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:

• People who have been confirmed by lab testing (through cell or tissue samples) to have endometrial cancer that has come back, spread to other parts of the body, or has stopped responding to standard treatments — or for which no standard treatment exists.
• People in certain groups within the trial (Cohort 1A second stage, Cohorts 3, 6, and 7) must have a specific type confirmed by tissue testing: either endometrioid endometrial cancer, or endometrial carcinosarcoma with an endometrioid component.
• People whose cancer tests positive for estrogen receptors (ER-positive), meaning at least 1% of the cancer cells show a specific protein marker when tested in a certified laboratory.
• People who have at least one tumour or lesion that can be measured using standard imaging methods such as CT scan or MRI.
• People aged 18 or older.
• People who are generally well enough to carry out light activity and care for themselves (this is measured using a standard scale called the ECOG scale, with a score of 0 or 1).
• People whose blood test results show that the bone marrow, liver, and kidneys are functioning within acceptable ranges as defined by the trial.
• For Cohorts 6 and 7: people whose ovaries are no longer functioning, or who agree to start hormonal suppression treatment if ovarian function is still present.
• People who are able and willing to use an approved form of contraception during treatment and for 3 months after the last dose (for example, an intrauterine device, or a barrier method such as condoms used together with a spermicide).
• People who are able to understand the study and are willing to sign a consent form.
• People who are able to swallow and keep down oral (tablet or capsule) medication.
• People who have previously received any number of prior cancer treatments — there is no limit on how many prior therapies are allowed.
• People who have stored tumour tissue samples available (such as a preserved tissue block or slides from a previous biopsy), which only needs to be confirmed as available — it does not need to be sent to the research team before joining.
• For Cohorts 6 and 7: people whose blood sugar levels fall within specific ranges (HbA1c of 6.4% or below and fasting blood glucose of 140 mg/dL or below).
• For Cohorts 6 and 7: people whose tumour has a normal (wildtype) version of the TP53 gene, confirmed by laboratory testing.
• For Cohort 7: people who have previously been treated with a CDK4/6 inhibitor and whose cancer then continued to grow or spread (as determined by the trial doctor). People who stopped CDK4/6 inhibitor therapy because they could not tolerate it are not eligible for this cohort.

Who may not be able to join:

• People who have had chemotherapy, immunotherapy, another experimental treatment, or major surgery within 4 weeks before starting the trial (or within 6 weeks for certain specific chemotherapy agents). Prior hormonal therapy is allowed with no required waiting period.
• People who have received a type of targeted therapy called a tyrosine kinase inhibitor (TKI) within a certain time period before joining (based on how long that drug stays active in the body).
• People who have had radiotherapy within 2 weeks before starting the trial.
• People who have previously been treated with CDK4/6 inhibitors (such as abemaciclib), except in Cohort 7, where prior CDK4/6 inhibitor treatment is required.
• People currently receiving the medication metformin, if they are enrolling in Cohort 3.
• People who have a digestive system condition that could significantly affect how the body absorbs the study drugs.
• People who have cancer that has spread to the brain.
• People who have had a significant allergic reaction to a drug that is chemically similar to any of the study drugs.
• People who need to take certain medications that are known to strongly interact with the study drugs (specifically strong CYP3A4 inducers or inhibitors), unless a suitable alternative medication can be arranged before starting the trial.
• People who have serious, uncontrolled health conditions, including active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health or personal circumstances that would make it difficult to follow the trial requirements.
• People who are currently taking or expected to need medications known to affect the heart's electrical rhythm in a specific way (QT-prolonging drugs).
• People who have had a heart attack, unstable chest pain (angina), or a heart procedure (such as stenting or angioplasty) within the 6 months before joining.
• People who are pregnant, as the study drugs may harm an unborn baby. People who are breastfeeding must stop breastfeeding before joining the trial.
• People who have a history of another cancer, with some exceptions: those who have been cancer-free for at least 5 years, those considered by their doctor to be at low risk of their previous cancer returning, or those diagnosed within the past 5 years with certain low-risk skin cancers or early-stage breast or cervical cancer that have been treated.
• People who are known to be HIV-positive, due to an increased risk of serious infection with the study drugs.
• People who have high blood pressure that has not been controlled despite treatment (specifically, a reading consistently above 150/90 mmHg).
• For Cohorts 6 and 7: people whose heart electrical test (ECG) cannot be properly read, or whose QT interval measurement (a specific heart rhythm reading) is above the acceptable level.
• For Cohorts 6 and 7: people with type 1 diabetes, or type 2 diabetes that is not well controlled.
• For Cohorts 6 and 7: people who have previously received treatments that target a specific cell signalling pathway called the PI3K pathway — with a limited exception allowing up to 10 participants per cohort who have had prior treatment with a related drug called an mTOR inhibitor (such as everolimus).

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