Phase 3 Ovarian 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 newly diagnosed with stage III or IV ovarian cancer (including ovarian, fallopian tube, or primary peritoneal cancer) that has been confirmed by a pathology report, and is one of these types: high grade serous, high grade endometrioid, or another epithelial type with a BRCA1 or BRCA2 gene mutation
• People whose cancer testing shows either a harmful or likely harmful change (mutation) in the BRCA1 or BRCA2 gene, confirmed by a lab report — OR — people whose BRCA1/2 genes are normal but whose tumour has been found to have a DNA repair deficiency (called HRD), confirmed by a certified laboratory
• People who have had surgery to remove as much of the cancer as possible (either before or after chemotherapy)
• People who have completed a first course of platinum-based chemotherapy, consisting of at least 4 and no more than 9 cycles, before joining the trial
• People whose cancer showed at least a partial response to chemotherapy (meaning the cancer did not grow or spread during treatment), in the opinion of the treating doctor
• People who had brain metastases that were treated, provided that follow-up brain scans show no sign of the cancer growing there after chemotherapy
• People who are being enrolled at least 3 weeks but no more than 12 weeks after their last dose of platinum chemotherapy
• People who have never previously been treated with a PARP inhibitor drug (such as olaparib, niraparib, or rucaparib)
• People aged 18 or older
• People with a general health and activity level rated at 2 or below on a standard medical scale (meaning they are able to carry out basic self-care, even if not able to do active work) (confirm with trial site)
• People who are not pregnant and not breastfeeding
• People whose blood test results meet the following minimums: white blood cell count, platelet count, haemoglobin level, and kidney and liver function all within acceptable ranges as defined by the trial (confirm with trial site for specific values)
• People with a history of heart disease who are assessed as having heart function rated at class 2B or better on a standard heart health scale (confirm with trial site)
• People who are able to swallow tablets or capsules

Who may not be able to join:

• People who have an active infection currently requiring intravenous (IV) antibiotics
• People who currently have an abscess in the abdomen, an abnormal opening (fistula) in the abdomen or pelvis that has not been surgically diverted, a hole in the bowel, a bowel blockage, or who need a tube placed through the nose or stomach for drainage
• People who are unable to swallow medication taken by mouth
• People with a history of a blood or bone marrow disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML)
• People who have previously had an allogeneic bone marrow transplant (a transplant using donated bone marrow)
• People currently taking certain medications that strongly or moderately affect the way the body processes the trial drug (known as strong or moderate CYP3A inducers) (confirm with trial site)
• People with a known allergy or sensitivity to olaparib or any of its ingredients

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