaliero Cantonale, Bellinzona
RECRUITING
New York University Ambulatory Care Center, New York
RECRUITING
Montefiore Medical Center, The Bronx
RECRUITING
Northwell Health, New Hyde Park
RECRUITING
Hôpital de la Timone, Marseille
RECRUITING
Hospital Universitario Reina Sofia, Córdoba
RECRUITING
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta, Girona
RECRUITING
Thomas Jefferson University, Philadelphia
RECRUITING
Istituto Clinico Humanitas, Rozzano
RECRUITING
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan
RECRUITING
Centre Georges François Leclerc, Dijon
RECRUITING
Wake Forest Baptist Health, Winston-Salem
RECRUITING
Duke Cancer Center Brain Tumor Clinic, Durham
RECRUITING
Hospital Universitario Ramon y Cajal, Madrid
RECRUITING
Hospital Universitario 12 de Octubre, Madrid
RECRUITING
Hospital Universitario HM Madrid Sanchinarro, Madrid
RECRUITING
Clinica Universidad de Navarra, Pamplona
NOT_YET_RECRUITING
Institut du Cancer de Montpellier, Montpellier
RECRUITING
University of Alabama at Birmingham, Birmingham
RECRUITING
IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna
NOT_YET_RECRUITING
Hospital Universitario Virgen del Rocio, Seville
RECRUITING
The Ohio State University, Columbus
RECRUITING
The Cleveland Clinic Foundation, Cleveland
RECRUITING
ICO - Site René Gauducheau, Saint-Herblain
RECRUITING
University of Cincinnati Cancer Institute, Cincinnati
RECRUITING
University of Michigan Rogel Cancer Center, Ann Arbor
RECRUITING
Azienda Ospedaliera Universitaria Careggi, Florence
RECRUITING
Universitaetsklinikum Bonn AoeR, Bonn
RECRUITING
University of Wisconsin Cancer Center, Madison
RECRUITING
University of Minnesota Health Clinics and Surgery Center, Minneapolis, Minneapolis
RECRUITING
Universitaetsmedizin Mannheim, Mannheim
RECRUITING
Centre Leon Berard, Lyon
RECRUITING
Universitaetsklinikum Heidelberg, Heidelberg
RECRUITING
Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer, Bron
RECRUITING
The NeuroMedical Center, Baton Rouge
RECRUITING
Universitaetsklinikum Tuebingen, Tübingen
RECRUITING
Groupe Hospitalier Pitie-Salpetriere, Paris
RECRUITING
Baylor Scott & White Health, Temple
RECRUITING
CHU Amiens-Picardie - Site Sud, Amiens
RECRUITING
Ivy Brain Tumor Center, Phoenix
RECRUITING
Scripps Cancer Center, La Jolla
RECRUITING
Moores UCSD Cancer Center, La Jolla
RECRUITING
Universitaetsklinikum Regensburg, Regensburg
RECRUITING
University of Washington Medical Center, Seattle
NOT_YET_RECRUITING
MaineHealth Maine Medical Center Care, South Portland
RECRUITING
Atlantic Health System, Summit
NOT_YET_RECRUITING
The University of Vermont Medical Center, Burlington
RECRUITING
The University of Vermont Medical Center, Burlington
RECRUITING
CHU Nice - Hôpital Pasteur, Nice
RECRUITING
Klinikum Chemnitz gGmbH, Chemnitz
RECRUITING
Universitaetsklinikum Leipzig, Leipzig
NOT_YET_RECRUITING
Maastricht UMC, Maastricht
RECRUITING
UMC Utrecht, Utrecht
NOT_YET_RECRUITING
Oslo Universitetssykehus HF, Radiumhospitalet, Oslo
RECRUITING
Hospital del Mar, Barcelona
RECRUITING
Hospital Universitari Vall d'Hebron, Barcelona
RECRUITING
Hospital Clinic de Barcelona, Barcelona
RECRUITING
The Christie Hospital, Manchester
RECRUITING
The Clatterbridge Cancer Centre, Metropolitan Borough of Wirral
RECRUITING
Beatson West of Scotland Cancer Centre, Glasgow
Collaborators (1)
GlaxoSmithKline
INDUSTRY
Ivy Brain Tumor Center
OTHER