Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04553926
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2020-09-10
Brief Title:
OLAP OLAparib Regulatory Post-marketing Surveillance
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Lynparza Tablet Olaparib Regulatory Post-Marketing Surveillance
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OLAP
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
Detailed Description:
Primary Objective To assess the safety of the study drug for patients prescribed with the study drug under the approved indications in South Korea Secondary Objective To assess effectiveness of the study drug for patients prescribed with the study drug under the approved indication in South Korea Exploratory Objective To assess effectiveness of the study drug for ovarian cancer patients diagnosed as Homologous Recombination Deficiency HRD positive via locally available validated HRD test and prescribed with the study drug under the approved indication in South Korea
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None