Comparing two doses of Everolimus for treating neuroendocrine tumors
Randomized Phase II Trial of Everolimus 5 mg vs 10 mg/Daily for Patients With Advanced Neuroendocrine Tumors
This study is testing whether a lower dose of Everolimus can effectively treat patients with advanced neuroendocrine tumors while causing fewer side effects compared to a higher dose.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | AC Camargo Cancer Center Academic / other |
| Locations | 2 sites (São Paulo, São Paulo and 1 other locations) |
| Trial ID | NCT06472388 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of two different doses of Everolimus (5 mg vs 10 mg daily) in patients with Grade 1 or Grade 2 metastatic neuroendocrine tumors (NET) who have experienced disease progression. The study is randomized and open-label, focusing on comparing progression-free survival, time to treatment failure, and the frequency of adverse effects between the two dosing regimens. The rationale for this trial stems from previous findings suggesting that the lower dose may provide similar antitumor effects with reduced toxicity. Participants will be monitored for radiological responses and tolerability using established criteria.
Who should consider this trial
Good fit: Ideal candidates include individuals with well-differentiated Grade 1 or Grade 2 metastatic neuroendocrine tumors who have experienced disease progression after at least one prior treatment.
Not a fit: Patients with aggressive neuroendocrine tumors requiring cytotoxic therapy or those with severe uncontrolled comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment option for patients with advanced neuroendocrine tumors while maintaining effectiveness.
How similar studies have performed: Previous studies have indicated that lower doses of Everolimus may be effective, suggesting potential success for this approach, although this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo, São Paulo and 1 other locations
- AC Camargo Cancer Center — São Paulo, São Paulo, Brazil (Recruiting)
- AC Camargo Cancer Center — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Rachel P Riechelmann, MD
- Email: rachel.riechelmann@accamargo.org.br
- Phone: +55112189500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.