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NCT05879367
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Phase 1 trial testing Eflornithine (Dose Level 1) in Glioblastoma, IDH-wildtype in 66 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Orbus Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 24 July 2023 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Eflornithine (Dose Level 1)
- Eflornithine (Dose Level 2) — full drug profile →
- Eflornithine (Dose Level -1) — full drug profile →
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Glioblastoma, IDH-wildtype — all drugs for Glioblastoma, IDH-wildtype →
- Glioblastoma — all drugs for Glioblastoma →
- Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype — all drugs for Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype →
Sponsor
Orbus Therapeutics, Inc. — full company profile →
Who can join
18 and older, any sex, with Glioblastoma, IDH-wildtype or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Polyamines: the pivotal amines in influencing the tumor microenvironment.
Holbert CE, Casero RA, Stewart TM. · · 2024 · cited 27× · PMID 38761252 · DOI 10.1007/s12672-024-01034-9 -
Management of Low-Grade Gliomas.
Diaz M, Pan PC. · · 2025 · cited 5× · PMID 39841424 · DOI 10.1097/ppo.0000000000000760
Verify or expand the search:
- PubMed search for NCT05879367
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Glioblastoma, IDH-wildtype
Currently open trials in the same condition.
- NCT06419946 — Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma · Phase 3 · recruiting
- NCT06327451 — Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma · Phase 2 · recruiting
- NCT06418113 — Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma · Phase 1 · recruiting
- NCT05941234 — Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma · NA · recruiting
- NCT05929495 — Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05879367 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Orbus Therapeutics, Inc.
- Last refreshed: 25 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05879367.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing