'OLAP' (OLAparib Regulatory Post-marketing Surveillance)
OLAP
Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance
1 other identifier
observational
661
1 country
18
Brief Summary
The objectives of this study are to assess safety and effectiveness of Lynparza tablet (olaparib, hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug according to the approved indications in South Korea
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2020
CompletedFirst Posted
Study publicly available on registry
September 18, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2025
CompletedAugust 14, 2025
August 1, 2025
4.4 years
September 10, 2020
August 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
For about 1 year since the first dose of the study drug
Secondary Outcomes (1)
6-month real-world Progression free survival (rwPFS)
For about 1 year since the first dose of the study drug
Other Outcomes (1)
1-year real-world Progression free survival (rwPFS)
For about 18 months since the first dose of the study drug
Eligibility Criteria
On active study drug treatment according to the approved local label.
You may qualify if:
- Eligible for the study drug treatment according to the approved label in South Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
You may not qualify if:
- History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
- Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug
- Pregnant and/or breast feeding
- Current participation in any interventional trial
- Other off-label indications according to the approved label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Ansan, South Korea
Research Site
Bucheon-si, South Korea
Research Site
Busan, South Korea
Research Site
Changwon, South Korea
Research Site
Daegu, South Korea
Research Site
Daejeon, South Korea
Research Site
Goyang, South Korea
Research Site
Gunpo, South Korea
Research Site
Hwaseong, South Korea
Research Site
Ilsan, South Korea
Research Site
Incheon, South Korea
Research Site
Jeonju, South Korea
Research Site
Seongnam, South Korea
Research Site
Seoul, South Korea
Research Site
Suwon, South Korea
Research Site
Uijeongbu-si, South Korea
Research Site
Yangsan, South Korea
Research Site
Yŏngin, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2020
First Posted
September 18, 2020
Study Start
February 1, 2021
Primary Completion
July 11, 2025
Study Completion
July 11, 2025
Last Updated
August 14, 2025
Record last verified: 2025-08