57
Participants
Start Date
June 12, 2020
Primary Completion Date
May 8, 2024
Study Completion Date
March 5, 2025
OKN-007
Drug: OKN-007 (400 mg OKN-007/mL in a phosphate buffer) Administered via IV infusion, at a dose level of 60 mg/kg, given three times a week for 12 weeks, two times a week for a further 12 weeks and once per week until disease progression or up to two years.
Temozolomide (TMZ)
Administered via oral, at a dose level of 150 mg/m2, once daily on Days 1-5 of each 28 day cycle in Cycle 1. If this dose level is tolerated, then in Cycle 2 (and subsequent cycles), at a dose level of 200 mg/m2, once daily on Days 1-5 of each 28 day cycle.
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem
AdventHealth Orlando, Orlando
St. Joseph Hospital of Orange, Seattle
University of Alabama at Birmingham, Birmingham
Norton Healthcare, Louisville
The University of Toledo, Toledo
Henry Ford Health System, Detroit
University of Iowa, Iowa City
The University of Oklahoma, Oklahoma City
Swedish Medical Center, Englewood
St. Joseph's Hospital and Medical Center, Phoenix
Providence Saint John's Health Center - John Wayne Cancer Institute, Santa Monica
Lifespan Office of Research, Providence
Oblato, Inc.
INDUSTRY