Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors

Summary

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.

Eligibility

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

Conditions9

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