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.
Histological confirmation of well-differentiated Grade 1/Grade 2 NET from gastrointestinal, pancreatic, pulmonary or unknown primary sites.
Metastatic or locally advanced and unresectable disease, measurable by images
Disease progression by RECIST 1.1 in the last 6 months assessed by local investigators
At least one previous line of systemic treatment (suspended for more than 3 weeks).
Aggressive disease requiring cytotoxic therapy
Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.
MiNEN
Parallel
Everolimus 5 MG
Drugoral everolimus 5 mg/daily
Progression free survival rate at 12 months
Proportion of patients without radiological progression or death at 12 months from first day of everolimus
progression free survival
Time from first day of everolimus until radiological progression or death (time to event)
time to treatment failure
fTime from first day of everolimus until progression, treatment discontinuation for toxicity or death
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