Spots Global Cancer Trial Database for A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma
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Trial Identification
Brief Title: A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma
Official Title: A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma
Study ID: NCT04629209
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Minnesota, Minneapolis, Minnesota, United States
Contact Details
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