Clinical trial · Interventional
Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
Randomized Phase II Trial of Everolimus 5 mg vs 10 mg/Daily for Patients With Advanced Neuroendocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumor Carcinoid | — | UNRESOLVED | — |
| Neuroendocrine Tumor Grade 1 | Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Neuroendocrine Tumor Grade 2 | Neuroendocrine Tumor G2 | ALIAS | 0.90 |
| Neuroendocrine Tumor of Pancreas | — | UNRESOLVED | — |
| Neuroendocrine Tumor of the Lung | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Progression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus 5 MG | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Everolimus 5
- description
- oral everolimus 5 mg/daily continuously until progression or intolerance or consent withdrawal. dose reduction for toxicity is allowed.
- interventionNames
- Drug: Everolimus 5 MG
- type
- ACTIVE_COMPARATOR
- label
- Everolimus 10
- description
- oral everolimus 10 mg/daily continuously until progression or intolerance or consent withdrawal. dose reduction for toxicity is allowed.
- interventionNames
- Drug: Everolimus 5 MG
Primary outcomes (1)
- measure
- Progression free survival rate at 12 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available