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RECRUITING Phase 1

Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma

NCT05879367 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Interventions

  • DRUG Temozolomide
  • DRUG Eflornithine (Dose Level 1)
  • DRUG Eflornithine (Dose Level 2)
  • DRUG Eflornithine (Dose Level -1)

Study Locations (8)

Alabama

  • University of Alabama at Birmingham — Birmingham

Michigan

  • Henry Ford Hospital — Detroit

New York

  • Columbia University Medical Center - Herbert Irving Pavilion — New York

North Carolina

  • Duke University — Durham

Ohio

  • The Cleveland Clinic — Cleveland

Rhode Island

  • Brown University Health/Rhode Island Hospital — Providence

Texas

  • UT MD Anderson Cancer Center — Houston

Utah

  • University of Utah, Huntsman Cancer Institute — Salt Lake City

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2023-07-24
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Orbus Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05879367

The ClinicalTrials.gov registry entry for NCT05879367 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orbus Therapeutics, 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 7 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 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: NCT05879367 reports 8 study locations spanning 8 distinct geographic areas — top geographies include Alabama, Michigan, New York. 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 NCT05879367 about?

NCT05879367 is a clinical study titled "Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma". The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

What is the current status of trial NCT05879367?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2023-07-24. Estimated completion is 2026-06-30.

What conditions does trial NCT05879367 study?

This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, GBM, Astrocytoma, Glioblastoma, IDH-wildtype. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05879367?

The interventions under investigation include: Temozolomide (DRUG), Eflornithine (Dose Level 1) (DRUG), Eflornithine (Dose Level 2) (DRUG), Eflornithine (Dose Level -1) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05879367?

This trial is sponsored by Orbus Therapeutics, 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 NCT05879367 being conducted?

This trial has 8 study locations across Alabama, Michigan, New York, North Carolina, Ohio. 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