NCT05406700

Niraparib In Recurrent IDH 1/2 Gliomas

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Participants will be randomized into one of two groups * Arm A: 1 cycle of Niraparib, followed by surgery, followed by up to 12 cycles of niraparib. * Arm B: Surgery followed by up to 12 cycles of niraparib Participants will receive study treatment for up to 12 Cycles (1 cycle is 28 days long) and will be followed for up to 5 years after the study treatment. It is expected that about 16 people will take part in this research study. This research study is a Pilot Study to investigate the study drug's (niraparib) activity in tumor tissue. The U.S. Food and Drug Administration (FDA) has not approved niraparib for this specific disease but it has been approved for other uses.

Conditions

• Low-grade Glioma
• IDH2 Gene Mutation
• Recurrent Glioma
• IDH1 Mutation
• Glioma, Malignant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-18
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2022-06-06
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study