Actively Recruiting
Phase 2 Study of Oral JZP3507 for Adults With Recurrent Grade 2 or 3 Meningioma After Previous Treatments
Led by Jazz Pharmaceuticals · Updated on 2026-07-30
30
Participants Needed
5
Research Sites
155 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the antitumor activity and safety of JZP3507 in adults with recurrent Grade 2 or 3 meningiomas who have not responded to previous treatments. This Phase 2 study focuses on participants with measurable progressive disease who are unable or have declined standard care options. The goal is to assess how well JZP3507 works and its tolerability in this patient group. Participants will receive oral doses of JZP3507 twice daily on three consecutive days each week in 28-day cycles. This treatment will continue as long as the participant benefits or until disease progression or unacceptable side effects occur. The study involves a single group receiving JZP3507 without a comparison group or placebo. During the study, participants will undergo regular imaging tests and laboratory assessments to monitor disease status and treatment effects. Researchers will measure response rates using the Response Assessment in Neuro-Oncology criteria and track safety by recording adverse events and pharmacokinetic data over up to 36 months. Participants will be followed up for progression-free survival, overall survival, and treatment tolerability throughout the study period.
CONDITIONS
Brief Title
A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma
Research Team
C
Clinical Trial Disclosures & Transparency
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