Clinical Trial

Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Recruiting Phase 4

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.

Protocol Amendment History 6 changes

notable Primary completion pushed: 2029-06-08 -> 2029-07-28 2026-08-06

minor Completion pushed: 2031-06-08 -> 2031-07-28 2026-08-06

notable Primary completion moved earlier: 2029-08-01 -> 2029-06-08 2026-06-24

minor Completion moved earlier: 2031-08-01 -> 2031-06-08 2026-06-24

notable Primary completion pushed: 2029-06-01 -> 2029-08-01 2026-06-04

minor Completion pushed: 2031-06-01 -> 2031-08-01 2026-06-04

Trial Details

NCT Number	NCT06412120
Lead Sponsor	University of Miami Collaborators: GlaxoSmithKline
Conditions	Ovarian Cancer
Enrollment	70 participants
Start Date	2026-07-28
Primary Completion	2029-07-28 (estimated)
Study Completion	2031-07-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-05