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

{ "Long-term Niraparib Treatment for Ovarian and Breast Cancers", "This study is for people who are already taking niraparib for ovarian or breast cancer as part of a GlaxoSmithKline/TESARO-sponsored study. It's designed to let you continue receiving niraparib and help researchers understand its long-term safety. They will be looking at side effects (adverse events), changes in your overall health (ECOG performance status), and changes in your blood tests over up to 5 years. To join, you must be at least 18 years old, understand the study, and be willing to follow the study plan. The study aims to include 37 participants.", "design": "This is an interventional study with a planned enrollment of 37 participants. It is an extension study, meaning it follows participants from previous studies.", "commitments": "You will take niraparib tablets or capsules once a day by mouth. You will also need to attend scheduled visits and follow other study procedures for up to 5 years.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for up to 5 years to monitor adverse events, performance status, and blood test changes.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE2Ages 18+InterventionalTreatment

GlaxoSmithKline

~37 participants

Updated 2026-06-24 on ClinicalTrials.gov

What's tested:Niraparib

At a glance

Recruiting sites

18 of 25 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

Measured over Up to 5 years

+5 more outcomes measured

Conditions

Ovarian Neoplasms

Breast Neoplasms

Where it's being run

25 sites across 20 states

California3

Austria2

France2

Spain2

Arizona1

Florida1

Georgia1

Illinois1

Study leadership

GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)Up to 5 years
AEs, SAEs and AESI will be collected.
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance statusUp to 5 years
The performance status will be assessed using ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care) and Grade 4 (completely disabled). Number of participants with clinically significant changes in ECOG performance status will be summarized.
Number of participants with clinically significant changes in hematology and clinical chemistry parametersUp to 5 years
Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.
Number of participants with clinically significant changes in vital signsUp to 5 years
Number of participants with clinically significant changes in vital signs will be assessed.
Number of participants with clinically significant changes in physical examinationUp to 5 years
Number of participants with clinically significant changes in physical examination will be assessed.
Number of participants with use of concomitant medicationsUp to 5 years
Number of participants using concomitant medications will be assessed.

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