A Phase II trial to Evaluate the Efficacy and Safety of
OKN-007 Combined with Temozolomide (TMZ)
in Patients with Recurrent Glioblastoma
Key Inclusion Criteria:
- Confirmed recurrent GBM, following primary treatment with TMZ and radiotherapy (at least two cycles of maintenance TMZ) : Patients with an initial diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined to be GBM and the patient received prior radiochemotherapy
- Patients must be ≥18 years of age
Key Exclusion Criteria:
- Early discontinuation of TMZ in first line due to treatment related adverse events
- Patients receiving or planning to initiate treatment with the tumor treating fields device, Optune®
(Optune® treatment prior to enrollment is permitted)
For your participation in the study, contact Oblato or the nearest institution below:
For your participation in the study, contact Oblato or the nearest institution below:
Sponsor, Oblato
Contact: Alex E. Kim, Project Manager 609-734-4329 Alex@oblatoinc.com
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Contact: Thiru Pillay 205-934-1432 tpillay@uabmc.edu
Sub-Investigator: Louis Burt Nabors, MD
United States, Arizona
St. Joseph’s Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Contact: Katy Gilbert Kathryn.Gilbert@DignityHealth.org
Principal Investigator: Ekokobe Fonkem, DO
United States, California
Providence Saint John’s Health Center – John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Contact: Ashley Archer 310-582-7460 Ashley.Archer@providence.org
Principal Investigator: Santosh Kesari, MD, PhD
Sub-Investigator: Naveed Wagle, MD
United States, Colorado
Swedish Medical Center
Englewood, Colorado, United States, 80113
Contact: Judith Stucky Judith.Stucky@HCAhealthcare.com
Principal Investigator: Michael Pearlman, MD
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Contact: Stephanie Mintoff Smintof1@hfhs.org
Principal Investigator: Tobias Walbert, MD, PhD
United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Contact: Ashley Carroll arcarrol@wakehealth.edu
Principal Investigator: Glenn Lesser, MD
United States, Ohio
The University of Toledo
Toledo, Ohio, United States, 43606
Contact: Stephanie Smiddy stephanie.smiddy@utoledo.edu
Principal Investigator: Roland Skeel, MD
United States, Oklahoma
The University of Oklahoma
Oklahoma City, Oklahoma, United States, 73117
Contact: Hee Sun Kim-Suh HeeSun-Kim@ouhsc.edu
Principal Investigator: James Battiste, MD, PhD