NCT04629209

A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	ONC201	ONC201 is a orally active, small molecule DRD2 antagonist that kills cancer cells but not normal cells.

Timeline

• Start date: 2024-06-28
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2020-11-16
• Last updated: 2023-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study