A Phase 2 Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP3507 (ONC206) in Adults With Recurrent Grade 2 or 3 Meningioma
Jazz Pharmaceuticals
Summary
This study will recruit participants with Grade 2 and 3 meningiomas who have failed prior therapy. Participants will receive oral doses of JZP3507. The antitumor activity and safety of JZP3507 will be evaluated.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: Age 1. Is ≥ 18 years of age at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Has histologically confirmed Grade 2 or 3 meningioma. 3. Has failed, is not a candidate for, or has declined standard of care treatment for meningioma. Note: There is no limit on the number of prior systemic therapies. 4. Has measurable disease, as assessed by the investigator. Measurable disease is defined as at least one lesion measuring ≥ 10 mm on perpendicular dimensions by contrast-enhanced MRI performed within 28 days prior to study enr…
Interventions
- DrugJZP3507
Participants will receive oral JZP3507 monotherapy twice daily, on 3 consecutive days per week in 28-day cycles.
Locations (5)
- Sutter HealthSan Francisco, California
- Louisiana State UniversityNew Orleans, Louisiana
- Mass GeneralBoston, Massachusetts
- NYU- Langone HealthNew York, New York
- University of Utah - Huntsman Cancer InstituteSalt Lake City, Utah