Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three different dose levels. Phase 2a of the study, will further evaluate the safety, tolerability, and in addition efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
University of California, Los Angeles
Los Angeles, California, United States
RECRUITINGNorthwestern University Feinberg School of Medicine
Chicago, Illinois, United States
RECRUITINGHenry Ford Health Systems
Detroit, Michigan, United States
Phase 1b: Evaluation of the safety and tolerability of AQ4N in combination with radiation therapy and temozolomide (TEMODAR®)for the treatment of glioblastoma multiforme (GBM). Dose levels for the Phase 2a will be selected.
Phase 2a: Rate of progression-free survival at 6 months.
Phase 2a: Rate of progression-free survival at 12 months
Percent of subjects alive at 12 months
Duration of progression-free survival
Time to progression
Duration of overall survival
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Duke University Medical Center
Durham, North Carolina, United States
RECRUITINGBaylor Research Institute
Dallas, Texas, United States
RECRUITING