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Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Sponsor: Orbus Therapeutics, Inc.
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.
Official title: An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2023-07-24
Completion Date
2026-06-30
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
Eflornithine (Dose Level 1)
Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
Eflornithine (Dose Level 2)
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
Eflornithine (Dose Level -1)
Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
Temozolomide
Temozolomide 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
Locations (8)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Henry Ford Hospital
Detroit, Michigan, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
Duke University
Durham, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Brown University Health/Rhode Island Hospital
Providence, Rhode Island, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States