About this trial
The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Prior history of hypertensive encephalopathy at any time.
Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.
Contraindication to magnetic resonance imaging (MRI).
Local therapy (surgery and/or radiation therapy) is indicated per investigator
Trial design
Treatments tested in this trial
- Zanzalintinib
Treatment groups
Locations
12Sponsors and collaborators
Exelixis
Lead sponsor