Loading clinical trials...
Loading clinical trials...
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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
May 18, 2023
Primary Completion Date
July 1, 2026
Completion Date
October 1, 2026
Last Updated
February 9, 2026
16
ESTIMATED participants
Niraparib
DRUG
Resection/Treatment with Niraparib
DRUG
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT07074756
NCT06910306
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03749187