A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma
ConditionMeningioma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals
About this trial
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 criteria
Qualifiers
Is ≥ 18 years of age at the time of signing the informed consent.
Has histologically confirmed Grade 2 or 3 meningioma.
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.
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 enrollment.
Disqualifiers
Has known hypersensitivity to JZP3507, dordaviprone, or any excipient used in the JZP3507 study intervention formulation.
Has active cardiac disease/condition as defined in the protocol.
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Exceptions include participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Has an active infection that requires systemic therapy.
Trial design
Treatments tested in this trial
- JZP3507
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Jazz Pharmaceuticals
Lead sponsor
Chimerix, Inc.
Collaborator
Source ClinicalTrials.gov