A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
Public ClinicalTrials.gov record NCT06388733. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Open-label, Randomized 2-arm Study Comparing the Clinical Efficacy and Safety of Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06388733
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 450 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 18, 2024
- Primary completion
- Nov 30, 2027
- Completion
- Feb 29, 2028
- Last update posted
- Jun 30, 2026
2024 – 2028
United States locations
- U.S. sites
- 32
- U.S. states
- 22
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Ivy Brain Tumor Center | Phoenix | Arizona | 85013 | — |
| Scripps Cancer Center | La Jolla | California | 92037 | — |
| Moores UCSD Cancer Center | La Jolla | California | 92093 | — |
| Smilow Cancer Hospital at Yale New Haven | Guilford | Connecticut | 06437 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| The NeuroMedical Center | Baton Rouge | Louisiana | 70809 | — |
| MaineHealth Maine Medical Center Care | South Portland | Maine | 04106 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Allina Health | Minneapolis | Minnesota | 55407 | — |
| University of Minnesota Health Clinics and Surgery Center, Minneapolis | Minneapolis | Minnesota | 55455 | — |
| Saint Lukes Neuro Oncology | Kansas City | Missouri | 64111 | — |
| Washington University, School of Medicine | St Louis | Missouri | 63110 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| Atlantic Health System | Summit | New Jersey | 07901 | — |
| Northwell Health | New Hyde Park | New York | 11042 | — |
| New York University Ambulatory Care Center | New York | New York | 10016 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Duke Cancer Center Brain Tumor Clinic | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | 45267 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania | 15232 | — |
| Medical University of South Carolina - Department of Neurosurgery | Charleston | South Carolina | 29425 | — |
| Baylor Scott & White Health | Temple | Texas | 76508 | — |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Washington Medical Center | Seattle | Washington | 98109 | — |
| University of Wisconsin Cancer Center | Madison | Wisconsin | 53706 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06388733, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06388733 live on ClinicalTrials.gov.