Phase 3 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 18 years of age or older.
• People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scoring system called ECOG (scores 0, 1, or 2 — meaning fully active to capable of limited self-care).
• People who have been diagnosed with differentiated thyroid cancer (a type of thyroid cancer that includes papillary or follicular thyroid cancer and their subtypes), where testing has confirmed a specific genetic change called the BRAF V600E mutation.
• People who have previously been treated with radioactive iodine (Iodine-131) for their thyroid cancer, or whose doctors have determined they are not suitable for that treatment, and who are currently taking thyroid hormone suppression therapy.
• People who have previously been treated with at least one — and no more than two — specific targeted cancer drugs called VEGFR-targeting TKIs, which include lenvatinib or sorafenib, for their thyroid cancer.
• People whose cancer can be measured on scans (CT or MRI of the chest, abdomen, and pelvis) taken within 4 weeks before joining the trial.
• People whose cancer has been shown on scans to have grown or spread after their most recent cancer treatment.
• People who have had any previous local treatments (such as surgery, radiation, or ablation) completed at least 4 weeks before joining the trial, with wounds fully healed and any complications resolved.
• People with HIV who are on effective treatment and have had an undetectable level of HIV virus in their blood within 6 months before joining.
• People with chronic hepatitis B who are on appropriate treatment and have an undetectable level of the virus in their blood.
• People who previously had hepatitis C and have been successfully treated and cured, or who are currently being treated for hepatitis C with an undetectable viral level.
• People who have had brain metastases (cancer that has spread to the brain) that have been treated, where follow-up brain scans show the cancer is stable, with no new symptoms and no need for steroid medications at the time of joining.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial's results or safety.
• People with recent blood test results (taken within 28 days before joining) showing that their blood counts, liver function, kidney function, and urine protein levels meet minimum required levels (confirm with trial site for specific values).
• People with a heart rhythm measurement (called QTcF) of 500 milliseconds or less on a heart tracing (ECG) taken within 28 days before joining.
• People who speak English or Spanish (required to complete the quality of life questionnaires used in this trial, as these forms cannot be translated by trial sites).
• People who are willing and able to sign a consent form agreeing to participate, including those who have a legally authorised representative or caregiver who can assist with this process.

Who may not be able to join:

• People with serious heart conditions, including severe heart failure (New York Heart Association class 3 or 4), unstable chest pain (angina), or serious irregular heart rhythms.
• People with high blood pressure that remains above a certain level (above 150/100 mmHg) even with the best available blood pressure treatment.
• People who have had a stroke, heart attack, or a blood clot (such as a deep vein thrombosis or pulmonary embolism) within the 6 months before joining — although people with a more recent deep vein thrombosis may still be considered if it is stable and has been treated with blood-thinning medication for at least 6 weeks (confirm with trial site).
• People who have had significant coughing or vomiting of blood (more than half a teaspoon / 2.5 mL) or other significant bleeding episodes within 3 months before joining.
• People who have lung lesions with hollow cavities, or tumours that are growing into major blood vessels in the lungs.
• People who are currently taking blood-thinning medications (anticoagulants) or platelet-inhibiting drugs, with the exception of low-dose aspirin for heart protection, or therapeutic anticoagulation in people without brain metastases who have been on a stable dose for at least 6 weeks with no significant bleeding complications (confirm with trial site).
• People with certain bowel or digestive conditions that carry a high risk of tearing or abnormal connections forming, including tumours invading the digestive tract, active stomach ulcers, inflammatory bowel disease, ulcerative colitis, diverticulitis, gallbladder or bile duct inflammation, appendicitis, pancreatitis, or blockages of the stomach outlet or bile ducts.
• People who have had an abnormal opening (fistula), a tear in the digestive tract, a bowel blockage, or an abdominal abscess within 6 months before joining.
• People who have had major surgery (such as bowel surgery or brain surgery) within 8 weeks before joining, or who have not had complete wound healing from major surgery within 4 weeks or from minor surgery within 10 days before joining.
• People whose cancer has grown by 2 cm or more within 3 months, or by 1.5 cm or more within 2 months, before joining.
• People whose thyroid cancer has been identified as an aggressive type called anaplastic thyroid cancer at or after the time their cancer returned.
• People who have previously been treated with cabozantinib or any BRAF-targeted therapy for thyroid cancer.
• People who are pregnant or breastfeeding.
• People who are able to become pregnant and have not had a pregnancy test (blood or urine) within 14 days before joining (confirm with trial site for the definition of childbearing potential that applies).
• People who are not willing to use effective non-hormonal contraception or abstain from sexual intercourse during the trial and for a defined period after the last dose of study medications — noting that one of the study drugs (dabrafenib) may reduce the effectiveness of hormonal contraceptives such as the pill.
• People who do not meet the minimum required levels for blood counts, liver function, kidney function, or urine protein on recent blood tests (confirm with trial site for specific values).

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