66
Participants
Start Date
July 24, 2023
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2026
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
RECRUITING
Columbia University Medical Center - Herbert Irving Pavilion, New York
RECRUITING
Duke University, Durham
WITHDRAWN
University of Alabama at Birmingham, Birmingham
RECRUITING
The Cleveland Clinic, Cleveland
RECRUITING
Henry Ford Hospital, Detroit
RECRUITING
UT MD Anderson Cancer Center, Houston
RECRUITING
University of Utah, Huntsman Cancer Institute, Salt Lake City
RECRUITING
Brown University Health/Rhode Island Hospital, Providence
Lead Sponsor
Orbus Therapeutics, Inc.
INDUSTRY