LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

Study Overview

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.

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

Pancreatic Neoplasms

D081FC00004

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-05-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-14
First Submitted that Met QC Criteria 2021-05-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-15
First Posted (ACTUAL) 2021-05-17	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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).

Patients who have no treatment history with LYNPARZA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Toshimitsu Tokimoto, Astrazeneca KK

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record