You may be eligible if you:

• Self-identify as Black, African, and/or Afro-Caribbean
• Are a woman aged 18 or older
• Have been diagnosed with Stage III or IV high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal carcinoma
• Have completed primary treatment (surgery and platinum-based chemotherapy) and have a complete or partial response confirmed by CT scan
• Have an ECOG performance status of 0–2
• Do not have a known contraindication or hypersensitivity to niraparib

A full list of inclusion and exclusion criteria will be reviewed by your study doctor during the screening visit.

Niraparib is an oral tablet taken once daily. It belongs to a class of medicines called PARP inhibitors (poly ADP-ribose polymerase inhibitors). It works by blocking proteins that cancer cells need to repair their DNA. By doing so, it prevents cancer cells from repairing themselves, ultimately causing them to die.

Niraparib has been approved by the US FDA and regulatory authorities in more than 30 countries for use as maintenance treatment following platinum-based chemotherapy in ovarian cancer.

Landmark trials like PRIMA and NOVA — which led to niraparib’s approval — enrolled very few Black women (1.6% and 1.3%, respectively). Because women of African ancestry may have different genetic profiles, metabolism of niraparib, and cancer biology compared to women of European ancestry, it is unknown whether the drug behaves the same way in this population.

We also know that Black women with ovarian cancer carry higher rates of BRCA1/2 mutations than previously recognized, and that certain pharmacogenomic variants prevalent in populations of African ancestry may affect drug metabolism. This study is designed to fill these critical knowledge gaps and ensure equitable cancer care.

Total participation is approximately 3 years:

• Screening Period: Up to 30 days — eligibility tests and baseline assessments
• Treatment Period: Up to 24 months (2 years) — you take niraparib once daily and attend monthly visits
• Follow-Up Period: Up to 12 months (1 year) — 5 follow-up visits to monitor your long-term health

You may stop treatment earlier if your disease progresses, if you develop unacceptable side effects, or if you choose to withdraw your consent at any time.

Niraparib is taken as an oral tablet, once per day, preferably at night, with or without food. You should swallow the tablet whole with water — do not chew, crush, or split it.

Your starting dose will be determined by your weight and baseline platelet count:

• 300 mg/day — if your weight is ≥77 kg and your platelet count is ≥150,000/μL
• 200 mg/day — if your weight is <77 kg or your platelet count is <150,000/μL

Your study doctor may adjust your dose based on how you are tolerating treatment.

As with all medicines, niraparib can cause side effects. The most commonly reported side effects in previous trials include:

• Anaemia (low red blood cells)
• Thrombocytopenia (low platelet count)
• Neutropenia (low white blood cells)
• Nausea, constipation, vomiting
• Fatigue
• Headache and insomnia
• Elevated blood pressure
• Abdominal pain

A rare but serious risk is myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), which occurred in approximately 1.2% of patients in prior studies. Your study doctor will monitor you closely with regular blood tests, and dose adjustments are made if needed. You should report any new or worsening symptoms to the study team promptly.

Participation in this study is voluntary. You will not be paid for taking part; however, study-related tests, procedures, and the study medication (niraparib) will be provided at no cost to you during the study. Any expenses related to travel or other costs should be discussed with the study team. You will not lose any benefits to which you are otherwise entitled if you decide not to participate or choose to withdraw.

Yes. Your privacy is protected by applicable laws and regulations. Your personal data will be coded so that your name and identifying details are not used in study reports or publications. Only authorised study personnel, regulatory authorities, and the Institutional Review Board (IRB) / Research Ethics Committee (REC) may access your identifiable information for monitoring purposes. All data is stored securely.

Study visits are primarily monthly during the treatment period. At visits you may have:

• Blood tests (safety monitoring, pharmacokinetics, CA-125)
• Physical examination and vital signs
• Electrocardiogram (ECG)
• CT/MRI/PET imaging (at specified timepoints to assess disease status)
• Quality-of-life questionnaires (FOSI-8 and FACT-GP5)
• Pill diary review
• Pregnancy test (if applicable)

Some visits may be conducted remotely (by telephone or video) where permitted by the protocol.

Yes, under specific conditions. Participants with known HIV infection may be enrolled if they meet all of the following criteria:

• CD4 cell count ≥350/μL and viral load <400 copies/mL
• No history of AIDS-defining opportunistic infections within the past 12 months
• No history of HIV-associated malignancy in the past 5 years
• Currently on stable antiretroviral therapy per current NIH guidelines, started more than 4 weeks before study enrolment

Yes. Participation is entirely voluntary. You may withdraw from the study at any time without penalty and without affecting your standard medical care. If you decide to withdraw, please inform your study doctor so that appropriate follow-up care can be arranged. Withdrawing does not affect your rights as a patient.

The Bahamas site (Site 105) is managed by PeriomedCare Ltd in Nassau, Bahamas, in collaboration with the University of the West Indies — Nassau. Laboratory services are provided by Doctor’s Hospital, Nassau. The site has received ethics approval from the Public Hospital Authority Research Ethics Committee.

To enquire about participation or to be referred, please use the Contact form on this page.

If you experience any of the following serious symptoms, do not wait — go immediately to the nearest hospital emergency room. Do not attempt to contact the clinical team before seeking emergency care.

Serious symptoms that require immediate emergency attention include:

Bleeding — unusual or unexplained bruising, bleeding gums, blood in urine or stool, coughing or vomiting blood, or bleeding that will not stop. Niraparib can cause low platelet counts (thrombocytopenia), which increases your risk of serious bleeding.

Signs of severe infection — high fever (38.5°C / 101.3°F or above), chills, shaking, severe sore throat, pain when urinating, or a wound that is hot, swollen, or producing discharge. Niraparib can lower your white blood cell count (neutropenia), reducing your ability to fight infection.

Severe shortness of breath or chest pain — difficulty breathing at rest, chest tightness, or pain that spreads to your arm or jaw.

Very high blood pressure — sudden severe headache, vision changes, confusion, or nosebleeds that do not stop. Niraparib has been associated with hypertension.

Neurological changes — sudden confusion, seizures, loss of vision, difficulty speaking, or loss of consciousness. These may be signs of a rare but serious condition called Posterior Reversible Encephalopathy Syndrome (PRES).

Severe nausea, vomiting, or inability to keep fluids down for more than 24 hours.

Signs of severe anaemia — extreme fatigue, dizziness, rapid heartbeat, or fainting.

When you arrive at the emergency room, please tell the team the following:

You are enrolled in a clinical research study and are taking Niraparib (a PARP inhibitor) as part of your treatment. Tell them your dose and how often you take it, the time and date of your last dose, and any other medications you are currently taking.

Describe clearly what happened — when the symptom started, how quickly it developed, and any other factors you think may be relevant, such as recent illness, injury, vomiting, or missed doses.

Ask the emergency room team to contact a member of the clinical study team as soon as your condition is stable. The clinical team contact number is available on your study participation card, which you should carry with you at all times.

Do not stop taking your medication unless instructed to do so by a qualified medical professional.