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

Study acronym: EVENET
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 25, 2024 (before its estimated May 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06472388
Lead Sponsor AC Camargo Cancer Center
Conditions
(from sponsor)		 Neuroendocrine Tumors, Progression, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor of Pancreas, Neuroendocrine Tumor of the Lung, Neuroendocrine Tumor Carcinoid
Related terms Adenoma, Islet Cell, Carcinoid Tumor, Disease Progression, Neuroendocrine Tumors
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov