Arm A Treatment with Niraparib for Glioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Glioma+6 More
Niraparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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, non-enhancing glioma. - This research study involves an experimental treatment called Niraparib.

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Glioma

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 5 years

1 year
Intratumoral drug concentration of niraparib
PARP activity in resected tumors
Year 5
Median Overall Survival
Up to 5 years
Genomic profile
Response Rate
Up to one month after discontinuation of treatment
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0"
Month 3
D-2-hydroxyglutarate (2-HG) levels by MRS
Year 5
Median PFR
Year 5
Duration of Overall Response

Trial Safety

Safety Progress

1 of 3

Other trials for Glioma

Trial Design

2 Treatment Groups

Arm B No Treatment with Niraparib
1 of 2
Arm A Treatment with Niraparib
1 of 2
Active Control
Experimental Treatment

16 Total Participants · 2 Treatment Groups

Primary Treatment: Arm A Treatment with Niraparib · No Placebo Group · Phase < 1

Arm A Treatment with NiraparibExperimental Group · 2 Interventions: Niraparib, Resection/Treatment with Niraparib · Intervention Types: Drug, Drug
Arm B No Treatment with Niraparib
Drug
ActiveComparator Group · 1 Intervention: Resection/Treatment with Niraparib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2017
Completed Phase 2
~790

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Trial Background

Isabel Arrillaga-Romany, Principal Investigator
Principal Investigator
Massachusetts General Hospital
Closest Location: Massachusetts General Hospital · Boston, MA
Photo of Massachusetts General Hospital  1Photo of Massachusetts General Hospital  2Photo of Massachusetts General Hospital  3
1993First Recorded Clinical Trial
25 TrialsResearching Glioma
2425 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 18 years of age to participate in this study.
Participants must be ≥12 weeks from completion of radiation to the CNS.
You must have a baseline brain MRI scan within 21 days prior to treatment.
Patient must have a KPS ≥ 70.
You are on a stable or decreasing dose of glucocorticoids for 7 days prior to registration.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.