OncoMatch/Clinical Trials/NCT05879367
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Is NCT05879367 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Eflornithine (Dose Level 1) and Eflornithine (Dose Level 2) for glioblastoma, idh-wildtype.
Treatment: Eflornithine (Dose Level 1) · Eflornithine (Dose Level 2) · Eflornithine (Dose Level -1) · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: CDKN2A intact
Required: CDKN2B intact
Required: IDH1 mutation
Required: IDH1 wild-type
Required: IDH2 mutation
Required: IDH2 wild-type
Disease stage
Grade: G4 (GBM), G3 (astrocytoma) (WHO)
WHO G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) per WHO 2021 tumor classification
Prior therapy
Must have received: radiation therapy — external beam
Completed external beam radiation therapy per standard of care
Must have received: alkylating agent (temozolomide) — chemoradiation (GBM)
Must have received at least 80% of planned daily doses of TMZ during chemoradiation (GBM)
Must have received: alkylating agent (temozolomide) — adjuvant (astrocytoma)
Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles (astrocytoma)
Cannot have received: systemic chemotherapy
Exception: other than temozolomide during external beam radiation therapy (GBM) or adjuvant temozolomide through up to 4 pre-study cycles (astrocytoma)
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)
Cannot have received: tumor treating fields (Optune)
Prior Optune treatment
Lab requirements
Blood counts
adequate hematologic function as indicated by hematology testing
Kidney function
adequate renal function as indicated by serum chemistry testing
Liver function
adequate hepatic function as indicated by serum chemistry testing
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Henry Ford Hospital · Detroit, Michigan
- Columbia University Medical Center - Herbert Irving Pavilion · New York, New York
- Duke University · Durham, North Carolina
- The Cleveland Clinic · Cleveland, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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