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NCT05297864: OU-SCC-PI-4G

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

Terminated Phase 2 Results posted Last updated 23 May 2025
What this trial tests

Phase 2 trial testing Niraparib in Recurrent Glioblastoma in 15 participants. Terminated before completion.

Timeline
9 June 2022
Primary endpoint
14 November 2023
6 February 2024

Quick facts

Lead sponsorUniversity of Oklahoma
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date9 June 2022
Primary completion14 November 2023
Estimated completion6 February 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Oklahoma

Who can join

18 and older, any sex, with Recurrent Glioblastoma or Recurrent Astrocytoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Who Experience Adverse Events Primary · Up to 17 months

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

GroupValue95% CI
Niraparib Treatment9
Efficacy of Treatment in Dose Expansion Phase Primary · up to 12 months

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.

GroupValue95% CI
Niraparib Treatment0
Number of Patients Who Experience Toxicities With Individualized Starting Dose (ISD) of Niraparib Using CTCAE v5.0 Primary · 5 months

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

GroupValue95% CI
Niraparib Treatment5
Progression Free Survival in Dose Expansion Phase Secondary · 20 months

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.

GroupValue95% CI
Niraparib Treatment1.621.06 – NA
Overall Survival in Dose Expansion Phase Secondary · 20 months

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

GroupValue95% CI
Niraparib Treatment10.814.63 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for 17 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Niraparib Treatment
Serious: 1/9 (11%)
Deaths: 6/9

Serious adverse events (2 terms)

ReactionSystemNiraparib Treatment
Death NOSGeneral disorders
Muscle weakness trunkMusculoskeletal and connective tissue disorders
Other adverse events (51 terms — click to expand)

ReactionSystemNiraparib Treatment
ConstipationGastrointestinal disorders
FatigueGeneral disorders
Platelet count decreasedInvestigations
Sinus tachycardiaCardiac disorders
NauseaGastrointestinal disorders
HeadacheNervous system disorders
HypertensionVascular disorders
AnemiaBlood and lymphatic system disorders
FallInjury, poisoning and procedural complications
DysphasiaNervous system disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
VomitingGastrointestinal disorders
Edema limbsGeneral disorders
Gait disturbanceGeneral disorders
Urinary tract infectionInfections and infestations
DizzinessNervous system disorders
Memory impairmentNervous system disorders
ConfusionPsychiatric disorders
InsomniaPsychiatric disorders
Urinary incontinenceRenal and urinary disorders
Sinus bradycardiaCardiac disorders
TinnitusEar and labyrinth disorders
Blurred visionEye disorders
Dry eyeEye disorders
DiarrheaGastrointestinal disorders
Fecal incontinenceGastrointestinal disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
Localized edemaGeneral disorders
MalaiseGeneral disorders
Alanine aminotransferase increasedInvestigations
Blood bilirubin increasedInvestigations
Creatinine increasedInvestigations
Hemoglobin increasedInvestigations
Neutrophil count decreasedInvestigations
Weight gainInvestigations
White blood cell decreasedInvestigations
DehydrationMetabolism and nutrition disorders
HyperkalemiaMetabolism and nutrition disorders
HypocalcemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders

Most-reported serious reactions: Death NOS, Muscle weakness trunk.

Data from ClinicalTrials.gov NCT05297864 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Therapies for IDH-Mutant Gliomas.
    Alshiekh Nasany R, de la Fuente MI. · · 2023 · cited 26× · PMID 37060388 · DOI 10.1007/s11910-023-01265-3
  2. The potential of PARP inhibitors in targeted cancer therapy and immunotherapy.
    Hunia J, Gawalski K, Szredzka A, Suskiewicz MJ, et al · · 2022 · cited 25× · PMID 36533080 · DOI 10.3389/fmolb.2022.1073797
  3. Mechanistic insights and the clinical prospects of targeted therapies for glioblastoma: a comprehensive review.
    Shen Y, Thng DKH, Wong ALA, Toh TB. · · 2024 · cited 12× · PMID 38615034 · DOI 10.1186/s40164-024-00512-8
  4. Combined inhibition of topoisomerase I and poly(ADP-ribose) polymerase: A synergistic therapeutic strategy for glioblastoma with phosphatase and tensin homolog deficiency.
    Kim O, Butler M, Sergi Z, Robey RW, et al · · 2023 · cited 10× · PMID 37706203 · DOI 10.1093/noajnl/vdad102
  5. Tumor Microenvironment in Gliomas: A Treatment Hurdle or an Opportunity to Grab?
    Di Nunno V, Aprile M, Gatto L, Tosoni A, et al · · 2023 · cited 8× · PMID 36831383 · DOI 10.3390/cancers15041042
  6. The Role of PARP Inhibitors in Patients with Primary Malignant Central Nervous System Tumors.
    Gueble SE, Vasquez JC, Bindra RS. · · 2022 · cited 6× · PMID 36242713 · DOI 10.1007/s11864-022-01024-5
  7. The role of molecular biomarkers in recurrent glioblastoma trials: an assessment of the current trial landscape of genome-driven oncology.
    van Opijnen MP, de Vos FYF, Cuppen E, Geurts M, et al · · 2024 · cited 2× · PMID 39316248 · DOI 10.1007/s12032-024-02501-7
  8. Atypical R-loops in cancer: decoding molecular chaos for therapeutic gain.
    Sun Y, Wang S, Ge N, Guo J, et al · · 2025 · cited 1× · PMID 40813661 · DOI 10.1186/s12967-025-06929-x

Verify or expand the search:

Other trials of Niraparib

Trials testing the same drug.

Other recruiting trials for Recurrent Glioblastoma

Currently open trials in the same condition.

Other University of Oklahoma trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05297864.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing