What is niraparib studying for ovarian cancer?

Niraparib is being studied to understand how it works as a maintenance treatment for ovarian cancer, particularly in women of African ancestry. Researchers want to see how genetic and environmental factors affect the treatment's effects. The University of Miami is leading this clinical trial.

Who may be eligible for this ovarian cancer clinical trial?

Women aged 18 or older who identify as Black or African American and have completed treatment for stage III or IV ovarian, fallopian tube, or primary peritoneal cancer may be eligible. They must have responded to platinum-based chemotherapy and meet certain health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this ovarian cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 4

Age: 18Years +

FEMALE

ID06412120

Study of Oral Niraparib as Maintenance Treatment for Ovarian Cancer in Black Women Including Those of African Ancestry

Led by University of Miami · Updated on 2026-08-05

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to understand the genetic and environmental factors, especially the degree of African ancestry, that may influence the effects of maintenance treatment in women with ovarian cancer. The study focuses on testing an investigational drug called niraparib, which blocks cancer cells from repairing their damaged genes, making it harder for them to grow and spread. Participants will receive niraparib as a maintenance therapy for up to 24 cycles, each lasting 28 days. The drug is taken daily by mouth at one of three doses determined by individual health factors. After finishing the treatment, participants will be followed for up to one year, making the total participation time about three years. During the study, participants will provide saliva, blood, and tumor samples for genetic testing. They will be monitored regularly for side effects, treatment response, and quality of life using questionnaires. Researchers will track the occurrence of adverse events and measure how long participants remain free from cancer recurrence. Safety and drug metabolism will be assessed over the study period.

CONDITIONS

Brief Title

Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Female aged 18 years or older who can understand study procedures and provide consent
Self-identify as Black, including those who also identify as Latino
Completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer
Have high-grade serous or high-grade endometrioid histology
Provide saliva and/or blood samples for genetic testing
Provide tumor tissue samples from surgery or biopsy
Achieved complete or partial clinical response to adjuvant treatment confirmed by CT scan within 8 weeks after last chemotherapy dose
Recovered to Grade 1 or less toxicity from prior treatments
No known allergy or contraindication to niraparib or its ingredients
Considered suitable candidates for maintenance niraparib therapy by their treating physician
Have adequate organ function meeting defined blood counts and liver/kidney function levels
Patients with HIV allowed if stable with controlled viral load and no recent AIDS-related infections
Not pregnant or breastfeeding, and if of childbearing potential, using effective contraception and having negative pregnancy tests
Agree to complete quality of life and patient-reported outcome questionnaires during the study

You will not qualify if you...

Histologies including low-grade serous carcinoma, grade 1 or 2 endometrioid adenocarcinoma, clear cell, mucinous, transitional cell, carcinosarcoma, undifferentiated, or dedifferentiated
History or current diagnosis of myelodysplastic syndrome or acute myeloid leukemia
Primary progressive or platinum-refractory disease
Increased bleeding risk from recent major injury or surgery
Current platelet disorders
Inability to swallow oral medication or gastrointestinal issues affecting absorption
Uncontrolled high blood pressure (systolic >140 mmHg or diastolic >90 mmHg)
Active second primary cancer
Pregnant, breastfeeding, or planning pregnancy during treatment and 180 days after
Received live vaccine within 30 days before treatment start (non-live COVID-19 vaccines allowed)
Recent transfusions or colony-stimulating factor treatments within 4 weeks before first dose
Recent radiotherapy affecting bone marrow or radiation within 1 week before treatment
Central nervous system diseases including brain metastasis or hemorrhage
Active or recent pneumonitis requiring steroids or immunomodulatory treatment within 90 days
Active hepatitis B or C infection
History of posterior reversible encephalopathy syndrome
Impaired decision-making capacity
Serious uncontrolled medical disorders, infections, or psychiatric conditions that prevent informed consent
Currently receiving cytotoxic, hormonal, or other cancer treatments

Research Team

Matthew Schlumbrecht, MD, MPH

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Study of Oral Niraparib as Maintenance Treatment for Ovarian Cancer in Black Women Including Those of African Ancestry

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria