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 aged 18 or older who have a confirmed diagnosis of either differentiated thyroid cancer (such as papillary, follicular, Hürthle cell, or poorly differentiated thyroid cancer) for Cohort A, or anaplastic thyroid cancer for Cohort B.
• People whose thyroid tumour has been tested in a certified laboratory and found to have at least one of these specific genetic changes: a RAS mutation, NF1 mutation, RET rearrangement, NTRK rearrangement, ALK rearrangement, or certain non-standard BRAF changes (not the common V600E/K type).
• People in Cohort A whose cancer has come back or spread and cannot be cured by surgery or radiation, and whose disease has been getting worse within the last 14 months.
• People in Cohort A whose cancer no longer responds to radioactive iodine (RAI) treatment, based on specific criteria such as having received a high lifetime dose of RAI, having a tumour that does not absorb RAI, having a lesion that progressed despite RAI, or having a lesion that shows up on a special type of scan called an FDG-PET scan.
• People who have been treated with any number of prior cancer therapies.
• People who have measurable tumour(s) visible on imaging scans, based on standard measurement criteria called RECIST v1.1.
• People who are generally well enough to carry out everyday activities, with a performance rating of 0 or 1 on a standard scale used by doctors (ECOG scale — roughly meaning fully active or able to do light activity).
• People in Cohort A who have waited long enough since their last cancer treatment: at least 6 months since radioactive iodine therapy, at least 1 week since radiation therapy, and at least 4 weeks since chemotherapy or targeted therapy.
• People who are able to swallow tablets or capsules and absorb them normally, without significant digestive problems.
• People whose side effects from previous treatments have mostly resolved, with only mild remaining effects allowed (hair loss and mild nerve-related symptoms are exceptions).
• People who have tumour tissue samples available (either a preserved tissue block or at least 20 unstained slides) for research testing.
• People who agree to have two research biopsies (small tissue samples taken from a tumour), though there are several situations where a person may be excused from one or both biopsies — the trial site can advise on this.
• People whose heart electrical activity (measured by an ECG) falls within acceptable ranges: a QTc interval below 460 ms for women and 450 ms or below for men (this does not apply to people with certain heart conduction conditions).
• People whose heart is pumping well enough, with the heart's pumping strength (left ventricular ejection fraction) above 50% on a heart scan.
• People whose blood test results meet all of the following minimum levels (the trial site will check these): adequate white blood cells, neutrophils, platelets, and haemoglobin; acceptable liver enzyme, bilirubin, kidney, albumin, muscle enzyme, and blood clotting levels.

Who may not be able to join:

• People who have brain or spinal fluid (leptomeningeal) spread of cancer that is causing symptoms and has not been treated (people with treated or symptom-free brain spread may still be considered).
• People who have previously been treated with a MEK inhibitor, a FAK inhibitor, or a drug targeting certain BRAF changes — unless those treatments were given specifically to help radioactive iodine work better.
• People who have received an experimental cancer treatment within 4 weeks before the first dose of the study drug.
• People who have had major surgery within 4 weeks, minor surgery within 2 weeks, or radiation therapy within 1 week before starting the study drug.
• People currently taking the blood thinner warfarin (switching to a different type of blood thinner may be an option — confirm with trial site).
• People currently taking certain medications, supplements, herbal products, or foods that strongly affect how the body processes drugs through pathways called CYP3A4, CYP2C9, or P-glycoprotein — including grapefruit, grapefruit juice, and St. John's Wort.
• People with a history of glaucoma, retinal vein blockage (RVO), or conditions that raise the risk of RVO, including uncontrolled high blood pressure or uncontrolled diabetes.
• People with a history of retinal eye problems, or a current eye pressure above 21 mmHg.
• People with high blood pressure that remains above 140/90 mmHg despite medication.
• People with an active hepatitis B infection.
• People known to have HIV or an active hepatitis C infection (a previously treated and cleared hepatitis C infection may be acceptable if a blood test confirms no active virus).
• People who have had a confirmed COVID-19 infection with symptoms within 28 days before starting the study drug.
• People with a history of rhabdomyolysis (a serious condition where muscle tissue breaks down rapidly).
• People with current or recent serious heart or lung conditions, including heart failure, a heart attack within the last 6 months, unstable heart rhythms, unstable chest pain (angina), or severe lung disease.
• People who cannot swallow oral medications or who have significant problems absorbing medications due to stomach removal or active inflammatory bowel disease.
• People who are pregnant or breastfeeding.
• People with a known allergy to mannitol, magnesium stearate, or HPMC (hydroxypropyl methylcellulose) — ingredients found in the study drug capsules.
• People with any other serious medical condition that the trial doctor believes would put them at unacceptably high risk of harm.

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