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    A clinical trial to compare pralsetinib with standard-of-care treatment (cabozantinib or vandetanib) in people with RET-mutated medullary thyroid cancer (RET-MTC)

    A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC)

    • Cancer
    • Thyroid Cancer
    • Medullary Thyroid Cancer

    Basic Details

    Gender
    All
    Age
    ≥12 Years
    Healthy Volunteers
    No
    Sponsor Hoffmann-La Roche
    Phase Phase 3
    Study Identifier NCT04760288, CO42865, 2020-005269-15

    How does the AcceleRET-MTC clinical trial work?
    This clinical trial is recruiting people who have a type of disease called medullary thyroid cancer (MTC), a rare type of cancer that affects the thyroid gland near the base of the throat. In order to take part, patients must also have changes in a gene called RET, leading to RET-mutated MTC (RET-MTC).

    The purpose of this clinical trial is to compare the effects, good or bad, of pralsetinib against standard-of-care treatment in patients with RET-MTC. If you take part in this clinical trial, you will receive either pralsetinib or the clinical trial doctor’s choice of standard-of-care treatment (cabozantinib or vandetanib). 

    How do I take part in this clinical trial?
    To be able to take part in this clinical trial, you must be at least 18 years old (or at least 12 years old, depending on local rules and guardian consent). You must have been diagnosed with MTC that cannot be removed with surgery and/or has spread to other parts of the body. Your cancer must also have changes in a gene called RET, detected by a genetic test. In the last 14 months, you must have been confirmed as having progressive disease (your disease is getting worse). 

    You must not have received any previous treatment with a specific kind of anti-cancer drug called a kinase inhibitor, and must not have received any radiation therapy in the 14 days before you start this trial. If you are taking certain other medications or have certain other medical conditions, you may not be able to take part in this trial. If you are pregnant or breastfeeding, or intend to become pregnant soon after taking part in this trial, you will not be able to take part. 

    If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

    You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

    Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part. 

    While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception for safety reasons. 

    What treatment will I be given if I join this clinical trial? 
    Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given either:

    • Pralsetinib, as capsules to be swallowed once every day 
    • OR clinical trial doctor’s choice of cabozantinib (as capsules) or vandetanib (as tablets), to be swallowed once every day 

    You will have an equal chance of being placed in either group. 

    How often will I be seen in follow-up appointments and for how long?
    You will be given the clinical trial treatment (pralsetinib, cabozantinib or vandetanib) for as long as it can help you. If your cancer gets worse while taking cabozantinib or vandetanib, you may be able to receive pralsetinib if you meet certain criteria. 

    You are free to stop treatment at any time. While being given treatment, you will have clinic visits every 28 days (one cycle). After Cycle 12 is completed (after roughly one year), you will have clinic visits every 12 weeks (three months) until Cycle 24 (roughly the second year) and every 16 weeks (four months) after that. These visits will include checks to see how you are responding to the treatment and any side effects that you may be having. In some areas and if you agree to it, a nurse may come to your home to conduct these checks instead. 

    Your clinical trial doctor will see you roughly 30 days after your last treatment dose. After this, you will continue to be seen roughly every three months so that the clinical trial doctor can check how you are and whether you have started any new treatments. These visits (or telephone calls) will continue for as long as you agree. 

    What happens if I am unable to take part in this clinical trial?
    If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

    For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/record/NCT04760288

    Trial-identifier: NCT04760288

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

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      What is Clinical Research?

      In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.