An observational study to investigate the safety and efficacy of niraparib for Japanese patients with recurrent ovarian cancer: maintenance therapy for platinum-sensitive recurrent treatment and monotherapy for late-line treatment

An observational study to investigate the safety and efficacy of niraparib for Japanese patients with recurrent ovarian cancer: maintenance therapy for platinum-sensitive recurrent treatment and monotherapy for late-line treatment - JGOG3031

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046970

Enrollment

180

Registered

2022-03-15

Start date

2022-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer, fallopian tube cancer, primary peritoneal cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Cohort 1 1.Patients with recurrent ovarian cancer with complete or partial response by the platinum-based combination chemotherapy 2.Patients who started niraparib maintenance therapy after December 2020 3.Japanese female patients aged =>18 years at the time of niraparib administration Cohort 2 1.Patients with homologous recombination deficiency (HRD)-positive tumors sensitive to their last platinum-based chemotherapy who had received there or more anticancer therapy regimens 2.Japanese female patients aged =>18 years at the time of niraparib administration

Exclusion criteria

Exclusion criteria: 1.Patients with active double cancer 2.Patients judged by the investigator to be inappropriate for participation in this study

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	—

Secondary

Measure	Time frame
Progression-free survival (PFS) and PFS rate Response rate in patients with residual disease (ORR) Overall survival (OS) Relationship to subsequent therapy, platinum-free interval Incidence of secondary cancer	—

Countries

Japan

Contacts

Public ContactSatoe Fujiwara

Osaka Medical and Pharmaceutical University Department of Obstetrics and Gynecology

satoe.fujiwara@ompu.ac.jp072-683-1221

Outcome results