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Recruiting Phase 2 NCT06926634

Zanzalintinib Maintenance in Patients With High Grade Neuroendocrine Neoplasms (HG-NENs)

Trial Parameters

Condition High Grade Neuroendocrine Neoplasms
Sponsor Washington University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 32
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-09
Completion 2034-12-31
Interventions
Zanzalintinib

Brief Summary

The investigators hypothesize that zanzalintinib maintenance therapy after initial cytotoxic chemotherapy can prolong the progression-free survival (PFS) in patients with high-grade NENs.

Eligibility Criteria

Inclusion Criteria: * Histologically or cytologically confirmed high-grade poorly differentiated or well differentiated neuroendocrine tumor (with a Ki-67 of ≥20%), excluding small cell lung cancer (SCLC) and Merkel cell cancer. High-grade includes any neuroendocrine neoplasm with a Ki-67 of \>20% or with mitotic count of more than 20 mitoses per high power field or any poorly differentiated neoplasm or any neoplasm lacking these that is deemed high grade by pathology consensus, based on other markers (necrosis or IHC demonstrating p53 or RB mutation). This includes: * High-grade well-differentiated neuroendocrine neoplasms * Transformed NENs from a lower to a higher grade (patient may have some low grade and some high grade NENs) * High-grade neoplasms with significant expression of neuroendocrine markers such as synaptophysin, chromogranin or INSM-1 or unknown origin neoplasms with gene expression signatures consistent with neuroendocrine lineage (as per validated tissue of origin te

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