Niraparib In Recurrent IDH 1/2 Gliomas

Glioma, Malignant Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05406700
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Isabel Arrillaga-Romany, MD, PhD
• Phone: (617) 724-4000
• Email: iarrillaga@mgh.harvard.edu
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 18, 2023
• Completion date: February 2026