A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
Recruiting · NCT04641247 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
25 locations listed across 11 US states.
- GSK Investigational Site - Tucson, Arizona, United States
- GSK Investigational Site - Encinitas, California, United States
- GSK Investigational Site - Los Angeles, California, United States
- GSK Investigational Site - Whittier, California, United States
- GSK Investigational Site - Jacksonville, Florida, United States
- GSK Investigational Site - Atlanta, Georgia, United States
- GSK Investigational Site - Harvey, Illinois, United States
- GSK Investigational Site - Boston, Massachusetts, United States
- GSK Investigational Site - Grand Rapids, Michigan, United States
- GSK Investigational Site - Morristown, New Jersey, United States
- GSK Investigational Site - Lake Success, New York, United States
- GSK Investigational Site - Charlotte, North Carolina, United States
- GSK Investigational Site - Cleveland, Ohio, United States
- GSK Investigational Site - Cremona, Italy
- GSK Investigational Site - Graz, Austria
- GSK Investigational Site - Haifa, Israel
- GSK Investigational Site - Madrid, Spain
- GSK Investigational Site - Madrid, Spain
- GSK Investigational Site - Nantes, France
- GSK Investigational Site - Nice, France
- GSK Investigational Site - Odense C, Denmark
- GSK Investigational Site - Vienna, Austria
- GSK Investigational Site - Kelowna, British Columbia, Canada
- GSK Investigational Site - Toronto, Ontario, Canada
- GSK Investigational Site - Montreal, Quebec, Canada