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Recurrent GlioblastomaPhase 2OU-SCC-PI-4GNCT05297864

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

A Phase 2 study testing Niraparib in people with Recurrent Glioblastoma and Recurrent Astrocytoma, run by University of Oklahoma at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
9 Jun 2022to 6 Feb 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Be able to take oral medications
  • Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity.
  • Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 180 days after the last dose of study treatment or is of nonchildbearing potential.
  • Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. In addition, men must not donate sperm during niraparib therapy and for 90 days after receiving the last dose of niraparib.
  • Patient must agree to not breastfeed during the study or for 30 days after the last dose of study treatment.
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Participant receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.

Who cannot join

  • 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.
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  • 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).
  • 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.
  • 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.
  • Patients must not have received a transfusion (platelets or red blood cells), colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) ≤ 4 weeks of the first dose of study treatment.
  • Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
  • Participants have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
  • Participants have received live vaccine within 30 days of planned start of study randomization.
  • Patients have medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
  • Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Phase II Trial of Niraparib in Patients With Recurrent Glioma

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

Read the 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.

Being tested
Niraparib
Keywords
high grade gliomas
Medical subject headings
Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    The starting dose will be 300 mg niraparib (or modified according patient weight and platelet count), taken orally once a day for each cycle of 28 days.

Study groups in NCT05297864
Study groupRoleWhat they receive
Niraparib TreatmentExperimentalPatients will be treated with individualized starting dose of Niraparib.
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Who Experience Adverse Events

    Number of patients who experience adverse events with individualized starting dose (ISD) of niraparib using CTCAE v5.0

    Measured: Up to 17 months

  2. Efficacy of Treatment in Dose Expansion Phase

    Percentage of patients who respond to niraparib monitored by disease control rate (stable disease and better) using RANO from start of treatment for up to 12 months.

    Measured: up to 12 months

  3. Number of Patients Who Experience Toxicities With Individualized Starting Dose (ISD) of Niraparib Using CTCAE v5.0

    Number of patients who experience toxicities (defined as grade 3 or 4 adverse events) with individualized starting dose (ISD) of niraparib using CTCAE v5.0

    Measured: 5 months

Secondary outcomes (3)

  1. Progression Free Survival in Dose Expansion Phase

    Proportion of patients who have progression-free survival from date of study entry until the first documented date of progression or date of death, whichever comes first.

    Measured: 20 months

  2. Overall Survival in Dose Expansion Phase

    Proportion of patients with overall survival on the study defined as time from date of study entry to death by any cause.

    Measured: 20 months

  3. Duration of Disease Control of All Patients

    Duration of response in patients treated with niraparib defined as time from date of first response (stable disease or better) to the first date of non-response post treatment on the study.

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start9 Jun 2022
  3. Primary completion14 Nov 2023
  4. Study completion6 Feb 2024

Why it stopped: Funder terminated funding.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297864
Sponsor's protocol ID
OU-SCC-PI-4G
Acronym
OU-SCC-PI-4G
Status last verified
May 2025
First submitted
9 Mar 2022
Last updated
23 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Recurrent Glioblastoma and Recurrent Astrocytoma, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Who Experience Adverse Events (time frame: Up to 17 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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