Phase 4 Thyroid Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to follow all study requirements and can give written, signed, and dated consent to participate.
• People who are 18 years of age or older at the time of signing the consent form.
• People with a body mass index (BMI) between 18 and 32, and who weigh at least 50 kg at the time of screening.
• People whose general physical functioning is rated at level 2 or better on a standard cancer performance scale (this measures how much a person's illness affects their daily activities — confirm with trial site).
• People who have recovered from most side effects of previous cancer treatments, with only mild or no remaining effects (hair loss and mild nerve-related symptoms are exceptions).
• People who have a confirmed diagnosis of an advanced or spreading solid tumour that has stopped responding to standard treatments, and whose tumour has a specific genetic change called an RET fusion or mutation, confirmed by an approved test.
• People whose blood counts, liver function, kidney function, and other key measurements meet specific healthy ranges at screening (the trial site will check these through blood tests).
• People who have waited at least 4 weeks since their last major surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or gene therapy, and have recovered from related side effects — or at least 6 weeks if their last treatment was a long-acting type of therapy.
• Women who are not able to become pregnant (for example, due to surgery or having gone through menopause).
• Men with female partners who could become pregnant must agree to use highly effective contraception during the study and for 90 days after the last dose.
• Men must agree not to donate sperm during the study and for 90 days after the last dose.

Who may not be able to join:

• People with abnormal medical history, physical exam findings, vital signs, heart tracings (ECG), or blood test results at screening that the investigator believes could interfere with the study or affect safety.
• People who have had surgery (such as gastric bypass) or have a medical condition that may significantly affect how study medications are absorbed.
• People with a history of lung inflammation (pneumonitis) within the last 12 months.
• People with a history of active or latent tuberculosis (TB), regardless of past treatment, or who test positive for a latent TB infection during screening.
• People who had a serious infection requiring intravenous or systemic antibiotics within 7 days before starting the study, or who have any active infection the investigator considers a safety risk.
• People with significant uncontrolled heart disease, including severe heart failure, a heart attack or unstable chest pain within the past 6 months, certain heart rhythm problems, severely uncontrolled high or low blood pressure, a history of a specific type of heart rhythm disorder (long QT syndrome or torsades de pointes), or abnormal heart electrical readings on two separate ECGs.
• People who have cancer that has spread to the brain or spinal cord, or who have a primary brain tumour.
• People who have used steroid medications (taken throughout the body, not just on the skin) within 4 weeks before starting the study.
• People who received more than a specific dose of radiotherapy to the lungs within 6 months before joining.
• People with a history of multiple or severe allergies to medicines or foods, or a history of a severe allergic reaction (anaphylaxis).
• People who are currently taking certain prohibited medications or following certain prohibited procedures (confirm with trial site for a full list).
• People with medical conditions or treatments that make it unsafe to take the specific study drugs being tested (confirm with trial site).
• People who have consumed alcohol within 72 hours before the first study drug dose, or who plan to drink alcohol during the study.
• People who have taken part in another clinical trial within 30 days before starting (or within 5 half-lives of that trial drug, whichever is longer), or who have been exposed to more than 3 investigational drugs in the past 12 months.
• People who test positive for hepatitis B or hepatitis C at screening (unless a follow-up PCR test comes back negative).
• People who test positive for HIV at screening.
• People who test positive for certain drugs (not explained by prescribed medications) or alcohol at screening or before the first dose.
• People who are legally unable to make decisions for themselves or are otherwise considered vulnerable.
• Women who are pregnant or breastfeeding.
• People who plan to become pregnant or father a child (including through egg or sperm donation) during the study or within 3 months after the last dose.
• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People who are currently taking certain medications that strongly or moderately affect how the body processes the study drug, within specific timeframes before starting (confirm with trial site for the full medication list).
• People with a significant ongoing or historical medical condition affecting the heart, lungs, digestive system, kidneys, liver, nervous system, mental health, muscles, urinary system, skin, blood, or other areas that the investigator believes could affect study participation or how the drug is processed by the body.
• People with a history of a second cancer, unless they have been cancer-free for at least 12 months or are considered cured by surgery — with some exceptions for certain low-risk skin cancers, early-stage prostate cancer not requiring treatment, or cancers that have been fully removed.

Important: Always verify eligibility with the trial site directly before applying.