PARP Inhibition for Gliomas (PI-4G or π4g) (NCT05297864) | Clinical Trial Compass
TerminatedPhase 2
PARP Inhibition for Gliomas (PI-4G or π4g)
Stopped: Funder terminated funding.
United States15 participantsStarted 2022-06-09
Plain-language summary
The purpose of this study is to determine what effects (good and bad) niraparib has on patients with recurrent brain cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must be able to understand and willing to sign the informed consent form.
. Patients must be ≥ 18 years of age.
. 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.
. Patients must have measurable or evaluable lesions by RANO.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients Who Experience Adverse Events
Timeframe: Up to 17 months
2
Efficacy of Treatment in Dose Expansion Phase
Timeframe: up to 12 months
3
Number of Patients Who Experience Toxicities With Individualized Starting Dose (ISD) of Niraparib Using CTCAE v5.0
. Participants have systolic BP\< 140 mmHg or diastolic BP \<90 mmHg that has been adequately treated or controlled.
. Have adequate organ function defined per protocol.
Exclusion criteria
. 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).
. Prior treatment with a known poly (ADP-ribose) polymerase (PARP) inhibitor
. 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.
. Known active hepatitis B or hepatitis C.
. Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
. 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.
. Received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 4 weeks
. Patients must not have a known hypersensitivity to the components of niraparib or the excipients (lactose monohydrate and magnesium stearate).