Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Recruiting now · Phase 1
Conditions studied: Glioblastoma, IDH-wildtype, Glioblastoma, Glioblastoma Multiforme, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, GBM, Astrocytoma, Astrocytoma, IDH-Mutant
In brief
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.
Key facts
- Study ID
- NCT05879367
- Run by
- Orbus Therapeutics, Inc.
- People needed
- 66
- Starts
- 2023-07-24
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
- Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
- Columbia University Medical Center - Herbert Irving Pavilion — New York, New York, United States (enrolling)
- Duke University — Durham, North Carolina, United States (enrolling)
- The Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Brown University Health/Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
- UT MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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