A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Summary
The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.
Arms & interventions
- DrugZanzalintinib
Administered as specified in the treatment arm.
Outcome measures
Primary
Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 12 months
Secondary
Progression-free Survival at 6 Months (PFS-6) per RANO as Assessed by BICR and Investigator
Time frame: Up to 6 months
Duration of Response (DOR) per RANO as Assessed by BICR and Investigator
Time frame: Up to approximately 48 months
Progression-free Survival (PFS) per RANO as Assessed by BICR and Investigator
Time frame: Up to approximately 48 months
Overall Survival (OS)
Time frame: Up to approximately 48 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 48 months
Change from Baseline in Neurologic Function as Measured by the Neurologic Assessment in Neuro-oncology (NANO) Scale Score
Time frame: Baseline up to approximately 13 months
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L) Score
Time frame: Baseline up to approximately 13 months
Eligibility criteria
Study locations (3)
Exelixis Site #3
Miami, Florida, 33176
Exelixis Site #2
Houston, Texas, 77030
Exelixis Site #1
San Antonio, Texas, 78229