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NCT02655016 · ClinicalTrials.gov registry record · Phase 3

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

A Phase 3 study of Ovarian Neoplasms, sponsored by Tesaro.

Active
Registry status
Phase 3
Development phase
733
Enrollment target
20
Study locations

NCT02655016 is a Phase 3 study of Ovarian Neoplasms that is active but no longer recruiting, run by Tesaro. The registered enrollment target is 733 participants, above the 349-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT02655016, a Phase 3 study of Ovarian Neoplasms, is active but no longer recruiting, sponsored by Tesaro.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
733 participants
Enrollment target
20
Study locations

Study Summary

This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

Conditions Studied

Ovarian Neoplasms

Interventions

  • DRUG Placebo
  • DRUG Niraparib

Study Locations (20)

Arizona

  • GSK Investigational Site - Tempe
  • GSK Investigational Site - Tucson
  • GSK Investigational Site - Tucson

California

  • GSK Investigational Site - San Francisco
  • GSK Investigational Site - San Francisco
  • GSK Investigational Site - Santa Rosa

Florida

  • GSK Investigational Site - Jacksonville
  • GSK Investigational Site - Miami

Georgia

  • GSK Investigational Site - Atlanta
  • GSK Investigational Site - Savannah

Indiana

  • GSK Investigational Site - Indianapolis
  • GSK Investigational Site - Indianapolis

Louisiana

  • GSK Investigational Site - Covington
  • GSK Investigational Site - New Orleans

Maryland

  • GSK Investigational Site - Baltimore
  • GSK Investigational Site - Rockville

Connecticut

  • GSK Investigational Site - New Haven

Trial Details

FieldValue
Enrollment Target 733 participants
Start Date 2016-07-11
Est. Completion 2026-05-29
Phase Phase 3

Sponsor

Tesaro

26 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02655016

The ClinicalTrials.gov registry entry for NCT02655016 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 733 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 349-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (110% higher). The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ovarian Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02655016 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Arizona, California, Florida.

Frequently Asked Questions

What is clinical trial NCT02655016 about?

NCT02655016 is a clinical study titled "A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy". This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome me...

What is the current status of trial NCT02655016?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 733 participants. The study started on 2016-07-11. Estimated completion is 2026-05-29.

What conditions does trial NCT02655016 study?

This clinical trial studies the following conditions: Ovarian Neoplasms.

What interventions are being tested in trial NCT02655016?

The interventions under investigation include: Placebo (DRUG), Niraparib (DRUG).

Who is sponsoring clinical trial NCT02655016?

This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02655016 being conducted?

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

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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.