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NCT04889404 Clinical Trial

LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04889404
Other study ID # D081FC00004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 22, 2021
Est. completion date September 30, 2025

Study information
Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who receive LYNPARZA for the first time for the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated curatively unresectable pancreas cancer after the approval date of partial change application for the additional indication (25/Dec./2020). Exclusion Criteria: - Patients who have no treatment history with LYNPARZA

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi Lyn010011
Japan Research Site Aichi
Japan Research Site Akita Lyn010005
Japan Research Site Chiba
Japan Research Site Ehime Lyn010044
Japan Research Site Fukuoka
Japan Research Site Fukuoka Lyn010041
Japan Research Site Gunma
Japan Research Site Gunma Lyn010019
Japan Research Site Hiroshima Lyn010020
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hokkaido Lyn010042
Japan Research Site Hyogo
Japan Research Site Hyogo
Japan Research Site Hyogo Lyn010034
Japan Research Site Hyogo Lyn010036
Japan Research Site Hyogo Lyn010032
Japan Research Site Ibaraki
Japan Research Site Iwate Lyn010022
Japan Research Site Kagawa
Japan Research Site Kanagawa
Japan Research Site Kanagawa Lyn010003
Japan Research Site Kumamoto Lyn010028
Japan Research Site Kyoto
Japan Research Site Kyoto
Japan Research Site Miyagi Lyn010016
Japan Research Site Nagano
Japan Research Site Nagano
Japan Research Site Nagano Lyn010031
Japan Research Site Nagasaki
Japan Research Site Nagasaki Lyn010027
Japan Research Site Nara Lyn010014
Japan Research Site Nara
Japan Research Site Niigata Lyn010006
Japan Research Site Niigata Lyn010008
Japan Research Site Okayama Lyn010004
Japan Research Site Okayama Lyn010038
Japan Research Site Okayama
Japan Research Site Osaka
Japan Research Site Osaka Lyn010045
Japan Research Site Osaka Lyn010018
Japan Research Site Osaka Lyn010025
Japan Research Site Osaka Lyn010001
Japan Research Site Osaka Lyn010012
Japan Research Site Saitama Lyn010010
Japan Research Site Saitama Lyn010029
Japan Research Site Shimane Lyn010033
Japan Research Site Shizuoka Lyn010026
Japan Research Site Shizuoka Lyn010047
Japan Research Site Shizuoka Lyn010035
Japan Research Site Shizuoka Lyn010007
Japan Research Site Shizuoka
Japan Research Site Tochigi Lyn010021
Japan Research Site Tokyo Lyn010017
Japan Research Site Tokyo Lyn010013
Japan Research Site Tokyo Lyn010009
Japan Research Site Tokyo Lyn010050
Japan Research Site Tokyo
Japan Research Site Tottori
Japan Research Site Toyama
Japan Research Site Wakayama Lyn010015
Japan Research Site Yamagata

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events related to the safety specifications Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity from baseline to 1year
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