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ACTIVE NOT RECRUITING
NCT05406700
EARLY_PHASE1

Niraparib In Recurrent IDH 1/2 Gliomas

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

This is a randomized, two-arm, open-label, phase 0 trial to assess intratumoral pharmacokinetics and pharmacodynamics of niraparib in subjects with progressive IDH1 or IDH2 mutant glioma. \- This research study involves an experimental treatment called Niraparib.

Official title: A Phase 0 Clinical Trial to Evaluate Drug Concentrations and Pharmacodynamic Parameters of Niraparib in Tumor Tissue of Patients With Surgically Accessible Recurrent IDH 1/2 Gliomas

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2023-05-18

Completion Date

2026-10

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

DRUG

Niraparib

Oral, daily, dosage per protocol,4 Weeks

DRUG

Resection/Treatment with Niraparib

The participants in both arms will resume/start on treatment with niraparib 2 -4 weeks after surgery. Treatment can be held for an additional 28 days to allow for recovery from surgery, at the investigator's discretion. Participants will continue treatment for up to 12 total cycles of treatment or until tumor progression, unacceptable toxicity or withdrawal of consent.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States