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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will receive oral JZP3507 monotherapy twice daily, on 3 consecutive days per week in 28-day cycles.
Sutter Health
San Francisco, California, United States
Louisiana State University
New Orleans, Louisiana, United States
Mass General
Boston, Massachusetts, United States
NYU- Langone Health
New York, New York, United States
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 40 months.
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 64 months.
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 64 months.
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 64 months.
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 64 months.
Overall Survival (OS)
OS is the time from the first dose of the study intervention to death from any cause.
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University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Time frame: From first dose until death, or up to 64 months.
Incidence of Grade 3 or higher Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 64 months.
Number of Adverse Events (AEs) Resulting in Study Discontinuation
Time frame: Up to 64 months.
Maximum Observed Plasma Concentration (Cmax) of JZP3507
Time frame: Up to 64 months.
Time of Maximum Observed Plasma Concentration (Tmax) of JZP3507
Time frame: Up to 64 months.
Area Under the Concentration-Time Curve Over a Time interval (AUC(0-τ)) of JZP3507
Time frame: Up to 64 months.
Terminal Elimination Half-life ( t½) of JZP3507
Time frame: Up to 64 months.
Apparent Oral Clearance (CL/F)
Time frame: Up to 64 months.
Apparent Volume of Distribution After Oral Dose (Vz/F)
Time frame: Up to 64 months.