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

Inclusion Criteria10

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).
Eastern Cooperative Oncology Group (ECOG) 0-2 o Good organ function:
Hemoglobin \> 8 g/dL
Neutrophils ≥ 1,500/mm³
Platelets \> 90,000/mm³
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN \[upper limit of normal\] or ≤ 5 x ULN for patients with liver metastases
Bilirubin ≤ 1.5 x ULN, creatinine \< 1.5 mg/dL

Exclusion Criteria3

Aggressive disease requiring cytotoxic therapy
Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.
MiNEN