Phase 2 Thyroid Cancer Trial, Recruiting

Written by an AI model from the 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 given their written agreement to take part, either personally or through an authorised representative
• People who are willing to be followed up for approximately 14 months
• People aged 18 years or older at the time of giving consent
• People who have been diagnosed with a type of thyroid cancer that originates from follicular cells (such as papillary, follicular, or Hürthle cell thyroid cancer)
• People whose thyroid cancer has tested positive for a specific gene change called BRAFV600E, confirmed through previous testing or a tumour or biopsy sample
• People whose cancer is considered high risk for coming back, meaning their cancer has one or more of the following features: the cancer grew beyond the thyroid gland itself; a certain type of thyroid cancer (follicular) with significant spread into blood vessels; papillary thyroid cancer with blood vessel invasion; cancer that has spread to lymph nodes in a significant way (any node larger than 3 cm, more than 4 affected nodes, or cancer that has broken through the outer wall of a lymph node); both the BRAF mutation and another gene change called TERT promoter mutation; blood protein levels after surgery that suggest the cancer may have spread to distant parts of the body; or confirmed spread to distant parts of the body (for a specific exploratory group only)
• People who are generally well enough to carry out light daily activities, with little or no limitation (as measured by a standard medical scale rated 0 or 1)
• People whose blood pressure is at or below 140/90 mmHg at the screening visit, whether or not they take blood pressure medication, with no changes to those medications in the week before treatment starts
• People whose kidneys are functioning at an adequate level, as measured by a standard calculation (confirm with trial site)
• People with adequate levels of certain blood cells and blood components, including white blood cells, red blood cells, and platelets, all meeting specific minimum levels (confirm with trial site for exact values)
• People with normal blood clotting function, as shown by a standard blood test result within an acceptable range
• People with liver enzyme and bilirubin levels within acceptable limits, with slightly higher limits allowed for people who have cancer that has spread to the liver, or who have a specific harmless liver condition called Gilbert's syndrome
• Women who could potentially become pregnant must have a negative pregnancy test within 7 days before starting the study treatment
• Women who could potentially become pregnant, and men who could father a child, must agree to use effective contraception (such as hormonal or barrier methods) for at least 3 months before the screening visit and continuing through 1 year of study follow-up
• People who do not speak English, and adults who need support to give consent, are not excluded from taking part

Who may not be able to join:

• People who have previously received radioactive iodine (RAI) treatment
• People who have previously been treated with certain targeted drugs used for BRAF, MEK, or similar pathways, including sorafenib, dabrafenib, vemurafenib, encorafenib, binimetinib, cobimetinib, trametinib, selumetinib, lenvatinib, sunitinib, axitinib, cabozantinib, vandetanib, pazopanib, or similar medicines
• People whose thyroid cancer is classified as low to intermediate risk (i.e., it does not have the high-risk features listed above)
• People for whom radioactive iodine treatment is medically not suitable
• People with undifferentiated (anaplastic) thyroid cancer or medullary thyroid cancer
• People who have had major surgery within 4 weeks before the first dose of treatment
• People with a significant level of protein detected in their urine, specifically 1 gram or more over a 24-hour urine collection
• People who need other local treatments such as surgery, radiation directed at a specific area, or heat-based tumour destruction at the time of joining the trial
• People who have received external beam radiation therapy for thyroid cancer within 4 weeks before starting treatment
• People with a condition affecting how the gut absorbs food or medication, or any other condition the trial doctor believes would interfere with how the body processes the study drugs
• People with a history of significant heart failure, unstable chest pain, heart attack, stroke within the past 6 months, a serious heart rhythm problem, or uncontrolled high blood pressure
• People whose heart electrical activity test (ECG) shows a specific measurement (QTc interval) at or above 480 milliseconds
• People who have coughed up bright red blood within the past 2 months, or who have any active bleeding, blood clotting problems, or other conditions that carry a high risk of bleeding
• People who currently have an active infection that requires treatment through a drip or tablets
• People who have had another active cancer within the past 24 months, apart from the thyroid cancer being studied, or certain minor skin or cervical/bladder cancers that have been fully treated
• People with any other medical condition that, in the trial doctor's judgement, could make it unsafe for them to take part
• Women who are currently pregnant or breastfeeding
• People who have received an injection of contrast dye (used in certain scans) within the 12 weeks before enrolling (enrolment may be possible after that 12-week period has passed)
• People with a history of a blockage in a blood vessel in the eye called retinal vein occlusion
• People with a history of a condition affecting the central part of the retina in the eye (central serous retinopathy)
• People with a known allergy or sensitivity to the study drugs or any of their ingredients
• People with any other medical, psychological, or social condition that, in the trial doctor's judgement, would make participation unsafe or unsuitable
• People with any condition that might make the trial results difficult to interpret
• People who are unlikely to follow the trial procedures as required, for any reason including practical or logistical difficulties

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