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RECRUITING
NCT06412120
PHASE4

Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Sponsor: University of Miami

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-06-01

Completion Date

2031-06-01

Last Updated

2026-03-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

Niraparib

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 (2)

Broward Health

Fort Lauderdale, Florida, United States

University of Miami

Miami, Florida, United States