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Cancer drug niraparib gets Long-Term safety check in extension trial

NCT ID NCT04641247

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study offers continued access to niraparib, a daily oral cancer drug, for up to 37 patients with ovarian or breast cancer who have already completed a prior niraparib trial and are still benefiting. The main goal is to monitor long-term safety, including side effects and changes in daily functioning. Participants will continue their current niraparib dose and be followed for any health issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Niraparib (a targeted cancer drug taken as a daily pill)
What this could lead to
If successful, this study could confirm that long-term niraparib is safe and continues to control ovarian or breast cancer, offering a maintenance treatment option.
What could go wrong
This is a small, open-label extension study (37 participants) focused on safety, not on proving the drug works better. It only includes people who already tolerated niraparib, so results may not apply to all patients. Side effects like fatigue, nausea, or blood issues remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 37 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent. * Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures. * Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline/TESARO-sponsored study that has fulfilled the requirements for the primary objective. * Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements. * Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug. Exclusion Criteria: * Participant has been permanently discontinued from niraparib treatment in the parent study for any reason. * Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume. * Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).

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Conditions

The condition(s) this trial relates to.

breast neoplasm ovarian cancer ovarian neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms Ovarian neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    COMPLETED

    Tucson, Arizona, 85710, United States

  • GSK Investigational Site

    RECRUITING

    Encinitas, California, 92024, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90048, United States

  • GSK Investigational Site

    COMPLETED

    Whittier, California, 90603, United States

  • GSK Investigational Site

    COMPLETED

    Jacksonville, Florida, 32224, United States

  • GSK Investigational Site

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • GSK Investigational Site

    RECRUITING

    Harvey, Illinois, 60426, United States

  • GSK Investigational Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • GSK Investigational Site

    RECRUITING

    Grand Rapids, Michigan, 60637-1470, United States

  • GSK Investigational Site

    RECRUITING

    Morristown, New Jersey, 07962-1956, United States

  • GSK Investigational Site

    RECRUITING

    Lake Success, New York, 11042, United States

  • GSK Investigational Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    COMPLETED

    Cleveland, Ohio, 44195, United States

  • GSK Investigational Site

    RECRUITING

    Graz, A-8036, Austria

  • GSK Investigational Site

    RECRUITING

    Vienna, 1090, Austria

  • GSK Investigational Site

    RECRUITING

    Kelowna, British Columbia, V5Z 4E6, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    COMPLETED

    Odense C, 5000, Denmark

  • GSK Investigational Site

    COMPLETED

    Nantes, 44202, France

  • GSK Investigational Site

    COMPLETED

    Nice, 06189, France

  • GSK Investigational Site

    RECRUITING

    Haifa, 3109601, Israel

  • GSK Investigational Site

    RECRUITING

    Cremona, 26100, Italy

  • GSK Investigational Site

    RECRUITING

    Madrid, 28040, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28046, Spain

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