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Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma

NCT05076513 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-09

No results posted yet for this study

Summary

This is an open-label, multi-center Phase 0 study with an expansion phase that will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss. The trial will be composed of a Phase 0 component (subdivided into Arm A and B) and a therapeutic expansion phase. Patients with tumors demonstrating a positive PK Response (in Arm A) or a positive PD Response (in Arm B) of the Phase 0 component of the study will graduate to a therapeutic expansion phase that combines therapeutic dosing of niraparib plus standard-of-care fractionated radiotherapy (in Arm A) or niraparib monotherapy (in Arm B) until progression of disease.

Conditions

Interventions

DRUG

Niraparib

In Phase 0, 300mg administered orally QD for 4 days prior to resection. In the Expansion cohort/Maintenance phase, niraparib will be administered as described below: * For patients weighing \<77 kg (\<170 lbs) OR with a platelet count \<150,000/mcL, the recommended dosage is 200 mg taken orally once daily. * For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/ mcL, the recommended dosage is 300 mg taken orally once daily.

RADIATION

Radiation therapy

Participants in Arm A who move onto the Expansion cohort will receive 6-7 weeks of radiation therapy per standard of care.

Sponsors & Collaborators

Principal Investigators

  • Nader Sanai, MD · Chief Scientific Officer/Director of the Ivy Brain Tumor Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2024-03-19
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT05076513 on ClinicalTrials.gov