A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma
ConditionMeningioma
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
JZP3507
DrugParticipants will receive oral JZP3507 monotherapy twice daily, on 3 consecutive days per week in 28-day cycles.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: JZP3507 (ONC206)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria and Evaluated by Blinded Independent Central Review (BICR)
ORR is the best response of confirmed complete response (CR), partial response (PR), or minor response (MR) during the study, as per RANO criteria
Time frame
From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.Secondary outcomes
1
Duration of Response (DOR)
DOR is the time from the first objective response (CR, PR, or MR) that is subsequently confirmed to documented progressive disease (PD) per RANO criteria or death from any cause.
Time frame
From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.2
Time to Response (TTR)
TTR is the time from the first dose of the study intervention to the first objective response (CR, MR, or PR) subsequently confirmed per RANO criteria.
Time frame
From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.3
Disease Control Rate (DCR)
Proportion of participants who achieved disease control in the study.
Time frame
From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.4
Progression-Free Survival (PFS)
PFS is the time from the first dose of study intervention to the date of first documented PD per RANO criteria (evaluated by BICR) or death from any cause, whichever occurs first.
Time frame
From first dose to date of documented disease progression or death, up to 36 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jazz Pharmaceuticals
Lead sponsor
Chimerix, Inc.
Collaborator
Source ClinicalTrials.gov