LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

April 8, 2024 updated by: AstraZeneca

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

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

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

Study Contact

Study Locations

  • Japan
      • Aichi, Japan
        • Recruiting
        • Research Site
      • Chiba, Japan
        • Recruiting
        • Research Site
      • Fukuoka, Japan
        • Recruiting
        • Research Site
      • Gunma, Japan
        • Recruiting
        • Research Site
      • Hiroshima, Japan
        • Recruiting
        • Research Site
      • Hokkaido, Japan
        • Recruiting
        • Research Site
      • Hyogo, Japan
        • Recruiting
        • Research Site
      • Hyogo, Japan
        • Completed
        • Research Site
      • Ibaraki, Japan
        • Recruiting
        • Research Site
      • Kagawa, Japan
        • Recruiting
        • Research Site
      • Kanagawa, Japan
        • Recruiting
        • Research Site
      • Kyoto, Japan
        • Recruiting
        • Research Site
      • Kyoto, Japan
        • Completed
        • Research Site
      • Nagano, Japan
        • Recruiting
        • Research Site
      • Nagano, Japan
        • Completed
        • Research Site
      • Nagasaki, Japan
        • Recruiting
        • Research Site
      • Nara, Japan
        • Recruiting
        • Research Site
      • Okayama, Japan
        • Recruiting
        • Research Site
      • Osaka, Japan
        • Recruiting
        • Research Site
      • Shizuoka, Japan
        • Recruiting
        • Research Site
      • Tokyo, Japan
        • Recruiting
        • Research Site
      • Tottori, Japan
        • Recruiting
        • Research Site
      • Toyama, Japan
        • Recruiting
        • Research Site
      • Yamagata, Japan
        • Recruiting
        • Research Site
    • Lyn010001
      • Osaka, Lyn010001, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010003
      • Kanagawa, Lyn010003, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010004
      • Okayama, Lyn010004, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010005
      • Akita, Lyn010005, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010006
      • Niigata, Lyn010006, Japan, D081FC00004
        • Completed
        • Research Site
    • Lyn010007
      • Shizuoka, Lyn010007, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010008
      • Niigata, Lyn010008, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010009
      • Tokyo, Lyn010009, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010010
      • Saitama, Lyn010010, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010011
      • Aichi, Lyn010011, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010012
      • Osaka, Lyn010012, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010013
      • Tokyo, Lyn010013, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010014
      • Nara, Lyn010014, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010015
      • Wakayama, Lyn010015, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010016
      • Miyagi, Lyn010016, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010017
      • Tokyo, Lyn010017, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010018
      • Osaka, Lyn010018, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010019
      • Gunma, Lyn010019, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010020
      • Hiroshima, Lyn010020, Japan
        • Recruiting
        • Research Site
    • Lyn010021
      • Tochigi, Lyn010021, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010022
      • Iwate, Lyn010022, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010025
      • Osaka, Lyn010025, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010026
      • Shizuoka, Lyn010026, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010027
      • Nagasaki, Lyn010027, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010028
      • Kumamoto, Lyn010028, Japan, D081FC00004
        • Completed
        • Research Site
    • Lyn010029
      • Saitama, Lyn010029, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010031
      • Nagano, Lyn010031, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010032
      • Hyogo, Lyn010032, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010033
      • Shimane, Lyn010033, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010034
      • Hyogo, Lyn010034, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010035
      • Shizuoka, Lyn010035, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010036
      • Hyogo, Lyn010036, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010038
      • Okayama, Lyn010038, Japan, D081FC00004
        • Recruiting
        • Research Site
    • Lyn010041
      • Fukuoka, Lyn010041, Japan
        • Recruiting
        • Research Site
    • Lyn010042
      • Hokkaido, Lyn010042, Japan
        • Recruiting
        • Research Site
    • Lyn010044
      • Ehime, Lyn010044, Japan
        • Recruiting
        • Research Site
    • Lyn010045
      • Osaka, Lyn010045, Japan
        • Recruiting
        • Research Site
    • Lyn010047
      • Shizuoka, Lyn010047, Japan
        • Recruiting
        • Research Site
    • Lyn010050
      • Tokyo, Lyn010050, Japan
        • Recruiting
        • Research Site

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients on maintenance treatment after platinum-based chemotherapy for BRCA mutated curatively unresectable pancreas cancer

Description

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 Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Toshimitsu Tokimoto, AstraZeneca KK

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 Major Dates

Study Start (Actual)

May 22, 2021

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D081FC00004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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