Could a pill reach and fight aggressive brain tumors? early trial hints at possibility
NCT ID NCT05076513
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests the drug niraparib (Zejula) in people with two types of brain cancer: newly diagnosed glioblastoma and recurrent glioma with specific genetic changes (IDH mutation and ATRX loss). The study first checks if the drug reaches the tumor tissue, then gives it to those who show a response, combined with radiation or alone. Up to 42 participants will be enrolled to see if niraparib can slow tumor growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Niraparib (Zejula), a cancer drug taken as a pill
- What this could lead to
- If successful, this could point toward a new treatment option for aggressive brain cancers like glioblastoma and certain recurrent gliomas.
- What could go wrong
- This is a very early (Phase 0) trial with only 42 participants, so it is too soon to know if niraparib will be effective or safe for these brain cancers. The drug may not work as hoped or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Arm A participants undergoing resection for a suspected newly diagnosed glioblastoma. For Arm B, participants undergoing resection who have had a prior resection of histologically diagnosed WHO grade II-IV glioma with IDH1 or IDH2 mutation and ATRX loss. 2. Arm A participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm. 3. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable). 4. Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. 5. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures. 6. Age ≥18 at time of consent 7. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982) 8. Ability to swallow oral medications. 9. Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause. If the serum pregnancy test is completed \> 7 days from Day 1, a urine pregnancy test will be done to confirm a negative result prior to Day 1 dose administration. 10. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to treatment and agreement to use such a method during study participation and for an additional 6 months after the end of treatment administration. 11. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 3 months after the end of treatment administration. Avoid sperm donation for duration of the study and for an additional 6 months after the end of treatment administration. 12. Agreement to adhere to Lifestyle Considerations throughout study duration. 13. Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 21 days is required between last chemotherapy and Day 1. 14. Females of child-bearing potential must agree not to breastfeed starting at screening, throughout the study period and for 6 months after final study drug administration. 15. Participant has normal blood pressure or adequately treated and controlled hypertension (Defined as systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg). 16. Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility): * Adequate Bone Marrow Function: * Absolute Neutrophil Count ≥1,500/mcL * Platelets (at time of surgery) ≥100,000/mcL * Hemoglobin ≥9.0 g/dL. Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion. * Adequate Hepatic Function: * Total Bilirubin ≤1.5 X ULN. Participants with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted. * AST(SGOT) ≤2.5 X institutional ULN * ALT(SGPT) ≤2.5 X institutional ULN * Adequate Renal Function: * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 by Chronic Disease Epidemiology Collaboration (CKD-EPI) equation * INR ≤1.5 x ULN Exclusion Criteria: 1. Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise, that cannot be discontinued prior to surgery. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed. 2. Pregnancy or lactation. 3. Known allergic reactions to components of the niraparib tablet, including FD\&C Yellow No. 5.. 4. Active infection or fever \>38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1. 5. Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis as determined by the investigator. 6. Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment. 7. Any of the following cardiovascular criteria: * Current evidence of cardiac ischemia * Current symptomatic pulmonary embolism * Acute myocardial infarction ≤ 6 months prior to Day 1 * Heart failure of New York Heart Association Classification III or IV ≤ 6 months prior to Day 1 (Appendix 13.2) * Grade ≥ 2 ventricular arrhythmia ≤ 6 months prior to Day 1 * Cerebral vascular accident (CVA) or transient ischemic attack (TIA) ≤ 6 months prior to Day 1 8. Participant has myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML. 9. Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). 10. Prior therapy with PARP inhibitors at a therapeutic dose. 11. Treatment with another investigational drug or other intervention within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
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