OncoMatch

OncoMatch/Clinical Trials/NCT06472388

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

Is NCT06472388 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Everolimus 5 MG for neuroendocrine tumors.

Phase 2RecruitingAC Camargo Cancer CenterNCT06472388Data as of May 2026

Treatment: Everolimus 5 MGEverolimus 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.

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Extracted eligibility criteria

Cancer type

Neuroendocrine Tumor

Disease stage

Grade: 12

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received:

At least one previous line of systemic treatment (suspended for more than 3 weeks).

Lab requirements

Blood counts

hemoglobin > 8 g/dl; neutrophils ≥ 1,500/mm³; platelets > 90,000/mm³

Kidney function

creatinine < 1.5 mg/dl

Liver function

ast and alt ≤ 2.5 x uln or ≤ 5 x uln for patients with liver metastases; bilirubin ≤ 1.5 x uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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