Post-Marketing Surveillance (Usage Results Study) of Niraparib in the Treatment of Adult Patients for Approved Indications in South Korea
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Neoplasms
- Sponsor
- Takeda
- Enrollment
- 662
- Locations
- 1
- Primary Endpoint
- Percentage of Participants with AEs, SAEs, and AESIs
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
This is a long-term prospective, observational post-marketing surveillance study of niraparib in participants with ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in complete or partial response to first-line platinum-based chemotherapy or who had complete or partial response to 2 or more lines of platinum-based chemotherapy or who have been treated with 3 or more prior chemotherapy regimens with either: BRCA mutation irrespective of platinum sensitivity; or platinum-sensitive HRD positive. The study will assess the safety and effectiveness of niraparib for its approved indication with real-world setting in South Korea. The study will enroll approximately 600 participants. The data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort: • Participants With Ovarian Cancer The multi-center study will be conducted in South Korea. Data collection will be based on routinely scheduled and emergency visits during a 24-month surveillance period or until end of the study whichever occurs first after drug administration. The overall duration of the study will be approximately 6 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Treated with niraparib outside of the locally approved label in Korea.
- •Niraparib is contraindicated as per product label.
- •Participating in other clinical trials of cancer treatment.
Outcomes
Primary Outcomes
Percentage of Participants with AEs, SAEs, and AESIs
Time Frame: Baseline up to 24 months
Secondary Outcomes
- Time-to-Treatment Discontinuation (TTD)(From the date of first dose administration until discontinuation or death due to any cause whichever occurs first (up to 24 months))
- Progression Free Survival (PFS)(From the date of first dose administration until disease progression or death due to any cause whichever occurs first (up to 24 months))