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New treatment option for Ovarian Neoplasms
Official title A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
ClinicalTrials.gov ID: NCT04641247
What this study is testing
What is Niraparib?
Niraparib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ovarian neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Encinitas, California, United States
- Los Angeles, California, United States
- Whittier, California, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Harvey, Illinois, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Morristown, New Jersey, United States
- Lake Success, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Graz, Austria
- Vienna, Austria
- Kelowna, British Columbia, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Odense C, Denmark
- Nantes, France
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Encinitas, California, United States; Los Angeles, California, United States; Whittier, California, United States; Jacksonville, Florida, United States; Atlanta, Georgia, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.