Actively Recruiting
Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
Led by AC Camargo Cancer Center · Updated on 2024-06-25
100
Participants Needed
2
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of well-differentiated Grade 1 or Grade 2 neuroendocrine tumor from gastrointestinal, pancreatic, pulmonary, or unknown primary sites
- Metastatic or locally advanced and unresectable disease measurable by imaging
- Disease progression by RECIST 1.1 criteria within the last 6 months
- At least one previous line of systemic treatment, stopped for more than 3 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ function including hemoglobin > 8 g/dL, neutrophils 2,000/mm, platelets > 90,000/mm, AST and ALT 2.5 times upper limit of normal (ULN) or 5 times ULN if liver metastases present, bilirubin 1.5 times ULN, creatinine < 1.5 mg/dL
You will not qualify if you...
- Aggressive disease requiring cytotoxic chemotherapy
- Severe or uncontrolled comorbid conditions that make everolimus treatment unsafe
- Diagnosis of mixed neuroendocrine-non neuroendocrine neoplasm (MiNEN)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
AC Camargo Cancer Center
São Paulo, São Paulo, Brazil, 01509010
Actively Recruiting
2
AC Camargo Cancer Center
São Paulo, Brazil, 01509010
Actively Recruiting
Research Team
R
Rachel P Riechelmann, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here