Study on the Safety, Tolerability, and Effects of Niraparib in Women with Ovarian Cancer

Inclusion Criteria

• Women aged 18 or older who can understand the study and agree to participate.
• Identify as Black, including those who also identify as Latino.
• Have completed initial treatment for stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.
• Have high-grade serous or endometrioid cancer.
• Willing to provide saliva or blood samples for genetic testing.
• Able to provide a tumor sample from initial surgery or biopsy.
• Showed a positive response to initial treatment as confirmed by a CT scan.
• Recovered from previous treatments with minimal side effects.
• No known allergies to niraparib.
• Considered suitable for niraparib maintenance therapy by their doctor.
• Have adequate organ function based on specific blood tests.
• HIV-positive patients can participate if their condition is stable and controlled.
• Women must not be pregnant or breastfeeding and must use effective birth control during the study.
• Agree to complete quality of life and patient-reported outcome surveys during the study.

Exclusion Criteria

• Have certain types of ovarian cancer not included in the study.
• Have a history or current diagnosis of specific blood disorders like MDS or AML.
• Have cancer that did not respond to initial platinum-based treatment.
• Have a high risk of bleeding or a current platelet disorder.
• Cannot swallow pills or have a digestive issue affecting medication absorption.
• Have high blood pressure that is not controlled.
• Have another active cancer.
• Are pregnant, breastfeeding, or planning to become pregnant during the study.
• Have received a live vaccine recently, except for non-live COVID-19 vaccines.
• Have had recent blood transfusions or certain growth factors.
• Have had recent extensive radiation therapy.
• Have certain brain or nervous system conditions.
• Have active lung inflammation or a history of severe lung issues.
• Have active hepatitis B or C.
• Have a history of certain brain conditions like PRES.
• Have impaired decision-making ability.
• Have serious, uncontrolled medical conditions or infections.
• Are currently receiving other cancer treatments.