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 diagnosed with uterine serous carcinoma (a type of uterine cancer) that has come back or has not gone away, confirmed by a lab test on tumour tissue.
• People who have at least one tumour that can be measured using standard imaging criteria.
• People who have previously received at least one chemotherapy treatment that included platinum-based drugs for advanced or spread uterine serous carcinoma — or people whose early-stage cancer came back within 12 months of receiving platinum-based chemotherapy after surgery.
• People whose tumour has been tested for certain genetic markers (MSI or MMR status), and if the tumour showed specific results (MSI-high or MMR-deficient), people who have already received a specific type of immunotherapy (a PD-1 or PD-L1 checkpoint inhibitor) or have been assessed as not suitable for that immunotherapy.
• People aged 18 or older.
• People with a reasonable level of general physical functioning (confirm with trial site for exact criteria).
• People whose blood counts and organ function meet specific minimum levels, including adequate white blood cells, haemoglobin, platelets, liver function, and kidney function (confirm with trial site for exact values).
• People who are willing to provide stored tissue samples for research.
• People who have a tumour site that can be safely biopsied and are willing to have biopsies taken before and during treatment.
• People living with HIV who are on effective antiviral treatment with an undetectable viral load within the last 6 months, provided their antiviral medication does not strongly interact with the study drug.
• People who have had brain metastases (cancer that spread to the brain) that have already been treated, with no signs of the cancer growing back in the brain on follow-up scans.
• People with a new or growing brain tumour may be considered eligible only if the treating doctor determines that immediate brain-specific treatment is not needed and is unlikely to be needed during the first two cycles of the study treatment.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to affect the safety or results of this trial.
• People who are able to use adequate contraception (hormonal, barrier methods, or abstinence) before and throughout the study, as the effects of the study drug on an unborn baby are unknown.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have received chemotherapy, radiation, or another experimental treatment within 3 weeks before starting the study drug (or within 6 weeks for certain specific chemotherapy agents), or hormonal therapy within 2 weeks before starting.
• People who are still experiencing significant side effects (above a mild level) from previous cancer treatments, with the exception of hair loss.
• People currently taking part in another clinical trial for this condition.
• People who have previously received a specific type of cancer drug that targets cell cycle checkpoint proteins (such as Chek1, Wee1, or ATR inhibitors).
• People who have had a serious allergic reaction to drugs that are chemically similar to the study drug.
• People currently taking medications that are known to strongly interact with the study drug through a specific liver enzyme pathway (CYP3A4) — a doctor or pharmacist can help identify whether a current medication falls into this category.
• People who are pregnant, as the study drug may harm an unborn baby.
• People who are breastfeeding, as the potential risk to nursing infants is unknown.
• People of childbearing potential who are not willing or able to use reliable contraception for two weeks before starting the study, throughout the treatment period, and for a defined period after the last dose.
• People who have had major surgery within 28 days, or minor surgery within 7 days, before starting the study treatment (placement of a port for medication delivery within 7 days may be acceptable — confirm with trial site).
• People who are unable to swallow oral (tablet/capsule) medication, or who have severe nausea and vomiting, a feeding tube, are receiving nutrition through a drip directly into a vein, or are dependent on IV fluids.
• People who are currently using herbal supplements (including but not limited to cannabis, St. John's wort, ginkgo biloba, ginseng, and others), or who are unwilling to stop taking them at least 7 days before starting the study drug.
• People with a known history of heart disease or who have been treated with heart-damaging drugs, who are assessed as having a more significant level of heart-related functional limitation (confirm with trial site for exact classification criteria).
• People with known cancer that has spread to the lining surrounding the brain and spinal cord (leptomeningeal disease).

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