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Study of Niraparib for Ovarian Cancer in Black Women

This study is looking at an investigational medicine called niraparib for women with ovarian cancer. Niraparib works by blocking cancer cells' ability to repair their genes, which can make it harder for them to grow and spread. Researchers want to understand how genetic and environmental factors, specifically African ancestry, might affect how well niraparib works and what side effects it causes. You might be eligible if you are a woman aged 18 or older with ovarian cancer and self-identify as Black. The study will measure the proportion of participants who experience common side effects previously seen with niraparib over up to three years. The study aims to enroll 70 participants.

Study design
This interventional study plans to enroll 70 participants. Niraparib will be given by mouth daily at one of three dose levels.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years to monitor for adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06412120

Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Miami
~70 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Niraparib

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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).
Measured over Up to 3 years

Conditions

Ovarian Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal Cancer

Where it's being run

4 sites across 2 states
Florida3
Kaduna State1

Study leadership

  • Matthew Schlumbrecht, MD · PRINCIPAL_INVESTIGATOR · University of Miami
  • Sophia HL George, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Matthew Schlumbrecht, MD, MPH
[email protected]
305-243-2233
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Platelets ≥ 100 platelets × 10\^9/L
Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN), \<5× in patients with known liver metastases
Serum total bilirubin ≤ 1.5 × ULN
1.5-3.0 × ULN may be included with appropriate starting dose adjustment to 200 mg daily.
Creatinine \<1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥50 mL/min by Cockcroft-Gault
Depending on scenario, glomerular filtration rate (GFR) 30-49 mL/min can be permissible. 12. Patients with known human immunodeficiency virus (HIV) are allowed if they meet all the following criteria:
Cluster of differentiation 4 (CD4) ≥350/μL and viral load \<400 copies/mL
No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months before enrollment
No history of HIV-associated malignancy for the past 5 years. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV started \>4 weeks before study enrollment. 13. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:
Is not a woman of childbearing potential (WOCBP), or
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year) from the Screening Visit through at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment, and
A WOCBP must have a negative test result from a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 72 hours before treatment. Additional periodic testing should be carried out according to the protocol.

What this trial measures

  • 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).Up to 3 years

    The proportion of participants in this study experiencing any grade or grade 3 or higher of the most common adverse events (AEs), of any treatment attribution, as those previously reported in the PRIMA Trial (NCT02655016). Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0. The most common adverse events previously reported include: Anemia, nausea, thrombocytopenia, constipation, fatigue, neutropenia, headache, insomnia, vomiting, abdominal pain, and hypertension.