A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice
NCT ID: NCT05021562
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
354 participants
OBSERVATIONAL
2021-09-13
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
During the study, participants with ovarian cancer will take capsules of niraparib (Zedula) once a day according to their clinic's standard practice. The study doctors will check for side effects from niraparib for 1 year after treatment starts.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Niraparib 200-300 milligrams (mg)
Arm description: Niraparib 200 mg, capsules, orally, once daily. For adult participants weighing 77 kilograms (kg) or more and with platelet count 150,000/mcrL or higher before the first dose of this drug, niraparib 300 mg, capsules, orally, once daily.
Niraparib
Niraparib capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Niraparib
Niraparib capsules
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ovarian cancer patients after initial chemotherapy (maintenance therapy)
* Patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy)
* Recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects.
Exclusion Criteria
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Takeda Selected Site
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain more information on the study, click here/on this link
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
jRCT2031210289
Identifier Type: REGISTRY
Identifier Source: secondary_id
Niraparib-4001
Identifier Type: -
Identifier Source: org_study_id