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Study of Cabozantinib in Adults with Advanced Low-Grade Neuroendocrine Tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates the use of Cabozantinib (also known as XL-184) in patients with advanced Neuroendocrine Neoplasia, specifically a subtype called NEN G3. Neuroendocrine neoplasia is a type of cancer that begins in specialized cells called neuroendocrine cells, which have traits similar to those of nerve cells and hormone-producing cells.

The study aims to evaluate how well Cabozantinib works in treating this type of cancer. The medication comes in the form of film-coated tablets that are taken by mouth and is available in three different strengths: 20 mg, 40 mg, and 60 mg. The treatment period may last up to 27 months, depending on how well patients respond to the therapy.

During the study, participants will receive Cabozantinib tablets daily. The effectiveness of the treatment will be monitored through regular medical check-ups and imaging tests. Patients will also complete quality of life questionnaires during the course of their treatment. The study will track how the disease responds to the medication and monitor any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive Cabometyx tablets that you need to take by mouth

    The medication is available in three strengths: 20 mg, 40 mg, and 60 mg film-coated tablets

    Your doctor will determine the appropriate dosage for your treatment

  2. Step 2

    First evaluation period

    After 3 months of treatment, your doctor will evaluate how well the medication is working

    This evaluation includes checking if the tumor has responded to treatment

    You will need to complete a quality of life questionnaire

  3. Step 3

    Six-month assessment

    At 6 months, your doctor will perform another evaluation to check if the disease is under control

    This includes checking if the tumor has shrunk, stayed the same size, or disappeared

    You will continue completing monthly quality of life questionnaires

  4. Step 4

    Ongoing monitoring

    Regular check-ups will continue throughout the treatment period

    Your doctor will monitor any side effects or health changes

    Monthly quality of life questionnaires will continue for up to 12 months

  5. Step 5

    Final assessment

    At 12 months, there will be a comprehensive evaluation of your response to treatment

    A final quality of life questionnaire will be completed at 15 months

    Your doctor will discuss the results and any future treatment plans

Who can join the trial?

22 criteria

  • Age 18 or older with no upper age limit
  • Must have confirmed neuroendocrine neoplasia (a type of tumor that develops from hormone-producing cells)
  • Must have at least one tumor that can be measured by CT or MRI scan
  • Tumor growth rate must be between 20% and 60% (Ki67 measurement)
  • Can have received up to 4 different previous cancer treatments
  • Must have either newly diagnosed or progressing disease
  • Must have ECOG performance status of 0-2 (ability to perform daily activities)
  • Life expectancy of more than 3 months
  • Blood test requirements:
    • Platelets above 80,000 per microliter
    • White blood cells above 3,000 per microliter
    • Hemoglobin above 9 g/dl
    • Total bilirubin less than 3 mg/dl
    • Liver enzymes (AST and ALT) less than 4 times normal
    • Serum creatinine less than 2 mg/dl
    • Kidney function (eGFR) above 40 mL/min/1.73m2
    • BUN less than 5 times normal
    • Lipase less than 3 times normal
    • Albumin at least 2.8 g/dL
    • Blood clotting tests (PT/PTT) no more than 1.5 times normal
    • Protein in urine must meet specific criteria
    • Must be able to understand and comply with study procedures
    • Must provide written informed consent

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Previous treatment with Cabozantinib (the study medication)
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the last 30 days
  • Presence of untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions, including uncontrolled high blood pressure
  • Significant liver problems or abnormal liver function tests
  • Major surgery within 4 weeks before starting the study
  • Active bleeding or conditions that increase bleeding risk
  • Known allergies to the study medication or its components
  • Serious infections requiring treatment
  • Inability to swallow oral medications
  • Mental conditions that could interfere with study participation
  • Any other serious medical condition that could compromise patient safety during the study
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Investigated drugs

Cabozantinib is an oral medication used to treat various types of cancer. It works by blocking specific proteins that contribute to cancer growth and spread. In this trial, it is being studied for treating advanced neuroendocrine tumors. The medication helps reduce the formation of new blood vessels that feed tumors and can help slow down or stop cancer growth. It is taken as a tablet once daily.

What is already known about the treatment

Cabozantinib – A targeted therapy medication administered orally in tablet form that belongs to the class of tyrosine kinase inhibitors. It works by blocking specific proteins that promote cancer cell growth and survival, particularly in neuroendocrine tumors and neoplasms. The drug is primarily used in the treatment of advanced neuroendocrine neoplasms with low proliferation rates, interfering with cellular signaling pathways involved in tumor growth, angiogenesis, and metastasis. Cabozantinib has shown promising results in clinical trials and is currently being studied for its effectiveness in treating various types of neuroendocrine tumors, particularly those classified as G3 (grade 3).

Investigated diseases

  • Neuroendocrine Neoplasia

    A condition where abnormal growths develop from cells of the neuroendocrine system, which are specialized cells that have traits of both nerve cells and hormone-producing cells. These cells can be found throughout the body, particularly in the digestive tract, pancreas, and lungs. The condition typically develops gradually, with tumors forming in various organs and potentially affecting their normal function. The disease can cause the overproduction of various hormones, leading to different symptoms depending on the location and type of cells involved.

  • Neuroendocrine Tumor

    A specific type of growth that begins in specialized cells called neuroendocrine cells, which have characteristics similar to those of nerve cells and hormone-producing cells. These tumors can form in many parts of the body, most commonly in the gastrointestinal tract, pancreas, or lungs. The tumors may produce excess hormones, which can cause various symptoms depending on the location and type of tumor. These growths typically develop slowly over time and can vary in their behavior and effects on the body.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510863-50-00Protocol code02679Estimated enrolment45 patientsSponsorUniversitaetsmedizin Goettingen

sourced from the EU Clinical Trials Register and site verification

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