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

Takeda

Status: Active, not recruiting

Conditions: Ovarian Cancer

Treatments: Drug: Niraparib

Study type: Observational

Funder types: Industry

Identifiers

NCT05021562

Niraparib-4001

jRCT2031210289 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 354 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

An individual who corresponds to any of the following:

• 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

Has a history of hypersensitivity to any of the ingredients of this drug.

Trial design

354 participants in 1 patient group

Niraparib 200-300 milligrams (mg)

Description:

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.

Treatment:

Drug: Niraparib