Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Nader Sanai
Collaborators:
Barrow Neurological Institute GlaxoSmithKline Ivy Brain Tumor Center University of California, San Francisco