Comparing two doses of Everolimus for treating neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating the impact of somatostatin analogues on tumor dose during radionuclide therapy

  This study is testing if stopping or continuing long-acting somatostatin treatment affects how well radionuclide therapy works for adults with neuroendocrine tumors.

  Recruiting Phase 2/3 The Netherlands Cancer Institute · Amsterdam · NCT06855095

• Customized Lutetium-177 treatment for neuroendocrine tumors

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  Recruiting Phase 2 University of Iowa · Iowa City, Iowa · NCT06395402

• Exploring new biomarkers for diagnosing and treating neuroendocrine tumors

  This study is testing new ways to diagnose and treat neuroendocrine tumors by looking at blood samples to see if they can provide better information about the cancer.

  Recruiting University of Roma La Sapienza · Rome, Italy · NCT04464122

• Combination therapy for Grade 2 liver-dominant neuroendocrine tumors

  This study is testing a new combination treatment of two drugs followed by a special radiation therapy to see if it helps people with Grade 2 liver-dominant neuroendocrine tumors live longer without their cancer getting worse.

  Recruiting Phase 2 Abramson Cancer Center at Penn Medicine · La Jolla, California and 4 other locations · NCT04339036

• New DLL3 PET/CT imaging for neuroendocrine tumors compared with standard scans

  A new PET/CT scan using the 68Ga-DLL3 nanobody is being tested to see if it detects metastatic neuroendocrine tumors better than current scans in adults.

  Recruiting at 2 sites Phase 2 Peking University First Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07733024

• CTX-471 for NCAM-positive metastatic neuroendocrine tumors

  A phase 2 trial is testing CTX-471 in adults with NCAM (CD56) positive metastatic neuroendocrine tumors that have progressed after standard therapy.

  Recruiting at 2 sites Phase 2 Compass Therapeutics · St Louis, Missouri and 1 other locations · NCT07684170

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.