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NCT06388733 · ClinicalTrials.gov record · last posted 2026-07-01

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

StatusActive, Not Recruiting
PhasePhase 3
Started2024-06-19
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The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main question it aims to answer is: Does niraparib improve overall survival (OS) compared to TMZ? Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. * study drug (Niraparib) or * comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. Participants' tasks will include: * Complete study visits as scheduled * Complete a diary to record study medication

Protocol amendment history 1 change detected by DataLookout

2026-07-02
Trial status changed: Recruiting → Active, Not Recruiting
Trial Details
NCT Number NCT06388733
Lead Sponsor Ivy Brain Tumor Center
Collaborators: GlaxoSmithKline
Conditions Glioblastoma, GBM, Brain Neoplasms, Adult, Malignant, Brain Tumor
Enrollment 450 participants
Start Date 2024-06-19
Primary Completion 2027-12 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-01