Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04889404
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2021-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
LYNPARZA Tablets 100 mg, 150mg General Drug Use-results Study in Patients on Maintenance Treatment After Platinum-based Chemotherapy for BRCA Mutated Curatively Unresectable Pancreas Cancer
Status:
COMPLETED
Status Verified Date:
2025-04
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:
None
Brief Summary:
To collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.
Detailed Description:
To collect and characterise the incidence of adverse events related to the safety specifications\*1 of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.
This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.
\*1: Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity
This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.
\*1: Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: