A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma
Status:
Withdrawn
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This is an open-label, two arm study. The trial will enroll a total of up to 36 patients. Arm
A will enroll up to a total of 6 evaluable patients and Arm B will enroll up to a total of 30
evaluable patients. Arm A will explore the intra-tumoral ONC201 concentrations and
pharmacodynamic activity in adult EGFR-low glioblastoma patients. Arm B will determine the
radiographic efficacy of ONC201 in adult recurrent EGFR-low glioblastoma patients. All
patients will be treated with oral ONC201 (625 mg) twice weekly, 2 consecutive days on and 5
days off per week schedule.