NCT04589039Completed
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
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 662 (actual)
- First submitted
- 13 Oct 2020
- Start date
- 16 Mar 2020
- Primary completion date
- 11 Sept 2024
- Lead sponsor
- Takeda
- Diseases
- Ovarian cancer
- NCT number
- NCT04589039
What you commit to
- Study type: Observational
- Participants enrolled: 662
- From 16 Mar 2020 to the primary completion date, 11 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treated with niraparib outside of the locally approved label in Korea.
Other illness
- Participating in other clinical trials of cancer treatment.
Other
- Niraparib is contraindicated as per product label.
Who the study is looking for
- 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.
- 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.
- 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.
Age in the registry: 19 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.