A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Sponsor: Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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 Endpoints
Progression-free Survival at 6 Months (PFS-6) per RANO as Assessed by BICR and Investigator
Duration of Response (DOR) per RANO as Assessed by BICR and Investigator
Progression-free Survival (PFS) per RANO as Assessed by BICR and Investigator
Eligibility Criteria
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%. *…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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