Purpose of this Study
In this study, people will take a study medicine called JZP 3507 by mouth as tablets. They will take the medicine twice a day for three days in a row each week. This pattern repeats in cycles that last 28 days.
The study has several parts, including a screening period to see if someone can join, a treatment period, a safety follow up, and a long term follow up that can last up to three years. The whole study may last about four years and includes many study visits.
During the study, participants will have regular checkups such as physical exams, blood and urine tests, heart tests, and scans like MRI. Everyone in the study will receive the study medicine, and both the participant and the doctor will know what treatment is being given.
Who Can Participate?
Eligibility
People may be able to join this study if they are 18 years old or older and have a type of brain tumor called meningioma that has come back and is getting worse. The tumor must be one that doctors can measure on scans. Participants must be able to swallow pills. They cannot have taken the study medicine before. They also cannot have certain types of meningioma that affect the optic nerve, grow outside the brain, or are mainly in the spinal cord.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new medicine called JZP 3507 for people who have a type of brain tumor called meningioma. Researchers want to see if the medicine is safe and how it works in the body. They will also look at how people feel while taking it. The goal is to learn if this medicine can slow down or stop the tumor from growing.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 2 study to investigate efficacy, safety, tolerability, and pharmacokinetics of JZP3507 (ONC206) in adults with recurrent Grade 2 or 3 meningioma
Principal Investigator
Margaret
Johnson
Protocol Number
PRO00120456
NCT ID
NCT07533942
Phase
II
Enrollment Status
Pending Open to Enrollment