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 who have been confirmed by tissue testing to have serous endometrial cancer or another type of endometrial cancer
• People whose cancer is classified as stage III or IV
• For Cohort 1 (maintenance therapy with niraparib alone): People with serous endometrial cancer who completed at least 6 cycles of platinum-based chemotherapy after surgery and whose cancer responded or stayed stable; or people with serous endometrial cancer who had platinum-based chemotherapy after their first relapse and whose cancer responded or stayed stable — and who can start treatment within 12 weeks of their last chemotherapy
• For Cohort 2 (niraparib alone as treatment): People with serous endometrial cancer who have had more than 2 rounds of platinum-based chemotherapy and whose cancer has come back; or people with other types of endometrial cancer who have had more than 2 rounds of platinum-based chemotherapy and who have a BRCA gene mutation or a positive HRD test result (confirm with trial site)
• People who have previously had radiotherapy or hormone therapy
• People in Cohort 1 with a life expectancy of more than 6 months; people in Cohort 2 with a life expectancy of more than 4 months
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People willing to provide a blood sample for genetic testing related to BRCA status and DNA repair mutations
• People willing to provide a stored tumour tissue sample for additional genetic testing (this is optional)
• People whose recent blood test results meet all of the following: adequate white blood cell, platelet, and red blood cell levels; kidneys and liver functioning within acceptable ranges (specific values to be confirmed with the trial site)
• People who are not able to become pregnant, or who have a negative pregnancy test and agree to use effective contraception throughout the study — this includes people who have had a hysterectomy, removal of both ovaries or both fallopian tubes, are over 60, or are aged 40–60 and have been through menopause for more than 12 months with confirming hormone test results
• People willing to sign a consent form and follow the study plan
• People whose side effects from previous chemotherapy have settled to a mild or stable level before joining (with exceptions allowed for mild ongoing nerve-related symptoms or hair loss)

Who may not be able to join:

• People with a known allergy to niraparib (ZL-2306) or chemically similar medicines
• People whose cancer is classified as stage Ia with no invasion into the uterine muscle wall
• People with brain or spinal cord covering (pial) metastases that are causing symptoms and are not controlled — though people with spinal cord compression whose condition has been stable for at least 28 days after treatment may still be considered (confirm with trial site)
• People who had surgery within 3 weeks before starting the study, or who have not yet recovered from surgery
• People who received radiotherapy covering more than 20% of their bone marrow within 1 week before joining
• People diagnosed with another active or aggressive cancer within the past 2 years (fully treated skin cancers such as basal cell or squamous cell carcinoma are generally excepted)
• People who have ever been diagnosed with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) — serious blood or bone marrow disorders
• People with serious uncontrolled health conditions, including: uncontrolled nausea or vomiting or difficulty swallowing tablets; active infections such as HIV, hepatitis B, or hepatitis C; uncontrolled seizures, unstable spinal cord problems, or certain other neurological or mental health conditions; or immune system deficiency (other than having had the spleen removed)
• People with any other past or current condition, treatment, or abnormal test result that the trial team considers may affect study results or safety (confirm with trial site)
• People who received a platelet or red blood cell transfusion within 4 weeks before starting the study
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who have previously been treated with any PARP inhibitor medicine

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