BridgeMD
Compares treatment options for Neuroendocrine Tumors
Official title Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
ClinicalTrials.gov ID: NCT06472388
What this study is testing
What is Everolimus 5 MG?
Everolimus 5 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for neuroendocrine tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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:
You likely can't join if
- Aggressive disease requiring cytotoxic therapy
- Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.
- MiNEN
See the full eligibility 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
- Aggressive disease requiring cytotoxic therapy
- Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.
- MiNEN
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil; São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.