Phase 2 Endometrial 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:

• Women aged 18 or older.
• People with a confirmed diagnosis of certain gynaecological cancers (including endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or other solid gynaecological cancers) that have specific genetic changes — mutations in RAS, BRAF (type I, II, or III), loss of NF-1 function, or RAS activation — identified through previous genetic or molecular testing.
• People for whom adequate tumour tissue samples (either stored samples less than 5 years old, or a fresh biopsy) are available for testing.
• People whose cancer has come back or continued to grow after at least one prior systemic treatment (such as chemotherapy, with or without bevacizumab, or hormonal therapy) for advanced disease.
• People whose cancer can be measured on scans according to standard criteria (called RECIST 1.1).
• People who are reasonably well and able to carry out daily activities, as measured by a standard scale (ECOG score of 0, 1, or 2).
• People whose blood, liver, kidney, and heart are functioning well enough to meet specific laboratory test thresholds (confirm exact values with trial site).
• People with a normal heart rhythm reading on an ECG (a specific heart electrical measurement called QTc must be below 460 ms); this requirement does not apply to people with certain pre-existing heart conduction conditions (confirm with trial site).
• People who have recovered sufficiently from side effects of previous treatments (most side effects must be mild or resolved; some exceptions, such as hair loss or mild nerve-related symptoms, may be allowed).
• People of reproductive potential, and their male partners, who agree to use highly effective contraception during the trial and for one month after the last dose of the study drug (Avutometinib).

Who may not be able to join:

• People who have received any systemic cancer treatment within 4 weeks before the first dose of the study drug.
• People who have previously been treated with a MEK inhibitor or RAF inhibitor type of drug.
• People whose diagnosis is low-grade serous ovarian cancer (LGSOC).
• People with a history of another cancer that came back within the past 3 years (some exceptions may apply for certain low-risk skin cancers or early-stage cancers that were treated successfully — confirm with trial site).
• People whose treating doctor considers them suitable candidates for tumour-removal surgery; those people should have surgery before considering this trial.
• People who have had major surgery within 4 weeks, minor surgery within 2 weeks, or palliative radiotherapy within 1 week before the first dose of the study drug.
• People currently taking the blood-thinning medication warfarin (switching to a different type of blood thinner may be possible — confirm with trial site).
• People who have taken certain medications that strongly affect how the body processes drugs (known as strong CYP2C9 or CYP3A4 inhibitors or inducers) within 14 days before the first dose or during the trial.
• People who have taken certain other medications that interact with a drug transport system in the body (known as P-glycoprotein inhibitors or inducers) within 14 days before the first dose or during the trial.
• People with brain metastases (cancer spread to the brain) that are currently causing symptoms and require steroids or other active treatment (people with previously treated, stable, and symptom-free brain metastases may be considered — confirm with trial site).
• People who have had a confirmed, symptomatic COVID-19 infection within 28 days before the first dose of the study drug.
• People with an active hepatitis B, hepatitis C, or HIV infection that is currently active or requires treatment.
• People with an active skin disorder that has needed systemic (whole-body) treatment within the past year.
• People with a history of a serious muscle breakdown condition called rhabdomyolysis.
• People with certain eye conditions, including a history of glaucoma, retinal vein blockage, uncontrolled high blood pressure, uncontrolled diabetes, certain retinal problems, elevated eye pressure, corneal conditions, or other serious eye surface disorders.
• People with certain serious heart or lung conditions, including heart failure, a history of severe heart disease (Class III or IV), a heart attack in the past 6 months, unstable heart rhythm, unstable chest pain, or severe breathing obstruction.
• People who are unable to swallow tablets, or who have problems absorbing medications due to having had part or all of the stomach removed, or who have active inflammatory bowel disease.
• People with a known allergy or sensitivity to Avutometinib or any of its ingredients.
• People who are pregnant or breastfeeding.
• People with other serious medical conditions (including heart, stomach, lung, psychiatric, neurological, or genetic conditions) that the investigating doctor believes would put them at unacceptably high risk of harm.

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