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RECRUITING Phase 3

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

NCT06388733 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 450 participants
Start Date 2024-06-19
Est. Completion 2028-03
Phase Phase 3

Sponsor

Ivy Brain Tumor Center

1 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ivy Brain Tumor Center, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06388733 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06388733?

The interventions under investigation include: Temozolomide (DRUG), Niraparib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial