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NCT06388733 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
A Phase 3 study of Glioblastoma and Brain Tumor, sponsored by Ivy Brain Tumor Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06388733 is a Phase 3 study of Glioblastoma and Brain Tumor that is actively recruiting participants, run by Ivy Brain Tumor Center. The registered enrollment target is 450 participants, above the 107-participant average among 199 other Glioblastoma trials with a reported enrollment target (321% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT06388733, a Phase 3 study of Glioblastoma and Brain Tumor, is actively recruiting participants, sponsored by Ivy Brain Tumor Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Niraparib
Study Locations (20)
New York
- Northwell Health - New Hyde Park
- New York University Ambulatory Care Center - New York
- Montefiore Medical Center - The Bronx
California
- Scripps Cancer Center - La Jolla
- Moores UCSD Cancer Center - La Jolla
Minnesota
- Allina Health - Minneapolis
- University of Minnesota Health Clinics and Surgery Center, Minneapolis - Minneapolis
Missouri
- Saint Lukes Neuro Oncology - Kansas City
- Washington University, School of Medicine - St Louis
North Carolina
- Duke Cancer Center Brain Tumor Clinic - Durham
- Wake Forest Baptist Health - Winston-Salem
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Ivy Brain Tumor Center - Phoenix
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-06-19 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06388733
The ClinicalTrials.gov registry entry for NCT06388733 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 199 other Glioblastoma trials with a reported enrollment target (321% higher). The listed sponsor is Ivy Brain Tumor Center, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.
NCT06388733 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06388733 about?
NCT06388733 is a clinical study titled "A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma". 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...
What is the current status of trial NCT06388733?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2024-06-19. Estimated completion is 2028-03.
What conditions does trial NCT06388733 study?
This clinical trial studies the following conditions: Glioblastoma, Brain Tumor, GBM, Brain Neoplasms, Adult, Malignant.
What interventions are being tested in trial NCT06388733?
The interventions under investigation include: Temozolomide (DRUG), Niraparib (DRUG).
Who is sponsoring clinical trial NCT06388733?
This trial is sponsored by Ivy Brain Tumor Center, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06388733 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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