Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03759587 | Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer | PHASE2 | COMPLETED | 19 | — | — | Dec 28, 2018 | Dec 28, 2022 | Jun 7, 2024 | 27 | Japan |
| NCT03759600 | Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer | PHASE2 | COMPLETED | 20 | — | — | Dec 26, 2018 | Dec 28, 2022 | Jul 16, 2024 | 33 | Japan |
An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).
ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST v.1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD.
| Arm | Type | Description |
|---|---|---|
| Niraparib 300 mg | EXPERIMENTAL | Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles). |
| Name | Type | Description |
|---|---|---|
| Niraparib | DRUG | Niraparib capsule |
Inclusion Criteria 1. Japanese female participants aged 20 years or older on the day of signing informed consent. 2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by t...