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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

AEs, SAEs and AESI will be collected.

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
GlaxoSmithKline

1,345 total trials

What NCT04641247 shows while recruiting

NCT04641247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower).

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 names 20 study sites across 15 states, led by 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.

Similar trials for Breast Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04641247's enrollment target sits among peer trials

30 87th of 97 higher than 10 of 97 other Breast Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04641247, the US trial registry maintained by the National Library of Medicine. NCT04641247 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.