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Brief Title: Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
Official Title: A Phase II Open-label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
Study ID: NCT04388475
Brief Summary: This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease. Patients with unequivocal recurrence (first or greater) established by MRI and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Providence Saint John's Health Center - John Wayne Cancer Institute, Santa Monica, California, United States
Swedish Medical Center, Englewood, Colorado, United States
AdventHealth Orlando, Orlando, Florida, United States
University of Iowa, Iowa City, Iowa, United States
Norton Healthcare, Louisville, Kentucky, United States
Henry Ford Health System, Detroit, Michigan, United States
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
The University of Toledo, Toledo, Ohio, United States
The University of Oklahoma, Oklahoma City, Oklahoma, United States
Lifespan Office of Research, Providence, Rhode Island, United States
St. Joseph Hospital of Orange, Seattle, Washington, United States