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RecruitingPhase 2

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

An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study lets people keep taking niraparib and checks its safety over a longer time. It is for people who are taking niraparib in certain GlaxoSmithKline/TESARO studies and are benefiting from it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You understand the study steps and agree to join by signing a consent form.
  • You are willing and able to follow the visit schedule, treatment plan, and other study steps.
  • You are taking niraparib, alone or with another treatment, in a GlaxoSmithKline/TESARO study that has met its main study goal.
  • Your study doctor says you are benefiting from niraparib under the rules of your current study.
  • If you can become pregnant and are sexually active, you and your partner must agree to use effective birth control during treatment and for 180 days after your last dose.

Who can't join

  • You have permanently stopped niraparib in your current study for any reason.
  • Your niraparib treatment is on hold because of side effects that have not cleared up. You may join once they improve enough to restart treatment, if you meet all other study rules.
  • You are pregnant or plan to have a child during treatment or within 180 days after your last dose.
  • You are breastfeeding or plan to breastfeed during treatment or within 30 days after your last dose. You must not breastfeed or save breast milk for later use during this time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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).

Study sites (13)

AZ

CA

FL

GA

IL

MA

MI

NC

NJ

NY

OH