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Niraparib In Recurrent IDH 1/2 Gliomas

NCT05406700 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-09

No results posted yet for this 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 glioma.

\- This research study involves an experimental treatment called Niraparib.

Conditions

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

Interventions

DRUG

Niraparib

Oral, daily, dosage per protocol,4 Weeks

DRUG

Resection/Treatment with Niraparib

The participants in both arms will resume/start on treatment with niraparib 2 -4 weeks after surgery. Treatment can be held for an additional 28 days to allow for recovery from surgery, at the investigator's discretion. Participants will continue treatment for up to 12 total cycles of treatment or until tumor progression, unacceptable toxicity or withdrawal of consent.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Isabel Arrillaga-Romany, MD, Phd · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2026-07-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406700 on ClinicalTrials.gov