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NCT04641247 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Neoplasms and Ovarian Neoplasms, sponsored by GlaxoSmithKline.

Recruiting
Registry status
Phase 2
Development phase
30
Enrollment target
20
Study locations

NCT04641247 is a Phase 2 study of Breast Neoplasms and Ovarian Neoplasms that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 30 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT04641247, a Phase 2 study of Breast Neoplasms and Ovarian Neoplasms, is actively recruiting participants, sponsored by GlaxoSmithKline.

RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • DRUG Niraparib

Study Locations (20)

Other

  • GSK Investigational Site - Graz
  • GSK Investigational Site - Vienna
  • GSK Investigational Site - Odense C
  • GSK Investigational Site - Nantes

California

  • GSK Investigational Site - Encinitas
  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Whittier

Arizona

  • GSK Investigational Site - Tucson

Florida

  • GSK Investigational Site - Jacksonville

Georgia

  • GSK Investigational Site - Atlanta

Illinois

  • GSK Investigational Site - Harvey

Massachusetts

  • GSK Investigational Site - Boston

Michigan

  • GSK Investigational Site - Grand Rapids

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-04-16
Est. Completion 2026-11-13
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT04641247

The ClinicalTrials.gov registry entry for NCT04641247 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Niraparib is the first listed.

NCT04641247 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT04641247 about?

NCT04641247 is a clinical study titled "A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study". 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, ...

What is the current status of trial NCT04641247?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-04-16. Estimated completion is 2026-11-13.

What conditions does trial NCT04641247 study?

This clinical trial studies the following conditions: Breast Neoplasms, Ovarian Neoplasms.

What interventions are being tested in trial NCT04641247?

The interventions under investigation include: Niraparib (DRUG).

Who is sponsoring clinical trial NCT04641247?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04641247 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.