Long-term Study for Continued Niraparib Treatment in Participants from Previous Studies

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT04641247

Provider View

This study allows participants who were part of earlier niraparib studies to continue their treatment and helps researchers understand the long-term safety of the drug.

Patient Parameters

Program Overview

This global study is designed to provide ongoing access to the drug niraparib for participants who were part of previous studies sponsored by GlaxoSmithKline/TESARO. It aims to continue monitoring the long-term safety of niraparib for those who are still benefiting from the treatment.

Eligibility Criteria

Inclusion Criteria

  • You must understand the study procedures and agree to participate by signing a consent form.
  • You must be willing and able to attend scheduled visits and follow the treatment plan.
  • You must currently be receiving niraparib treatment in a previous GlaxoSmithKline/TESARO study that has met its main goals.
  • You must be benefiting from niraparib treatment as determined by the study doctor.
  • If you can have children and are sexually active, you and your partner must agree to use effective birth control during the study and for 180 days after the last dose.

Exclusion Criteria

  • You cannot participate if you have been permanently stopped from taking niraparib in the previous study.
  • You cannot join if you have unresolved side effects that have paused your niraparib treatment. You may join once these side effects are resolved.
  • You cannot be pregnant or planning to become pregnant while taking the study drug or for 180 days after the last dose.
  • You cannot be breastfeeding or planning to breastfeed within 30 days after the last dose of the study drug.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site85710TucsonArizona
GSK Investigational Site92024EncinitasCalifornia
GSK Investigational Site90048Los AngelesCalifornia
GSK Investigational Site90603WhittierCalifornia
GSK Investigational Site32224JacksonvilleFlorida
GSK Investigational Site30342AtlantaGeorgia
GSK Investigational Site60426HarveyIllinois
GSK Investigational Site02115BostonMassachusetts
GSK Investigational Site60637-1470Grand RapidsMichigan
GSK Investigational Site07962-1956MorristownNew Jersey

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