Not recruitingRare disease

Comparison of two doses of cabozantinib (60 mg vs 140 mg) in patients with progressive metastatic medullary thyroid cancer

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 study focuses on Metastatic Medullary Thyroid Cancer, which is a rare type of thyroid cancer that has spread to other parts of the body. The research evaluates two different doses of cabozantinib, a medication that comes in the form of tablets and capsules under the brand names CABOMETYX and COMETRIQ.

The purpose of the study is to compare the effectiveness and safety of two different daily doses of cabozantinib - 60 mg versus 140 mg - in patients whose cancer is getting worse. The medication is taken orally (by mouth) in the form of either film-coated tablets or hard capsules.

During the study, patients will be randomly assigned to receive one of the two doses of cabozantinib. Neither the patients nor their doctors will know which dose they are receiving. The study will track how well the treatment works by measuring if the cancer stops growing or shrinking, and how long patients live without their cancer getting worse.

The research process

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

Step 1
Initial screening
Your eligibility for the study will be confirmed through medical tests and examinations
A review of your medical history will confirm your diagnosis of medullary thyroid cancer that has spread to other parts of the body
Various tests will be performed, including blood tests and imaging scans (CT or MRI) taken within 28 days before starting the study
Step 2
Assignment to treatment group
You will be randomly assigned to receive one of two doses of cabozantinib:
Either 60 mg daily dose or 140 mg daily dose
Neither you nor your doctor will know which dose you are receiving
Step 3
Treatment period
You will take cabozantinib tablets or capsules by mouth daily
The medication will be either in the form of film-coated tablets or hard capsules
Treatment will continue until your disease progresses or you experience unacceptable side effects
Step 4
Monitoring and assessment
Regular imaging scans will be performed to monitor your cancer
Blood tests will be conducted to check your organ function and blood counts
Your response to treatment will be evaluated using standard criteria (RECIST 1.1)
Side effects will be monitored and recorded throughout the study
Step 5
Follow-up period
After completing or stopping treatment, you will need to continue follow-up visits
You should use appropriate contraception during the study and for 4 months after the last dose
The study is expected to continue until December 2025

Who can join the trial?

12 criteria

Must be 18 years or older at the time of giving consent
Must have confirmed medullary thyroid cancer (MTC) diagnosis through tissue examination
Must have cancer that has spread to other parts of the body (metastatic), confirmed by imaging tests like CT scan, MRI, bone scan, PET scan, or X-ray within 28 days before study start
Must have measurable disease that can be evaluated through CT or MRI scans
Must have evidence that the disease has gotten worse in the past 4 months, shown on imaging tests
Must have recovered from side effects of any previous treatments
Must be able to perform daily activities with minimal assistance (ECOG status ≤ 1)
Must have adequate blood cell counts, liver function, and kidney function based on laboratory tests
Must be able to understand and follow study requirements and sign informed consent
Must agree to use effective birth control during the study and for 4 months after the last treatment if sexually active
For women who can become pregnant: must not be pregnant at screening and must agree to pregnancy testing
Must provide tumor tissue samples for testing, unless already have documented genetic test results (RET or RAS mutation)

Who cannot join the trial?

14 criteria

Prior treatment with cabozantinib (a medication used to treat certain types of cancer)
Presence of brain metastases (cancer that has spread to the brain) that are untreated or unstable
History of significant bleeding in the last 6 months
Uncontrolled high blood pressure (above 150/90 mmHg despite medication)
Major surgery within 4 weeks before starting the study
close
Serious heart conditions, including:
- Heart attack within the last 6 months
- Unstable chest pain
- Severe irregular heartbeat
- Active infections requiring systemic treatment (medications that affect the whole body)
- Severe liver problems
- Severe kidney problems (requiring dialysis)
- Pregnancy or breastfeeding
- Unable to swallow oral medications
- Any condition that would make it unsafe to participate in the study, as determined by the study doctor

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Clinical Medical Center Osijek
Osijek, Croatia
Verified
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Cracow, Poland
Verified
University Of Debrecen
Debrecen, Hungary

Trial locations

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Investigated drugs

Cabozantinib (XL184) is a medication used to treat metastatic medullary thyroid cancer. It works by blocking specific proteins that can cause cancer cells to grow and spread. This medication is taken orally (by mouth) once daily. It helps to slow down or stop the growth of cancer cells in patients whose thyroid cancer has spread to other parts of the body (metastatic) and is getting worse (progressive).

Cabozantinib

What is already known about the treatment

Cabozantinib (XL184) - An oral medication administered daily in tablet form that belongs to the class of tyrosine kinase inhibitors used in cancer treatment. This drug specifically targets and inhibits multiple receptor tyrosine kinases involved in tumor growth and metastasis, including RET, MET, and VEGFR2, making it particularly effective for treating metastatic medullary thyroid cancer. Cabozantinib works by blocking the signaling pathways that promote cancer cell growth and survival, thereby helping to slow or stop the progression of the disease. The medication has been extensively studied in clinical trials and is currently approved for use in progressive, metastatic medullary thyroid cancer, with different dosing regimens being evaluated to optimize its therapeutic benefits while managing side effects.

Investigated diseases

Metastatic Medullary Thyroid Cancer – A rare type of thyroid cancer that begins in specialized thyroid cells called parafollicular C cells, which produce the hormone calcitonin. The disease starts in the thyroid gland, located at the base of the neck, and has spread (metastasized) to other parts of the body. This cancer develops when C cells undergo genetic changes that cause them to multiply uncontrollably and form tumors. As the disease progresses, cancer cells can break away from the original tumor and spread through the bloodstream or lymphatic system to form new tumors in distant organs. The condition typically affects the lymph nodes, liver, lungs, and bones when it becomes metastatic.