Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-05-12
Brief Title:
LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance PMS
Sponsor:
AstraZeneca
Organization:
AstraZeneca
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 specifications1 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:
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