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NCT05879367 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Orbus Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
66
Enrollment target
8
Study locations

NCT05879367 is a Phase 1 study of Glioblastoma and Glioblastoma Multiforme that is actively recruiting participants, run by Orbus Therapeutics. The registered enrollment target is 66 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (39% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT05879367, a Phase 1 study of Glioblastoma and Glioblastoma Multiforme, is actively recruiting participants, sponsored by Orbus Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
66 participants
Enrollment target
8
Study locations

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.

Conditions Studied

Glioblastoma Glioblastoma Multiforme GBM Astrocytoma Glioblastoma, IDH-wildtype Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype Astrocytoma, IDH-Mutant

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, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (39% lower). The listed sponsor is Orbus Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT05879367 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Alabama, Michigan, New York.

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.

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).

Who is sponsoring clinical trial NCT05879367?

This trial is sponsored by Orbus Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.