Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Orbus Therapeutics, Inc.
- Study ID
- NCT05879367
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Astrocytoma
- Astrocytoma, IDH-Mutant
- GBM
- Glioblastoma
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
- Glioblastoma Multiforme
- Glioblastoma, IDH-wildtype
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Eflornithine (Dose Level 1) — DRUGEflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
- Eflornithine (Dose Level 2) — DRUGEflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
- Eflornithine (Dose Level -1) — DRUGEflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
- Temozolomide — DRUGTemozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule
Study Details
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 Dates
- Start date
- Jul 24, 2023
- Status verified
- Jun 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 66 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Eflornithine Dose Level 1 + Temozolomide
- Experimental: Eflornithine Dose Level 2 + Temozolomide
- Experimental: Eflornithine Dose Level -1 + Temozolomide
Primary Outcome Measure
Assessment of Dose Limiting Toxicities [ Time Frame: 8 weeks ]
Central Contacts
- Monika Varga6506569424
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | - |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Tobias Walbert, MD, PhD, MPH (PRINCIPAL_INVESTIGATOR) |
| Columbia University Medical Center - Herbert Irving Pavilion | New York | New York | 10032 | Maria Diaz, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University | Durham | North Carolina | 27710 | Annick Desjardins, MD, FRCPC (PRINCIPAL_INVESTIGATOR) |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | Rachel Hufsey, RN David Peereboom, MD (PRINCIPAL_INVESTIGATOR) |
| Brown University Health/Rhode Island Hospital | Providence | Rhode Island | 02903 | Eric Wong, MD (PRINCIPAL_INVESTIGATOR) |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | Carlos Kamiya Matsuoka, MD (PRINCIPAL_INVESTIGATOR) |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | Howard Colman, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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