Phase 2 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 are able to understand the study, agree to take part, and sign a written consent form
• People who are female and aged 18 years or older
• People who have been newly diagnosed with a specific type of ovarian, primary peritoneal, or fallopian tube cancer (high-grade serous or grade 3 endometrioid type), confirmed by tissue testing, and who are receiving their first course of treatment
• People whose cancer is classified as Stage III or IV according to international gynaecological cancer staging guidelines, including those who received chemotherapy before surgery
• People who have completed at least 4 cycles of platinum-based chemotherapy (such as carboplatin, cisplatin, or oxaliplatin), whose tumours have shown a complete or significant response to that treatment (no single lesion larger than 1 cm), and whose CA-125 blood marker is either within the normal range or has dropped by 90% and remained stable — and who are able to begin the study drug within 12 weeks of finishing chemotherapy
• People who are post-menopausal (no periods for more than 1 year), have been surgically sterilised, or are willing to use adequate contraception or abstain from intercourse and agree not to donate eggs for reproduction from the time of enrolment until 6 months after the last dose of treatment; people who could potentially become pregnant must have a negative pregnancy test within 3 days before the first dose
• People who are generally well enough to carry out light activity and care for themselves (a standard measure of physical functioning, rated 0 or 1 on a recognised scale)
• People whose blood and organ function results meet the required levels at enrolment, including adequate white blood cell counts, platelet counts, haemoglobin, kidney function, and liver function (confirm specific values with the trial site)
• People with high blood pressure whose blood pressure is adequately treated and under control before starting treatment
• People who are able to swallow and take oral (by mouth) medications
• People who agree to provide blood samples before the first cycle of treatment, then weekly for the first month, and at other points as outlined in the study schedule

Who may not be able to join:

• People under 18 years of age
• People who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after finishing treatment
• People who have a known allergy or sensitivity to niraparib or any of its ingredients
• People who have previously received a type of drug called a PARP inhibitor, or who have taken part in a clinical trial where a PARP inhibitor was used in one of the study groups
• People who are currently enrolled in another investigational (research) trial
• People who have received another experimental therapy within 4 weeks, or within 5 half-lives of that drug (whichever is the longer period), before joining this trial
• People who experienced severe or long-lasting (more than 4 weeks) blood-related side effects or severe fatigue from previous cancer treatment
• People with a known history of, or test results suggesting risk of, a blood cell disorder called myelodysplastic syndrome or a related blood cancer
• People who are currently taking other medications that are not permitted alongside the study drug
• People who have had major surgery within 3 weeks before starting the study, or who have not yet fully recovered from a previous surgery
• People who have had fluid drained from the abdomen within 4 weeks before starting treatment
• People who have received radiotherapy to a large area of bone marrow within 2 weeks, or any other radiotherapy within 1 week, before starting the study
• People who have received a blood transfusion (red blood cells or platelets) within 4 weeks before starting treatment
• People who are planning to donate blood during the study or within 90 days after finishing treatment
• People who have been diagnosed with another invasive cancer (other than ovarian cancer) within the 2 years before joining, except for certain treated skin cancers
• People with uncontrolled cancer that has spread to the brain or the lining of the brain — those with treated and stable brain involvement may be considered (confirm with trial site)
• People with serious, uncontrolled medical conditions, non-cancer-related systemic illness, or an active uncontrolled infection, including people with HIV who are considered at high risk for serious outcomes
• People with any condition, treatment, or abnormal test result that could interfere with study results or their ability to participate for the full duration of the study (such as certain blood disorders)
• People who have a weakened immune system (people who have had their spleen removed are still considered)
• People with known active liver disease such as hepatitis B or C, or active bile duct disease (certain exceptions may apply — confirm with trial site)
• People whose heart rhythm test (ECG) shows a specific electrical delay in the heart (QT interval greater than 470 milliseconds) at the screening stage
• People who are known to carry a BRCA1 or BRCA2 gene mutation (as those individuals routinely receive a different treatment at the trial site); people whose BRCA status is unknown are not excluded
• People with a history of a specific brain condition called posterior reversible encephalopathy syndrome (PRES)
• People who have received a live vaccine within 30 days before the planned start of treatment
• People with digestive system problems that may reduce the absorption of oral medications
• People with significant heart or cardiovascular disease
• People whose blood test results are being repeatedly re-tested with the aim of eventually meeting the eligibility criteria
• People who are receiving blood transfusions specifically to reach the blood count levels required for eligibility

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