drugset / Trial / NCT04641247

A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

NCT04641247

Phase 2 Recruiting 37 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelTreatment

Summary

This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.

Timeline

Start
2021-04-16
Primary completion
2026-12-28
Completion
2026-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Niraparib Small molecule Oral