Phase 2 Thyroid Cancer Trial, Completed

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 have been confirmed by tissue or cell testing to have a specific type of differentiated thyroid cancer (DTC), including papillary thyroid cancer (and its variants) or follicular thyroid cancer (and its variants).
• People who have at least one tumour that is large enough to be measured on a scan, as confirmed by a central radiology review.
• People whose disease has shown clear signs of getting worse on scans within the past 13 months before signing the consent form.
• People whose thyroid cancer no longer responds to radioiodine (Iodine-131) treatment, based on specific criteria such as tumours not absorbing iodine, tumours growing after treatment, or having received a very high total dose of radioiodine.
• People who have brain metastases may still be considered, provided they have completed treatment for those (such as radiation or surgery), have been stable and symptom-free, and have not needed steroid medications for at least one month.
• People who are on thyroid hormone therapy to keep their TSH hormone levels within an acceptable range.
• People whose side effects from any previous chemotherapy or radiation have mostly resolved (below a certain severity level), apart from hair loss or infertility.
• People with a performance status score of 0, 1, or 2 on the ECOG scale, meaning they are able to carry out daily activities to at least a moderate degree (confirm with trial site).
• People whose blood pressure is adequately controlled (at or below 150/90 mmHg at screening), with or without blood pressure medication, and whose medication has been stable for at least one week before starting treatment.
• People whose kidneys are working well enough, based on a calculated measure of kidney function.
• People whose blood counts (white blood cells, platelets, and red blood cells) are at or above the required levels.
• People whose blood clotting function is within an acceptable range.
• People whose liver function test results are within acceptable levels.
• People aged 18 or older at the time of signing the consent form.
• Women who are not pregnant and not breastfeeding at the time of screening, confirmed by a pregnancy test.
• Women who are not able to become pregnant — either due to being post-menopausal (no periods for at least 12 consecutive months) or having had a surgical procedure that prevents pregnancy.
• Women who are able to become pregnant and agree to use highly effective contraception throughout treatment and for at least one month after finishing treatment, and who have not had unprotected sex in the 30 days before joining the trial.
• People who are willing and able to give written informed consent and follow all parts of the trial protocol.

Who may not be able to join:

• People whose thyroid cancer is of the anaplastic or medullary type.
• People who have been diagnosed with cancer that has spread to the membranes surrounding the brain and spinal cord (meningeal carcinomatosis).
• People who have already received two or more treatments targeting a specific set of blood vessel growth proteins (VEGF/VEGFR), or who are currently receiving any other active cancer treatment for their thyroid cancer (other than thyroid hormone suppression therapy).
• People who have previously been treated with lenvatinib (the study drug).
• People who have received any cancer treatment within the past 21 days, or any experimental treatment within the past 30 days, before the first dose of the study drug, or who have not yet recovered from side effects of previous cancer treatment.
• People who have had major surgery within 3 weeks before joining, or who have planned surgery scheduled during the study period.
• People with high levels of protein in their urine (above a specific threshold measured over 24 hours).
• People who have a digestive condition that may affect how the study drug is absorbed into the body.
• People with significant heart problems, including a history of certain types of heart failure, unstable chest pain, a heart attack, or stroke within 6 months before starting the study drug, or heart rhythm problems that affect blood circulation.
• People whose heart's electrical activity (measured by ECG) shows a specific type of prolonged interval that reaches a concerning level.
• People who have coughed up bright red blood (at least half a teaspoon) within 3 weeks before starting the study drug.
• People who have an active infection that requires treatment.
• People who have had another active cancer (other than the thyroid cancer being studied, or certain treated skin cancers or cervical changes) within the past 24 months.
• People with bleeding disorders or blood clot disorders.
• People who are known to be intolerant of the study drug or any of its ingredients.
• People with any other medical or personal circumstances that the investigating doctor believes would make participation in the trial unsuitable.
• Women who are pregnant or breastfeeding.

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