Compares everolimus 5 mg and 10 mg daily in advanced neuroendocrine tumors
Compares everolimus 5 mg with 10 mg daily in people with neuroendocrine tumors.
Plain-language title generated from the registry record
Registry title: Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 2
Where in Brazil
- AC Camargo Cancer CenterSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AC Camargo Cancer Center
- Trial code
- NCT06472388
- Record updated
- 25 June 2024
- Original description
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.Read full original descriptionShow less
Randomized Phase II Trial of Everolimus 5 mg vs 10 mg/Daily for Patients With Advanced Neuroendocrine Tumors
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.
Inclusion: 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: Aggressive disease requiring cytotoxic therapy; Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement; MiNEN.