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ACTIVE NOT RECRUITING
NCT05076513
EARLY_PHASE1

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

Sponsor: Nader Sanai

View on ClinicalTrials.gov

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.

Official title: A Phase 0 'Trigger' Trial of Niraparib in Newly-diagnosed Glioblastoma and Recurrent IDH1/2(+) ATRX Mutant Glioma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2021-10-29

Completion Date

2027-03

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Niraparib

In Phase 0, 300mg administered orally QD for 4 days prior to resection. In the Expansion cohort/Maintenance phase, niraparib will be administered as described below: * For patients weighing \<77 kg (\<170 lbs) OR with a platelet count \<150,000/mcL, the recommended dosage is 200 mg taken orally once daily. * For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/ mcL, the recommended dosage is 300 mg taken orally once daily.

RADIATION

Radiation therapy

Participants in Arm A who move onto the Expansion cohort will receive 6-7 weeks of radiation therapy per standard of care.

Locations (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States