Everolimus 5 mg vs 10 mg/Daily for Patients With 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 metastat

Trial Details

NCT ID
NCT06472388
Phase
PHASE2
Sponsor
AC Camargo Cancer Center
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Everolimus 5 MG
Locations (sample)
  • São Paulo, São Paulo, Brazil|-23.5475,-46.63611
  • São Paulo, Brazil|-23.5475,-46.63611

Key Eligibility 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).

For full eligibility, visit ClinicalTrials.gov.

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