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Study on the Effectiveness of Lenvatinib for Patients with Advanced Gastrointestinal Stromal Tumors After Imatinib and Sunitinib Treatment Failure

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer known as Gastrointestinal Stromal Tumor (GIST), which is a rare cancer affecting the digestive tract. The study is specifically for patients whose cancer has spread to other parts of the body or is locally advanced, meaning it has grown significantly in its original location. The trial is testing the effectiveness of a medication called lenvatinib, which is taken in the form of hard capsules. Lenvatinib is a type of drug known as a tyrosine kinase inhibitor, which works by blocking certain proteins that promote cancer cell growth. The study will compare lenvatinib to a placebo, which is a substance with no active medication, to see how well it works in patients who have not responded to previous treatments with other drugs called imatinib and sunitinib.

The purpose of this study is to evaluate how well lenvatinib can control the growth of the cancer compared to a placebo. Participants in the study will be randomly assigned to receive either lenvatinib or the placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The trial will last for a period of time during which participants will take the medication and have regular check-ups to monitor their health and the progress of their cancer.

Throughout the study, the main focus will be on measuring how long patients can live without their cancer getting worse, which is known as progression-free survival. Other aspects being studied include overall survival, which is the length of time patients live after starting the trial, and the objective response rate, which measures how many patients experience a significant reduction in their cancer. The study will also assess the quality of life of participants and monitor any side effects they may experience. This information will help determine the potential benefits and risks of using lenvatinib for treating advanced GIST.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have a confirmed diagnosis of gastrointestinal stromal tumor (GIST) that is locally advanced or has spread to other parts of the body.

    The patient must have previously tried and not responded to the medications imatinib and sunitinib.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure the patient meets all eligibility criteria, including age, health status, and previous treatment history.

    The patient must have measurable disease progression and normal organ and bone marrow function.

  3. Step 3

    Randomization

    The patient will be randomly assigned to receive either the medication lenvatinib or a placebo.

    This process is double-blinded, meaning neither the patient nor the study team will know which treatment the patient is receiving.

  4. Step 4

    Medication administration

    The patient will take lenvatinib in the form of hard capsules, either 4 mg or 10 mg, depending on the assigned dosage.

    The medication is taken orally, following the prescribed dosage and frequency as directed by the study protocol.

  5. Step 5

    Ongoing monitoring

    The patient's health and response to the treatment will be monitored regularly throughout the study.

    This includes assessments of tumor progression, overall survival, and quality of life using specific questionnaires.

  6. Step 6

    Completion of the study

    The study is expected to conclude by March 16, 2025.

    Upon completion, the patient's overall response to the treatment will be evaluated, including any side effects experienced during the trial.

Who can join the trial?

16 criteria

  • Must be a male or female who is at least 18 years old.
  • Must use effective birth control if sexually active, along with their partner.
  • Must be able to understand and agree to attend follow-up visits.
  • Must have medical insurance coverage.
  • Must sign a consent form showing they understand the important details of the study.
  • Must have a confirmed diagnosis of **GIST** (Gastrointestinal Stromal Tumor).
  • The disease must be either locally advanced or **metastatic** (spread to other parts of the body).
  • Must have previously tried and not responded to the medications **imatinib** and **sunitinib**.
  • Must have measurable disease according to specific medical guidelines.
  • Must show documented disease progression, meaning the disease is getting worse.
  • Must have an **ECOG performance status** of 0, 1, or 2, which is a scale that measures how well a patient can perform daily activities.
  • Must have normal organ and bone marrow function, which includes:
    • Enough white blood cells, red blood cells, and platelets.
    • Normal blood clotting ability.
    • Normal liver function tests.
    • Normal kidney function tests.
    • Low levels of protein in the urine.

Who cannot join the trial?

4 criteria

  • Patients who have not experienced failure of treatment with imatinib and sunitinib. This means that if these medications are still working for you, you cannot participate.
  • Patients who do not have locally advanced or metastatic GIST. This means the cancer must have spread or be in a stage that is not easily treatable with surgery.
  • Patients who are not within the specified age range. The study is only for certain age groups.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, like children or those unable to make decisions for themselves, are not included.
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Investigated drugs

  • Lenvatinib

    is a medication being studied for its ability to treat patients with locally advanced or metastatic gastrointestinal stromal tumors (GIST) after other treatments have not worked. It is being compared to a placebo to see if it can help reduce the size of the tumors or slow their growth.

  • Imatinib

    is a medication that was previously used by patients in this study. It is typically used to treat certain types of cancer by blocking the action of a protein that causes cancer cells to multiply.

  • Sunitinib

    is another medication that patients in this study have used before. It works by blocking multiple proteins that promote cancer cell growth, and it is often used when other treatments like imatinib are no longer effective.

What is already known about the treatment

Lenvatinib – Lenvatinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating patients with locally advanced or metastatic gastrointestinal stromal tumors (GIST) after the failure of other treatments like imatinib and sunitinib. The medication works by inhibiting certain proteins that promote tumor growth, specifically targeting receptors involved in the formation of blood vessels that supply the tumor. Lenvatinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Gastrointestinal Stromal Tumor (GIST) – A gastrointestinal stromal tumor is a type of tumor that occurs in the digestive tract, most commonly in the stomach or small intestine. It originates from special cells in the wall of the gastrointestinal tract known as interstitial cells of Cajal. These tumors can be benign or malignant, and their growth can lead to symptoms such as abdominal pain, bleeding, or obstruction. GISTs are often driven by mutations in specific genes, which can influence their behavior and response to treatment. The progression of GISTs can vary, with some remaining stable for long periods, while others may grow or spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513984-22-00Estimated enrolment74 patientsSponsorCentre Leon Berard

sourced from the EU Clinical Trials Register and site verification

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