Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Orbus Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Protocol Defined Dose Limiting Toxicities
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2023-07-24 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT05879367 shows while recruiting
NCT05879367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (39% lower).
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 lists 8 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05879367's enrollment target sits among peer trials
66 67th of 199 higher than 132 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
RECRUITING · Phase 1
-
A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
RECRUITING · Phase 1
-
CARv3-TEAM-E T Cells in Glioblastoma
RECRUITING · Phase 1
-
CUE-102 in Recurrent Glioblastoma
RECRUITING · Phase 1
-
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
RECRUITING · Phase 1
-
Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02584244 · 66 participants · Phase 1
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
- NCT03067051 · 66 participants · Phase 1
Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
- NCT03754725 · 66 participants · Phase 1
Ferritin and Iron Burden in SAH sIRB
- NCT03875378 · 66 participants · Phase 2
Transdermal Estrogen in Women With Anorexia Nervosa
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI