Long-term niraparib treatment for people who completed a prior GSK/TESARO niraparib protocol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label extension provides continued access to niraparib for participants who completed a GSK/TESARO-sponsored parent protocol and are still receiving benefit. Participants who meet entry requirements continue on niraparib and are followed for long-term safety and adverse events. The study enrolls adults previously treated with niraparib (monotherapy or combination) and requires informed consent and contraception use for those of childbearing potential. Data collected will characterize tolerability and safety signals with extended exposure to niraparib.

Why it matters

Who can join: the full rules

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).

Where it's running

• GSK Investigational Site
  Encinitas, California, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  Atlanta, Georgia, United States Recruiting
• GSK Investigational Site
  Harvey, Illinois, United States Recruiting
• GSK Investigational Site
  Boston, Massachusetts, United States Recruiting
• GSK Investigational Site
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.