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PARP Inhibition for Gliomas (PI-4G or π4g) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

PARP Inhibition for Gliomas (PI-4G or π4g)

Phase II Trial of Niraparib in Patients With Recurrent Glioma

NCT05297864•University of Oklahoma

Summary

The purpose of this study is to determine what effects (good and bad) niraparib has on patients with recurrent brain cancer.

Detailed Description

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with niraparib in the form of capsules taken every day for the first 28 days. If this dose is tolerated well, the patients will continue to take the capsules and more patients will be enrolled on the study. Patients will continue treatment with niraparib while on the study unless there is evidence of tumor growth or they experience unacceptable side effects. Patients will be monitored during treatment with tests and exams and after treatment completion for up to four years from the time they enrolled on the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must be able to understand and willing to sign the informed consent form.
•2. Patients must be ≥ 18 years of age.
•3. Patients must have histologically proven high-grade gliomas - GBM, Astrocytoma, or Oligodendroglioma (glioma WHO Grade III or IV) that is now recurrent by MRI or surgical pathology.
•4. Patients must have measurable or evaluable lesions by RANO.
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•6. Patient has archival tumor tissue available; or a fresh biopsy of recurrent or persistent tumor must be obtained for molecular assay by myChoice test (Myriad Genetics) prior to study treatment initiation. Patient will be requested to share reports from any prior genetic testing with the study investigators.
•7. Participants have systolic BP\< 140 mmHg or diastolic BP \<90 mmHg that has been adequately treated or controlled.
•8. Have adequate organ function defined per protocol.
•9. Be able to take oral medications
•10. Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity.
+5 more criteria

Exclusion Criteria

•1. Patient has a known additional malignancy that progressed or required active treatment within the last 3 years (exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer).
•2. Prior treatment with a known poly (ADP-ribose) polymerase (PARP) inhibitor
•3. Participants with human immunodeficiency virus (HIV) with detectable viral load. Participants with HIV on effective anti-retroviral therapy with documented undetectable viral load and CD4 count ≥ 350 within 6 months of the first dose of study treatment are eligible for this trial.
•4. Known active hepatitis B or hepatitis C.
•5. Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
•6. Participant is pregnant or expecting to conceive while receiving study treatment and/or for up to 180 days after the last dose of study treatment. Patient currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of study drug.
•7. Received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 4 weeks
•8. Patients must not have a known hypersensitivity to the components of niraparib or the excipients (lactose monohydrate and magnesium stearate).
•9. Patients must not have had major surgery within 4 weeks (including craniotomy) of starting the study and patient must have recovered from any effects of any major surgery. Stereotactic biopsy by burr hole is considered a minor surgery, and those patients undergoing this surgery will be eligible for the study 2 weeks post-procedure.
•10. Patients must not have had radiotherapy encompassing \> 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
+6 more criteria

Locations (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

June 9, 2022

Primary Completion Date

November 14, 2023

Completion Date

February 6, 2024

Last Updated

May 23, 2025

Enrollment

ACTUAL participants

Conditions

Recurrent GlioblastomaRecurrent AstrocytomaRecurrent OligodendrogliomaRecurrent Glioma

Interventions

Niraparib

DRUG

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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RECRUITINGPHASE1

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

NCT06344130

AstrocytomaGlioma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2025Data synced to Clareo: March 29, 2026

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.

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PARP Inhibition for Gliomas (PI-4G or π4g)

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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