NCT06472388RecruitingPhase 2
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 · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 3 May 2024
- Start date
- 24 Apr 2024
- Primary completion date
- 20 May 2026
- Lead sponsor
- AC Camargo Cancer Center
- NCT number
- NCT06472388
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 24 Apr 2024 to the primary completion date, 20 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Aggressive disease requiring cytotoxic therapy
- Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.
Other
- MiNEN
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AC Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.