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Recruiting NCT04641247

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

Phase II Interventional Ovarian Neoplasms Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Niraparib.
Who it may be relevant to
Registry conditions: Ovarian Neoplasms, Breast Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Austria, Canada, Denmark, France +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Niraparib
    Niraparib tablets or capsules will be given once a day via the oral route.

Primary outcome measures

  • Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) [Time frame: Up to 5 years]
  • Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status [Time frame: Up to 5 years]
  • Number of participants with clinically significant changes in hematology and clinical chemistry parameters [Time frame: Up to 5 years]
  • Number of participants with clinically significant changes in vital signs [Time frame: Up to 5 years]
  • Number of participants with clinically significant changes in physical examination [Time frame: Up to 5 years]
  • Number of participants with use of concomitant medications [Time frame: Up to 5 years]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 13 centers
  • GSK Investigational Site — Tucson
  • GSK Investigational Site — Encinitas
  • GSK Investigational Site — Los Angeles
  • GSK Investigational Site — Whittier
  • GSK Investigational Site — Jacksonville
  • GSK Investigational Site — Atlanta
  • GSK Investigational Site — Harvey
  • GSK Investigational Site — Boston
  • … and 5 more centers
Canada · 3 centers
  • GSK Investigational Site — Kelowna
  • GSK Investigational Site — Toronto
  • GSK Investigational Site — Montreal
Austria · 2 centers
  • GSK Investigational Site — Graz
  • GSK Investigational Site — Vienna
France · 2 centers
  • GSK Investigational Site — Nantes
  • GSK Investigational Site — Nice
Spain · 2 centers
  • GSK Investigational Site — Madrid
  • GSK Investigational Site — Madrid
Denmark · 1 center
  • GSK Investigational Site — Odense C
Israel · 1 center
  • GSK Investigational Site — Haifa
Italy · 1 center
  • GSK Investigational Site — Cremona

Identifiers

NCT: NCT04641247 · 213409 · 2020-002667-53 · 2023-506618-29

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗