Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors

Everolimus is approved in many countries to treat patients with advanced/metastatic well-differentiated neuroendocrine tumors (NET), providing median progression-free survival times of approximately 12 months across different types of NET. However, it is can cause severe adverse effects. Phase I trial demonstrated that a dose of 5mg/day/week was sufficient to inhibit cell proliferation by blocking the mTOR pathway. This is a randomized, open-label, phase II near-equivalence clinical trial of oral everolimus 5 mg vs 10 mg oral/daily and continuously in patients with Grade 1 or Grade 2 metastatic NET, with tumor progression or intolerance to at least one line of treatment and with radiological disease progression within 6 months.

NCT Number	NCT06472388
Lead Sponsor	AC Camargo Cancer Center
Conditions	Neuroendocrine Tumors, Progression, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor of Pancreas, Neuroendocrine Tumor of the Lung, Neuroendocrine Tumor Carcinoid
Enrollment	100 participants
Start Date	2024-04-24
Primary Completion	2026-05-20 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-06-25