NCT06472388 Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
| NCT ID | NCT06472388 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AC Camargo Cancer Center |
| Condition | Neuroendocrine Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2026-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-04-24 with a primary completion date of 2026-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06472388 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Neuroendocrine Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06472388 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06472388 currently recruiting?
Yes, NCT06472388 is actively recruiting participants. Contact the research team at rachel.riechelmann@accamargo.org.br for enrollment information.
Where is the NCT06472388 trial being conducted?
This trial is being conducted at São Paulo, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT06472388 clinical trial?
NCT06472388 is sponsored by AC Camargo Cancer Center. The trial plans to enroll 100 participants.