drugset / Trial / NCT05076513
Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
Phase 0
Active not recruiting
42 enrolled
Nader Sanai
Barrow Neurological Institute · collabGlaxoSmithKline · collabIvy Brain Tumor Center · collabUniversity of California, San Francisco · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-10-29
- Primary completion
- 2024-03-19
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niraparib | Small molecule | 200 mg | Oral |
| Subject | Niraparib | Small molecule | 300 mg | Oral |