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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. ;


Study Design


Related Conditions & MeSH terms


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

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