Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
Recruiting · NCT06472388 · Interventional (participants receive a specific treatment) · Lead sponsor: AC Camargo Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Aggressive disease requiring cytotoxic therapy
- Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.
- MiNEN
Where it is running
2 locations listed.
- AC Camargo Cancer Center - São Paulo, Brazil
- AC Camargo Cancer Center - São Paulo, São Paulo, Brazil