Phase 4 Ovarian 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:

• Women aged 18 or older who can understand the study procedures and agree to take part by signing a consent form.
• People who self-identify as Black, including those who also identify as Latino.
• People who have finished treatment for a newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.
• People whose cancer is a specific type, either high-grade serous or high-grade endometrioid.
• People willing to provide a saliva and/or blood sample for genetic testing related to a specific biological pathway (the Fanconi Anemia pathway).
• People able to provide a stored or fresh tumour tissue sample from their surgery or biopsy.
• People whose cancer showed a complete or partial response to chemotherapy, confirmed by a CT scan within 8 weeks of finishing their last chemotherapy dose.
• People who have recovered well from side effects of previous treatment (side effects must be mild or resolved).
• People who have no known allergy or sensitivity to the study drug, niraparib, or its ingredients.
• People whose treating doctor considers them a suitable candidate for maintenance therapy with niraparib.
• People whose blood test results show that the kidneys, liver, and blood cell counts are within acceptable ranges as defined by the trial (confirm specific values with the trial site).
• People living with HIV may be eligible if their immune cell count and virus levels are within certain ranges, they have not had certain HIV-related infections or cancers recently, and they have been on approved HIV treatment for more than 4 weeks before joining the trial (confirm specific criteria with the trial site).
• People who are not pregnant or breastfeeding, and who either cannot become pregnant or are using a highly effective form of contraception and agree not to donate eggs during the study period and for at least 180 days after the last dose of treatment.
• People willing to complete quality-of-life and patient-reported outcome questionnaires throughout the study.

Who may not be able to join:

• People whose cancer is a different type, such as low-grade serous, clear cell, mucinous, carcinosarcoma, or several other specific types listed in the trial criteria.
• People with a current or past diagnosis of certain blood or bone marrow disorders, specifically myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
• People whose cancer did not respond to or got worse during platinum-based chemotherapy.
• People at increased risk of bleeding, for example those who had a major injury or major surgery within the past 28 days.
• People currently diagnosed with a platelet disorder such as TTP or ITP.
• People who are unable to swallow tablets or who have a digestive condition that may prevent the medication from being absorbed properly.
• People with high blood pressure that has not been adequately treated or controlled.
• People currently diagnosed with a second, active cancer.
• People who are pregnant, currently breastfeeding, or planning to become pregnant during the study or within 180 days of the last treatment dose.
• People who have received a live vaccine within 30 days before the planned start of treatment (non-live COVID-19 vaccines are allowed).
• People who have had a blood transfusion or received certain blood-stimulating medications within 4 weeks before the first dose of the study treatment.
• People who have had radiation therapy covering a large portion of the bone marrow within 2 weeks, or any radiation therapy within 1 week, before starting the study.
• People who have cancer that has spread to the lining of the brain or spinal cord, or who have active or symptomatic brain involvement.
• People with current active lung inflammation (pneumonitis) or a history of pneumonitis requiring steroids or immune-related treatment within the past 90 days.
• People with an active hepatitis B or C infection.
• People with a prior history of a condition called posterior reversible encephalopathy syndrome (PRES) (confirm with trial site).
• People who are not able to make informed decisions for themselves.
• People with serious, uncontrolled medical conditions, uncontrolled infections, or certain psychiatric conditions that would prevent them from giving informed consent — specific examples include uncontrolled heart rhythm problems, a heart attack within the past 90 days, uncontrolled seizures, or certain other serious conditions (confirm with trial site).
• People currently receiving chemotherapy, hormonal therapy, or other cancer treatments.

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