Title
A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

Description
A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

Objective
Primary: To evaluate efficacy of zanzalintinib in participants with recurrent or progressive meningioma
Secondary: To further evaluate efficacy of zanzalintinib in participants with recurrent or progressive meningioma
To evaluate safety and tolerability of zanzalintinib in participants with recurrent or progressive meningioma
To assess the impact on neurological function
To evaluate quality of life in participants with recurrent or progressive meningioma

Treatment The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.

Key Eligibility Key Inclusion Criteria:

-Histologically confirmed World Health Organization (WHO) grade 1, 2, or 3 meningioma.
-Developed recurrent disease or progressive disease (PD) after receiving standard therapy (for example, surgery and/or radiation) or have been deemed ineligible to receive these therapies. At least 1 prior course of meningioma-directed radiotherapy is required, if not contraindicated.
-Radiologically documented progression of any existing tumor (growth > 15% of the bidimensional enhancing tumor within the prior 6 months or appearance of new lesions (including intra and extracranial manifestations).
-For participants treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval >/=24 weeks must have elapsed from completion of therapy to initiation of treatment.
-Measurable disease by RANO meningioma criteria as determined by the investigator, obtained ≤ 14 days prior to initiation of treatment.
-Karnofsky performance status (KPS) >/=60%.
-Demonstrate adequate organ and marrow function within 14 days of treatment initiation

Applicable Disease Sites
Brain/Central Nervous System

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital