Arm A Treatment with Niraparib for Glioma
Phase-Based Progress Estimates
Effectiveness
Safety
Massachusetts General Hospital, Boston, MA
Glioma+6 More
Niraparib - DrugEligibility
18+
All Sexes
What conditions do you have?
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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
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
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: DrugTreatment
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
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 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.
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