NCT06472388
Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
Recruiting · Phase 2 · AC Camargo Cancer Center · registry updated 2024-06-25
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
Exclusion
- Aggressive disease requiring cytotoxic therapy
- Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.