drugset / Trial / NCT04629209
A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-06-28
- Primary completion
- 2024-12-31
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dordaviprone | Small molecule | 625 mg | Oral |