RecruitingPhase 4NCT06412120

Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Single-Arm, Prospective, Multicenter Study Evaluating Safety, Tolerability, and Metabolism of Niraparib as Maintenance Following Front-Line Treatment for Ovarian Cancer in Women of African Ancestry

Sponsor

University of Miami

Enrollment

70 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how the body processes niraparib, a cancer drug (PARP inhibitor), specifically in Black women who have completed treatment for advanced ovarian, fallopian tube, or peritoneal cancer. Black patients have historically been underrepresented in cancer drug trials, and this study aims to better understand drug metabolism in this population. **You may be eligible if...** - You are a female aged 18 or older who self-identifies as Black (including those who also identify as Latina) - You have completed treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer - You have a specific type of cancer (high-grade serous or high-grade endometrioid) - You are willing to provide blood or saliva samples for genetic analysis **You may NOT be eligible if...** - You do not self-identify as Black - You have not completed adjuvant treatment for this cancer - You have a different cancer type or stage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNiraparib

Niraparib will be administered orally (PO) daily as tablets at one of three possible dose levels, 100mg/day, 200mg/day or 300mg/day, based upon participant weight, platelet count, and certain drug combinations and conditions assessed at baseline.

Locations(3)

Broward Health

Fort Lauderdale, Florida, United States

University of Miami

Miami, Florida, United States

Ahmadu Bello University Teaching Hospital (ABUTH)

Zaria, Kaduna State, Nigeria

View Full Details on ClinicalTrials.gov

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NCT06412120

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