Clinical trial NCT04889404: LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on maintenance treatment after platinum-based chemotherapy for BRCA mutated curatively unresectable pancreas cancer

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events related to the safety specifications
timeFrame: from baseline to 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Research Site
state: Lyn010001
city: Kanagawa
country: Japan
facility: Research Site
state: Lyn010003
city: Okayama
country: Japan
facility: Research Site
state: Lyn010004
city: Akita
country: Japan
facility: Research Site
state: Lyn010005
city: Niigata
country: Japan
facility: Research Site
state: Lyn010006
city: Shizuoka
country: Japan
facility: Research Site
state: Lyn010007
city: Niigata
country: Japan
facility: Research Site
state: Lyn010008
city: Tokyo
country: Japan
facility: Research Site
state: Lyn010009
city: Saitama
country: Japan
facility: Research Site
state: Lyn010010
city: Aichi
country: Japan
facility: Research Site
state: Lyn010011
city: Osaka
country: Japan
facility: Research Site
state: Lyn010012
city: Tokyo
country: Japan
facility: Research Site
state: Lyn010013
city: Nara
country: Japan
facility: Research Site
state: Lyn010014
city: Wakayama
country: Japan
facility: Research Site
state: Lyn010015
city: Miyagi
country: Japan
facility: Research Site
state: Lyn010016
city: Tokyo
country: Japan
facility: Research Site
state: Lyn010017
city: Osaka
country: Japan
facility: Research Site
state: Lyn010018
city: Gunma
country: Japan
facility: Research Site
state: Lyn010019
city: Hiroshima
country: Japan
facility: Research Site
state: Lyn010020
city: Tochigi
country: Japan
facility: Research Site
state: Lyn010021
city: Iwate
country: Japan
facility: Research Site
state: Lyn010022
city: Osaka
country: Japan
facility: Research Site
state: Lyn010025
city: Shizuoka
country: Japan
facility: Research Site
state: Lyn010026
city: Nagasaki
country: Japan
facility: Research Site
state: Lyn010027
city: Kumamoto
country: Japan
facility: Research Site
state: Lyn010028
city: Saitama
country: Japan
facility: Research Site
state: Lyn010029
city: Nagano
country: Japan
facility: Research Site
state: Lyn010031
city: Hyogo
country: Japan
facility: Research Site
state: Lyn010032
city: Shimane
country: Japan
facility: Research Site
state: Lyn010033
city: Hyogo
country: Japan
facility: Research Site
state: Lyn010034
city: Shizuoka
country: Japan
facility: Research Site
state: Lyn010035
city: Hyogo
country: Japan
facility: Research Site
state: Lyn010036
city: Okayama
country: Japan
facility: Research Site
state: Lyn010038
city: Fukuoka
country: Japan
facility: Research Site
state: Lyn010041
city: Hokkaido
country: Japan
facility: Research Site
state: Lyn010042
city: Ehime
country: Japan
facility: Research Site
state: Lyn010044
city: Osaka
country: Japan
facility: Research Site
state: Lyn010045
city: Shizuoka
country: Japan
facility: Research Site
state: Lyn010047
city: Tokyo
country: Japan
facility: Research Site
state: Lyn010050
city: Aichi
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
affiliation: Astrazeneca KK
name: Toshimitsu Tokimoto
role: STUDY_DIRECTOR
References: