Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma

This is an open-label, multi-center Phase 0 study with an expansion phase that will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss. The trial will be composed of a Phase 0 component (subdivided into Arm A and B) and a therapeutic expansion phase. Patients with tumors demonstrating a positive PK Response (in Arm A) or a positive PD Response (in Arm B) of the Phase 0 component of the study will graduate to a therapeutic expansion phase that combines therapeutic dosing of niraparib plus standard-of-care fractionated radiotherapy (in Arm A) or niraparib monotherapy (in Arm B) until progression of disease.

NCT Number	NCT05076513
Lead Sponsor	Nader Sanai Collaborators: Barrow Neurological Institute, Ivy Brain Tumor Center, University of California, San Francisco, GlaxoSmithKline
Conditions	Glioblastoma, Glioblastoma Multiforme, Glioma, GBM, Glioma, Malignant, Glioblastoma Multiforme of Brain
Enrollment	42 participants
Start Date	2021-10-29
Primary Completion	2024-03-19 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-09