NCT06012929

A Study of ONC201 for Refractory Meningioma

A Pilot Study, Open-Label Study of ONC201 for Refractory Meningioma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about treatment for a type of brain tumor called a meningioma. This study will enroll two groups of people. One group will be for people who will receive surgery to remove their brain tumor. The other group will be for people who have previously received treatment for their brain tumor but do not have any other available options for treatment. The primary goals of this study are: 1. To measure how much of the study drug is present in tumor tissue taken from patients during surgery to remove their brain tumor 2. To measure the length of time between a study participant's first dose of study treatment until the time when their brain tumor gets worse or their death

Detailed description

Patients will be enrolled in one of two arms, either the presurgical arm or the treatment arm. Patients who will be undergoing surgery to remove their meningioma will be enrolled to Arm I. Patients who have previously received treatment for their meningioma but have exhausted all reasonable treatment options will be enrolled to Arm II. All patients will take the study medication, ONC201, by mouth once per week at a dose of 625 mg. * Arm I patients will receive two doses of ONC201 prior to surgery, with the second dose occurring approximately 24 hours before surgery. * Arm II patients will receive one 625 mg dose of ONC201 per week until disease progression or intolerable toxicity. Primary Objectives 1. To evaluate the concentration of ONC201 in resected meningioma tissue (Arm I) 2. To measure progression-free survival in patients receiving ONC201 who have exhausted all other reasonable treatment options (Arm II) Secondary Objectives 1. To evaluate tumor response via radiographic imaging following treatment with ONC201 2. To correlate dopamine receptor D2 (DRD2) expression with tumor response to treatment via molecular studies performed on archival and fresh tissue 3. To determine overall survival 4. To determine the efficacy of adding bevacizumab to ONC201 in patients who have progressed on ONC201 alone

Conditions

• Meningioma
• Refractory Meningioma
• Relapsed Meningioma

Interventions

Type	Name	Description
DRUG	ONC201	ONC201 is an oral medication given once per week

Timeline

• Start date: 2026-12-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2023-08-28
• Last updated: 2026-01-26

Regulatory

• FDA-regulated drug study