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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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
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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medisprof S.R.L.	Cluj Napoca	Romania
Klinički bolnički centar Zagreb (University Hospital Center Zagreb)	Zagreb	Croatia

Other Sites

Site Name	City	Country
National Institute Of Endocrinology C.I. Parhon	Bucharest	Romania
University Of Debrecen	Debrecen	Hungary
Clinical Medical Center Osijek	Osijek	Croatia
Ntcmfstq Ixqumsup Omrzpzxbz Ick Myzar Sobfmqwrmwsxdrhgdmadkdfbbeqb Ijgnynln Bsourntg	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	01.04.2015
Hungary	Not recruiting	01.04.2015
Poland	Not recruiting	01.04.2015
Romania	Not recruiting	01.04.2015

Trial locations

Investigated drugs:

Cabozantinib

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).

Investigated diseases:

Medullary thyroid cancer

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.

Trial ID:

2024-516480-90-00

Protocol code:

XL184-401

NCT ID:

NCT01896479

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?