Study Evaluating Safety, Tolerability, and Metabolism of Niraparib (NCT06412120) | Clinical Trial Compass
RecruitingPhase 4
Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
United States, Nigeria70 participantsStarted 2026-06-01
Plain-language summary
The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Participant must be female ≥18 years of age, able to understand study procedures, and agree to participate in the study by providing written informed consent.
✓. Self-identify as Black. Please note that individuals who identify as Latino are eligible to participate so long as they also self-identify as Black.
✓. Participant has completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.
✓. Participant must have high-grade serous or high-grade endometrioid histology.
✓. Participant must provide saliva and/or blood specimens for assessment of germline mutation(s) in the Fanconi Anemia pathway.
✓. Participant must provide formalin-fixed, paraffin-embedded (FFPE) or fresh tumor specimen from initial cytoreductive surgery (primary debulking) or initial pre-treatment core biopsy (if neoadjuvant chemotherapy (NACT) received; tumor obtained from interval cytoreduction acceptable if pre-treatment biopsy not obtained).
✓. Participant must have had a complete or partial clinical response to adjuvant treatment as confirmed by CT scan within 8 weeks after completion of the last dose of platinum-based chemotherapy.
✓. Participant must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments.
Exclusion criteria
✕. Any of the following histologies: low-grade serous carcinoma, grade 1 or 2 endometrioid adenocarcinoma, clear cell, mucinous, transitional cell, carcinosarcoma, undifferentiated, dedifferentiated
What they're measuring
1
Proportion of Participants Experiencing Any Grade or Grade 3 or Higher of the Most Common Adverse Events (AEs) Previously Reported in the PRIMA trial (NCT02655016).
✕. Participant is at an increased risk of bleeding due to concurrent conditions (eg, major injuries or major surgery within the past 28 days before start of study treatment).
✕. Current diagnosis of platelet disorder (eg, thrombotic thrombocytopenic purpura (TTP), immune thrombocytopenia (ITP))
✕. Inability to swallow orally administered medication or has a gastrointestinal disorder likely to interfere with absorption of the study medication
✕. Participants that have systolic blood pressure (SBP\])\>140 mmHg or diastolic blood pressure (DBP)\>90 mmHg that has not been adequately treated or controlled.