RecruitingPhase 2NCT06472388

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

Randomized Phase II Trial of Everolimus 5 mg vs 10 mg/Daily for Patients With Advanced Neuroendocrine Tumors

Sponsor

AC Camargo Cancer Center

Enrollment

100 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

Neuroendocrine Tumors Progression Neuroendocrine Tumor of Pancreas Neuroendocrine Tumor Grade 1 Neuroendocrine Tumor Grade 2 Neuroendocrine Tumor of the Lung Neuroendocrine Tumor Carcinoid

Summary

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.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two doses of everolimus (5 mg vs 10 mg daily) in people with slow-growing neuroendocrine tumors (NETs) — cancers that arise from hormone-producing cells in organs like the pancreas, gut, or lungs — to find the dose that is most effective with fewer side effects. **You may be eligible if...** - You have a confirmed well-differentiated Grade 1 or Grade 2 neuroendocrine tumor from the gastrointestinal tract, pancreas, lung, or an unknown primary site - Your cancer has spread or is locally advanced and cannot be surgically removed - Your disease has progressed in the last 6 months (confirmed by imaging) - You have received at least one previous line of treatment - Your ECOG score is 0 to 2 and your organ function meets required levels **You may NOT be eligible if...** - Your tumor is high-grade or poorly differentiated - You have not had any prior systemic treatment - You have serious kidney, liver, or blood count problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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