A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice

Sponsor
Takeda
Study ID
NCT05021562
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The main aim of this study is to check for side effects from treatment with niraparib. 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.

Key Dates

Start date
Sep 13, 2021
Status verified
Apr 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
354 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Number of Participants with Adverse Event of Myelosuppression [ Time Frame: 1 year ]

Related Studies