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 who have been diagnosed with a specific type of thyroid cancer (follicular-derived, non-anaplastic) that has spread or cannot be removed by surgery, and whose cancer has a specific genetic change called a RET gene fusion, confirmed by an accredited laboratory.
• People whose RET gene fusion was detected using one of several approved testing methods, including next-generation sequencing (NGS), qPCR, or FISH testing.
• People aged 18 and older whose cancer can be measured on scans according to standard criteria (RECIST v1.1); people aged 12 to under 18 may also be eligible if their tumour is visible on imaging, even if it does not meet the full measurement threshold.
• People whose largest single tumour deposit is no bigger than 4.0 cm across.
• People whose thyroid cancer no longer responds to radioiodine (RAI) treatment, as defined by several specific patterns of RAI non-response or disease progression (confirm specific definition with trial site).
• People who have received no more than a total treatment dose of 500 mCi of radioiodine (not counting doses given only for diagnostic scans).
• People whose disease is causing no symptoms or only mild symptoms, as assessed by the treating doctor (for example, mild bone pain not requiring strong pain medication, or a mild cough that does not limit daily activities).
• People who have previously received external beam radiation therapy, provided any disease within the previously treated area can be measured on scans.
• People who have received no more than one prior systemic treatment (such as lenvatinib, sorafenib, or similar drugs) for RAI-refractory thyroid cancer; prior treatment with RET-specific drugs such as selpercatinib or pralsetinib is not permitted.
• People for whom at least 28 days have passed since any prior radiation therapy, major surgery, or systemic thyroid cancer treatment (thyroid hormone replacement does not count toward this).
• People aged 12 to under 18 may be considered if permitted by local regulatory authorities and the institution's review board; those aged 12 to under 18 will be asked to provide assent, and their legal guardian will be asked to provide written consent.
• People aged 16 and older with a good general physical functioning level (ECOG performance status of 0 or 1); people aged 12 to under 16 must meet a similar standard using a different scale (Lansky Performance Score of 60 or above).
• People with a life expectancy of more than 12 months.
• People who are able to swallow medications and who do not have any digestive tract conditions that would affect how the drug is absorbed.
• People whose blood test results, taken within 7 days before starting treatment, show adequate bone marrow, liver, and kidney function meeting specific thresholds (confirm exact values with trial site).
• People whose blood levels of potassium, calcium, and magnesium are within the normal range at the time of testing (supplements to maintain these levels are permitted).
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with chronic hepatitis B who are on suppressive therapy and have an undetectable viral load.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
• People who have previously had brain metastases that have been treated, provided they have no symptoms and follow-up brain imaging shows no sign of the cancer growing in the brain.
• People who have had another cancer in the past or at the same time, where that cancer or its treatment is unlikely to interfere with this trial — for example, non-melanoma skin cancer, cervical carcinoma in situ, a cancer diagnosed two or more years ago that is not currently being treated, or breast or prostate cancer being managed with hormone therapy with no active disease.
• People with a history of heart disease or prior treatment with heart-affecting drugs, provided their heart function is assessed as class 2B or better using a standard classification system.
• Women of childbearing potential and their male partners must agree to use highly effective contraception before, during, and for 6 months after the last dose of the study drug; women must also have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding from two months before starting through at least one week after the last dose.
• People who are able to understand the study and are willing to sign a written informed consent form.

Who may not be able to join:

• People who have received chemotherapy, a targeted kinase inhibitor (MKI), or radiation therapy within the past 4 weeks.
• People who have received radioiodine (I-131) treatment within the past 12 months.
• People who are still experiencing side effects from a previous cancer treatment that are more than mild in severity (above Grade 1), except for hair loss.
• People who are currently taking part in another clinical trial involving an investigational treatment.
• People who have brain metastases causing symptoms, or tumours that are pressing on the spinal cord.
• People with significant active heart disease, a history of a specific dangerous heart rhythm called Torsades de pointes, a heart attack within the past 6 months, or an abnormal heart electrical reading (QTcF above 470 msec on more than one test during screening).
• People with uncontrolled high blood pressure (above 160/95 mmHg) at the time of screening; re-screening may be possible after appropriate treatment for high blood pressure.
• People with an active, uncontrolled bacterial, viral, or fungal infection, or other serious ongoing illness such as uncontrolled high blood pressure or diabetes, symptoms or a diagnosis of interstitial lung disease, or other serious medical conditions that the doctor believes would make participation unsafe.
• People with uncontrolled symptoms of an overactive or underactive thyroid.
• People with symptoms caused by abnormally high or low calcium levels in the blood.
• People with active bleeding or who are considered to be at significant risk of bleeding.
• People who are currently taking medications known to cause a specific type of heart rhythm abnormality (QTc prolongation).
• People with significant problems absorbing food or medications through the digestive tract.
• People with other serious uncontrolled illnesses that would interfere with the ability to complete the study treatment.

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