NCT05879367 Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
| NCT ID | NCT05879367 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Orbus Therapeutics, Inc. |
| Condition | Glioblastoma, IDH-wildtype |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2023-07-24 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2023-07-24 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) per WHO 2021 tumor classification. * Completed external beam radiation therapy per standard of care. * Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles. * Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing. * Willing to abstain from intercourse or use acceptable contraceptive methods. * If taking corticosteroids, must be on a stable or decreasing dose. Exclusion Criteria: * Recent history of recurrent or metastatic cancer that could confound response assessments * Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma). * Prior Optune treatment. * Active infection or serious intercurrent medical illness. * Poorly controlled seizures. * Significant cardiac disease within 6 months of enrollment. * Poorly controlled diabetes. * Use of another investigational agent within 30 days of enrollment.
Contact & Investigator
Howard Colman, MD, PhD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute/ University of Utah
Frequently Asked Questions
Who can join the NCT05879367 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma, IDH-wildtype. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05879367 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05879367 currently recruiting?
Yes, NCT05879367 is actively recruiting participants. Contact the research team at monika.varga@orbustherapeutics.com for enrollment information.
Where is the NCT05879367 trial being conducted?
This trial is being conducted at Birmingham, United States, Detroit, United States, New York, United States, Durham, United States and 4 additional locations.
Who is sponsoring the NCT05879367 clinical trial?
NCT05879367 is sponsored by Orbus Therapeutics, Inc.. The principal investigator is Howard Colman, MD, PhD at Huntsman Cancer Institute/ University of Utah. The trial plans to enroll 66 participants.
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