Clinical trial · Observational
A Study for Post-Marketing Surveillance of Niraparib in the Treatment of Adult Participants for Approved Indications in South Korea
Post-Marketing Surveillance (Usage Results Study) of Niraparib in the Treatment of Adult Patients for Approved Indications in South Korea
NCT04589039CI-TRIAL-00083586completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to estimate the cumulative incidence of all adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESI), among participants who have been administered niraparib as per the approved indications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Participants with Ovarian Cancer
- description
- Participants diagnosed with ovarian cancer (including fallopian tube or primary peritoneal cancer) who have been prescribed with niraparib for the first time in a real-world setting, and who are in a complete or partial response to first-line platinum-based chemotherapy or who had complete or partial response to 2 or more line of platinum-based chemotherapy or who have been treated with 3 or more prior chemotherapy regimens with either breast cancer susceptibility gene (BRCA) mutation (irrespective of platinum sensitivity) or platinum-sensitive homologous recombination deficiency (HRD) positive will be observed prospectively over 24-month period, or until treatment discontinuation, or until end of study, which occurs first.
Primary outcomes (1)
- measure
- Percentage of Participants with AEs, SAEs, and AESIs
- timeFrame
- Baseline up to 24 months
Secondary outcomes (2)
- measure
- Time-to-Treatment Discontinuation (TTD)
- timeFrame
- From the date of first dose administration until discontinuation or death due to any cause whichever occurs first (up to 24 months)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Monotherapy for the maintenance treatment of adult participants with ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. 2. Monotherapy for the maintenance treatment of adult participants with recurrent high-grade serous ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in a complete or partial response to 2 or more lines of platinum-based chemotherapy. 3. Monotherapy treatment of adult participants with recurrent ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens with either a) BRCA mutation (irrespective of platinum sensitivity) or b) platinum-sensitive HRD positive. Exclusion Criteria: 1. Treated with niraparib outside of the locally approved label in Korea. 2. Niraparib is contraindicated as per product label. 3. Participating in other clinical trials of cancer treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.