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 range18 Years
SexALL
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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.
✓. 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
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 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).