Phase 1 Endometrial Cancer Trial, Recruiting

Written by an AI model from the 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 an advanced solid tumour that has been confirmed by laboratory testing to carry a specific genetic change called a PIK3CA mutation, found in a blood and/or tumour sample.
• People with PIK3CA-mutated endometrial (womb) cancer may be eligible for one group in the trial (Phase 1b Cohort 1).
• People with a type of breast cancer described as hormone receptor-positive and either HER2-negative or HER2-low may be eligible for another group (Phase 1b Cohort 2), based on specific testing results meeting recognised guidelines.
• People with other solid tumours — including head and neck cancers, other gynaecological cancers, or bowel cancers with a PIK3CA mutation — may be eligible for a third group (Phase 1b Cohort 3), provided their cancer does not fit into the first two groups.
• People who have already received previous cancer treatments, or whose treating doctor has determined that standard first-line treatment is not appropriate for their condition.
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1).
• People who are in good general health, rated as fully active or able to carry out light work (ECOG Performance Status 0 or 1).
• People whose recent blood test results (including blood chemistry and blood counts) fall within acceptable limits set by the trial.
• People whose side effects from any previous cancer treatment have largely resolved to mild or baseline levels before joining the trial.
• People whose heart pumping function (ejection fraction) is measured at 50% or above.

Who may not be able to join:

• People who have received certain chemotherapy, other anticancer treatments, or radiotherapy within specific timeframes before the trial starts (confirm with trial site for exact timeframes).
• People who have had major surgery (such as abdominal surgery) within 4 weeks before starting the trial.
• People who have received radiotherapy within 2 weeks before starting the trial.
• People with a significant heart condition.
• People who are receiving or plan to receive long-term treatment (4 or more consecutive weeks) with steroid medications such as prednisone at doses higher than what the body naturally produces (above the equivalent of 20 mg per day of prednisone).
• People diagnosed with Type 1 diabetes, or Type 2 diabetes that is not well controlled (based on specific blood sugar and HbA1c test results), with the exception that some non-insulin diabetes medications may be permitted (confirm with trial site).
• People whose previous genetic tumour testing showed certain other mutations in genes including PTEN, AKT, HRAS, KRAS, NRAS, EGFR, or BRAF.

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