NCT05297864

PARP Inhibition for Gliomas (PI-4G or π4g)

Phase II Trial of Niraparib in Patients With Recurrent Glioma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine what effects (good and bad) niraparib has on patients with recurrent brain cancer.

Detailed description

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with niraparib in the form of capsules taken every day for the first 28 days. If this dose is tolerated well, the patients will continue to take the capsules and more patients will be enrolled on the study. Patients will continue treatment with niraparib while on the study unless there is evidence of tumor growth or they experience unacceptable side effects. Patients will be monitored during treatment with tests and exams and after treatment completion for up to four years from the time they enrolled on the study.

Conditions

• Recurrent Glioblastoma
• Recurrent Astrocytoma
• Recurrent Oligodendroglioma
• Recurrent Glioma

Interventions

Type	Name	Description
DRUG	Niraparib	The starting dose will be 300 mg niraparib (or modified according patient weight and platelet count), taken orally once a day for each cycle of 28 days.

Timeline

• Start date: 2022-06-09
• Primary completion: 2023-11-14
• Completion: 2024-02-06
• First posted: 2022-03-28
• Last updated: 2025-05-23
• Results posted: 2024-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study