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 voluntarily agreed to take part and have signed a consent form
• Adults aged 18 or older, of any gender
• People who have been diagnosed by tissue testing (biopsy) with locally advanced or returned/spread thyroid cancer that cannot be removed with surgery, and whose cancer falls into one of these categories: thyroid cancer that no longer responds to radioactive iodine treatment; differentiated thyroid cancer that is not suitable for radioactive iodine treatment; high-grade, poorly differentiated thyroid cancer; or undifferentiated (anaplastic) thyroid cancer
• People whose genetic test results (NGS testing) show a positive NRAS gene mutation, recorded either in their test report or medical history
• People whose general physical fitness is rated 0–2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People who have at least one measurable tumour lesion based on standard imaging assessment (RECIST v1.1)
• People whose life expectancy is estimated to be more than 12 weeks
• People whose blood, liver, kidney, heart, and clotting function results fall within the ranges required by the trial, as confirmed by blood tests
• Women of childbearing age whose pregnancy test (blood or urine) is negative within 14 days before joining, and who are willing to use effective contraception during the trial and for 3 months after the last dose
• Men who have had a surgical sterilisation procedure, or who are willing to use effective contraception during the trial and for 3 months after the last dose

Who may not be able to join:

• People who had major surgery or serious injury within the 4 weeks before starting the trial (minor procedures such as biopsies or placement of a port or IV line are generally excluded from this rule — confirm with trial site)
• People with large, uncontrollable fluid build-up in body cavities (such as significant fluid around the lungs or in the abdomen) that cannot be managed by draining
• People with significant heart or blood vessel problems, including: a heart attack, unstable chest pain, bypass surgery, coronary stenting, or coronary artery procedure within the past 6 months; symptomatic heart failure; significant irregular heart rhythms or conduction problems within the past 6 months or currently present; blood pressure that remains too high despite medication; certain heart valve abnormalities (grade 2 or higher) on heart ultrasound; a history of a genetic condition causing long QT syndrome; or current use of medications known to prolong the QT interval that cannot be stopped during the study
• People with a history of certain eye conditions affecting the retina (such as retinal vein or artery blockage, diabetic eye disease, high blood pressure–related eye disease, or retinal pigment detachment), or risk factors for retinal vein blockage such as uncontrolled glaucoma or high eye pressure
• People with interstitial lung disease or significant lung inflammation, including radiation-related pneumonitis that affects daily life or requires treatment
• People who test positive for HIV, syphilis, hepatitis C virus (with active infection confirmed), or hepatitis B surface antigen with a high level of hepatitis B virus in the blood
• People who have previously had a bone marrow or organ transplant from another person
• People with an active uncontrolled infection requiring intravenous antibiotics, antifungal, or antiviral treatment within 2 weeks before starting the trial, or unexplained fever above 38.5°C during screening
• People with ongoing, irreversible abnormalities in blood electrolytes (low potassium, low magnesium, or low calcium)
• People with a current or past muscle or nerve disease associated with raised creatine kinase levels (such as inflammatory muscle disease, muscular dystrophy, ALS, spinal muscular atrophy, or rhabdomyolysis)
• People who have had a blood clot in a vein or artery, a stroke, mini-stroke, cerebral haemorrhage, deep vein thrombosis, or pulmonary embolism within the 6 months before starting the trial
• People who experienced a serious (Grade 3) bleeding event within 4 weeks before starting the trial
• People with a history of another cancer within the past 5 years, except for those who have been completely cured of certain skin cancers or cervical pre-cancer, or any cancer from which they have been continuously cancer-free for at least 5 years
• People with a known allergy to any ingredient in the study drug
• People with a confirmed history of neurological or psychiatric conditions, including epilepsy or dementia
• People who have cancer that has spread to the brain or central nervous system
• People whose side effects from previous cancer treatments have not recovered to a mild level (Grade 1 or lower) before starting the trial, with some exceptions such as hair loss, skin colour changes, mild nerve-related side effects, or certain immune therapy-related effects on blood sugar or thyroid
• People with uncontrolled other serious illnesses, including severe diabetes (fasting blood sugar above 250 mg/dL or 13.9 mmol/L), or other conditions requiring ongoing systemic treatment
• People who have received a live or weakened live vaccine within 4 weeks before starting the trial
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 30 days after the last dose; people of reproductive age (including male participants whose female partners could become pregnant) who are unwilling to use effective contraception during this period
• People currently taking certain medications that strongly affect specific liver enzymes (CYP2C9, CYP3A4) and are unable to stop them at least one week before and during the trial, or those currently taking certain medications with a narrow safe dosing range that are processed by the CYP1A2 enzyme
• People who are unable to swallow capsules, have severe ongoing nausea or vomiting, significant absorption problems, external bile drainage, or have had a major portion of the small bowel removed, which could prevent proper absorption of the study drug
• People whom the trial investigators consider unsuitable for other reasons, including personal or social circumstances that could affect safety or the ability to collect reliable data

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