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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with advanced, well-differentiated Grade 1 or Grade 2 neuroendocrine tumors that have spread or cannot be removed, and that have grown in the last 6 months. It compares everolimus 5 mg with 10 mg daily.
- Age
- 16 years or older
- Sex
- All sexes can join
- Disease stage
- Well-differentiated Grade 1 or Grade 2 neuroendocrine tumor (NET) of the gut, pancreas, lung or unknown primary site. The disease has spread or cannot be removed by surgery, can be measured on scans, and has grown by RECIST 1.1 in the last 6 months.
- Earlier treatment
- At least one earlier line of treatment for the whole body, stopped more than 3 weeks ago.
Main reasons for not taking part
- Aggressive disease that needs chemotherapy
- Severe or uncontrolled other illnesses that make everolimus unsafe, in the investigators' judgement
- MiNEN (mixed neuroendocrine-non-neuroendocrine neoplasm)
Read by machine on 12 November 2026.
Where in Brazil
- AC Camargo Cancer CenterSão Paulo, BrazilContact: Rachel P Riechelmann, MDTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.