Study on Cabozantinib for Patients with Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer

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What is this study about?

This clinical trial is focused on studying a type of thyroid cancer known as Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer. This is a condition where the thyroid cancer does not respond to treatment with radioactive iodine. The study is testing a medication called Cabozantinib, which is taken as a film-coated tablet. Cabozantinib is also known by its code name, XL-184. The purpose of the study is to explore how well Cabozantinib works in treating this type of thyroid cancer and to see if certain markers in the blood can predict how patients will respond to the treatment.

Participants in the study will take Cabozantinib tablets by mouth. The study will last for a period of time, during which participants will have regular check-ups and tests to monitor their health and the effects of the medication. The study will also collect blood samples to look for specific markers that might help predict the effectiveness of the treatment. These markers are like signals in the blood that can give doctors clues about how the cancer is responding to the medication.

The study aims to gather information on how well Cabozantinib controls the disease, how long any positive effects last, and the overall survival of participants. It will also look at the safety of the medication by tracking any side effects that occur. The information collected will help doctors understand more about the potential benefits and risks of using Cabozantinib for treating this specific type of thyroid cancer.

1 joining the study

Upon joining the study, the patient will provide written informed consent. This is a formal agreement to participate in the trial after understanding its requirements and potential risks.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of advanced radioactive-iodine refractory differentiated thyroid cancer and ensuring the patient meets all inclusion criteria.

3 baseline sample collection

Blood samples will be collected to analyze molecular biomarkers. This will help predict the response to the treatment with cabozantinib.

4 treatment initiation

The patient will begin treatment with cabozantinib. The medication is available in film-coated tablets of 20 mg, 40 mg, and 60 mg, taken orally. The specific dosage and frequency will be determined by the study protocol.

5 ongoing treatment and monitoring

The patient will continue taking cabozantinib as prescribed. Regular monitoring will occur to assess the treatment’s effectiveness and any side effects. Blood samples will be collected again after 24 weeks of treatment.

6 end of treatment

At the end of the treatment period, further blood samples will be collected. This will help evaluate the treatment’s impact and any changes in the molecular biomarkers.

7 follow-up

If a new line of treatment is started more than three months after the end of the study treatment, additional blood samples may be collected to continue monitoring the patient’s condition.

Who Can Join the Study?

Must be a male or female who is 18 years old or older.
Females who can have children must have a negative pregnancy test and agree to use a highly effective birth control method during the study and for 4 months after the last dose of the study drug. A woman is considered able to have children from the start of menstruation until menopause unless she is permanently unable to have children.
Males who are not sterile must agree to use a highly effective birth control method during the study and for 4 months after the last dose of the study drug. A sterile male is one who has been proven to have no sperm in a semen sample.
Must be able to understand and follow the study requirements and have signed a consent form.
Must have a confirmed diagnosis of differentiated thyroid cancer (DTC) through a tissue sample, including specific types like papillary or follicular thyroid carcinoma.
Must have measurable disease based on specific imaging tests like CT or MRI done within 28 days before starting the study treatment.
Must have been treated with or found ineligible for treatment with Iodine-131 for DTC.
Must have been treated and shown disease progression with one or two specific drugs targeting VEGF for DTC, such as lenvatinib or sorafenib.
Must have recovered from side effects of any previous treatments to a certain level, unless the side effects are not significant or are stable with supportive care.
Must have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have adequate organ and bone marrow function based on specific laboratory tests done within 10 days before starting the study treatment. This includes having enough white blood cells, platelets, and hemoglobin, and normal levels of liver and kidney function tests.

Who Cannot Join the Study?

Patients who have not been diagnosed with Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer cannot participate. This means the study is only for those whose thyroid cancer does not respond to radioactive iodine treatment.
Patients who are not within the specified age range cannot participate. The study is for certain age groups, but the exact ages are not specified here.
Patients who are not part of the specified clinical trial group cannot participate. This means the study is for a specific group of patients, but the details are not provided here.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations can include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital General Universitario Morales Meseguer	Murcia	Spain
Hospital Universitario Rey Juan Carlos	Mostoles	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hmeyeozu Vkjd dasvvtwy	Barcelona	Spain
Heuffzis Unlylmpqwrylp db A Cvfxrl	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	29.05.2023

Trial locations

Investigated drugs:

Cabozantinib

Cabozantinib is a medication used in this clinical trial to treat patients with advanced differentiated thyroid cancer that does not respond to radioactive iodine treatment. It works by inhibiting certain proteins that promote cancer cell growth, helping to slow down or stop the progression of the cancer.

Investigated diseases:

Thyroid cancer

Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer – This is a type of thyroid cancer that does not respond to radioactive iodine treatment, which is typically used to target thyroid cancer cells. It is considered advanced when the cancer has spread beyond the thyroid gland to other parts of the body. The disease progresses as the cancer cells continue to grow and spread, despite the lack of response to standard radioactive iodine therapy. This form of thyroid cancer may require alternative treatment approaches due to its resistance to conventional methods. The progression can vary, but it often involves the cancer becoming more aggressive over time.

Trial ID:

2024-511292-15-00

Protocol code:

GETNE-T2216

NCT ID:

NCT05660954

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Cabozantinib for Patients with Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer

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