Phase 2 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 diagnosed with differentiated thyroid cancer, medullary thyroid cancer (without a RET gene mutation), or poorly differentiated thyroid cancer, where the cancer has spread beyond the thyroid into nearby tissue or lymph nodes, or has come back or left significant disease in the area — with or without spread to distant parts of the body
• People aged 18 or older at the time of signing the consent form
• People whose cancer has been confirmed by tissue or cell testing as papillary, follicular, oncocytic (Hürthle cell), medullary, or poorly differentiated thyroid carcinoma — or, in some cases, where imaging strongly suggests thyroid cancer even if the biopsy result was uncertain
• People whose cancer complexity has been rated as moderate, severe, very severe, or unresectable using a specific scoring system used by the trial team (Thyroid Neck Group morbidity complexity score of 1 to 4)
• People who are reasonably active and able to care for themselves, as measured by a standard medical scale (ECOG performance status of 0 to 2), with no sudden decline in the two weeks before starting treatment
• People who have recovered from side effects of any previous treatments, or whose remaining side effects are mild and stable
• People whose blood tests show that the heart, liver, kidneys, and bone marrow are functioning adequately, based on tests done within 28 days before starting treatment — including healthy enough levels of blood cells, liver enzymes, kidney function markers, and blood clotting measures
• People who are able to understand the trial requirements and have signed the consent form
• People who are willing to have surgery if their tumour becomes operable during the trial, and — for those treated at the MD Anderson site — willing to have a tumour biopsy before treatment starts (unless the treating doctor considers it unsafe)
• People who are willing to use highly effective contraception during the trial and for a set period after the last dose of treatment (186 days for women who could become pregnant; 96 days for men), and to avoid donating eggs or sperm during that time
• Women who could become pregnant must have a negative pregnancy test at the start of the trial

Who may not be able to join:

• People with medullary thyroid cancer who have a RET gene mutation (either inherited or developed in the tumour)
• People who have previously been treated with the study drug zanzalintinib
• People who have previously been treated with a type of drug called a tyrosine kinase inhibitor
• People who have received other systemic cancer treatments (including chemotherapy, biological therapies, or experimental treatments) within 4 weeks before starting the trial
• People who have had radiation therapy to bones within 2 weeks, any other radiation therapy within 4 weeks, or treatment with radioactive medicines within 6 weeks before starting — or who have ongoing significant complications from past radiation
• People with cancer that has spread to the brain or the area around the brain, unless it has been successfully treated and has been stable for at least 4 weeks, with no symptoms and no need for steroid medicines
• People taking certain blood-thinning medications (such as warfarin or clopidogrel) — some lower-risk blood thinners may be allowed (confirm with trial site)
• People who have used herbal supplements or traditional medicines to treat their cancer within 2 weeks before starting the trial
• People with serious ongoing heart problems, such as significant heart failure, unstable chest pain, dangerous heart rhythm problems, or blood pressure that cannot be controlled with medication
• People who have had a stroke, heart attack, or serious blood clot event within 3 to 6 months before starting the trial, depending on the type of event (confirm with trial site)
• People who have had significant bleeding — such as coughing or vomiting more than half a teaspoon of blood — within 12 weeks before starting the trial
• People with certain lung lesions that are causing symptoms, or disease growing inside the airway associated with major bleeding
• People whose cancer is growing into or around major blood vessels such as the aorta or pulmonary artery (some exceptions may apply — confirm with trial site)
• People with active infections requiring antibiotic or antiviral treatment, or with certain chronic viral infections such as hepatitis B or C — though people living with HIV who meet specific medical criteria may still be considered (confirm with trial site)
• People with serious wounds, ulcers, or bone fractures that are not healing
• People with conditions that severely affect how the body absorbs food or medicines
• People with thyroid hormone levels (too high or too low) that are causing symptoms and are not well controlled
• People with uncontrolled calcium levels in the blood causing symptoms
• People with moderate to severe liver disease
• People who require dialysis for kidney failure
• People who have previously had an organ transplant or stem cell transplant from a donor
• People who have had major surgery within 8 weeks, or minor surgery within 5 days, before starting the trial — and whose surgical wounds have not fully healed
• People whose heart electrical readings (ECG) show a specific measurement called QTcF above 480 ms within 14 days before starting treatment
• People with a psychiatric condition likely to affect their ability to follow the trial requirements or give informed consent
• People who are pregnant or breastfeeding
• People who are unable to swallow tablets or liquid, either by mouth or through a feeding tube
• People with a known allergy to any ingredient in the trial treatment
• People who have or have had another active cancer requiring treatment within the past 2 years that, in the trial doctor's view, would interfere with assessing how the trial treatment is working — with some exceptions for minor skin cancers or low-grade localised cancers
• People with any other condition that, in the trial doctor's judgement, would make participation unsafe or difficult to complete

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