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LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04889404
Collaborator
(none)
110
Enrollment
47
Locations
52.3
Anticipated Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    May 22, 2021
    Anticipated Primary Completion Date :
    Sep 30, 2025
    Anticipated Study Completion Date :
    Sep 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events related to the safety specifications [from baseline to 1year]

      Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Osaka Lyn010001 Japan D081FC00004
    2 Research Site Kanagawa Lyn010003 Japan D081FC00004
    3 Research Site Okayama Lyn010004 Japan D081FC00004
    4 Research Site Akita Lyn010005 Japan D081FC00004
    5 Research Site Niigata Lyn010006 Japan D081FC00004
    6 Research Site Shizuoka Lyn010007 Japan D081FC00004
    7 Research Site Niigata Lyn010008 Japan D081FC00004
    8 Research Site Tokyo Lyn010009 Japan D081FC00004
    9 Research Site Saitama Lyn010010 Japan D081FC00004
    10 Research Site Aichi Lyn010011 Japan D081FC00004
    11 Research Site Osaka Lyn010012 Japan D081FC00004
    12 Research Site Tokyo Lyn010013 Japan D081FC00004
    13 Research Site Nara Lyn010014 Japan D081FC00004
    14 Research Site Wakayama Lyn010015 Japan D081FC00004
    15 Research Site Miyagi Lyn010016 Japan D081FC00004
    16 Research Site Tokyo Lyn010017 Japan D081FC00004
    17 Research Site Osaka Lyn010018 Japan D081FC00004
    18 Research Site Gunma Lyn010019 Japan D081FC00004
    19 Research Site Hiroshima Lyn010020 Japan
    20 Research Site Tochigi Lyn010021 Japan D081FC00004
    21 Research Site Iwate Lyn010022 Japan D081FC00004
    22 Research Site Osaka Lyn010025 Japan D081FC00004
    23 Research Site Shizuoka Lyn010026 Japan D081FC00004
    24 Research Site Nagasaki Lyn010027 Japan D081FC00004
    25 Research Site Kumamoto Lyn010028 Japan D081FC00004
    26 Research Site Saitama Lyn010029 Japan D081FC00004
    27 Research Site Nagano Lyn010031 Japan D081FC00004
    28 Research Site Hyogo Lyn010032 Japan D081FC00004
    29 Research Site Shimane Lyn010033 Japan D081FC00004
    30 Research Site Hyogo Lyn010034 Japan D081FC00004
    31 Research Site Shizuoka Lyn010035 Japan D081FC00004
    32 Research Site Hyogo Lyn010036 Japan D081FC00004
    33 Research Site Okayama Lyn010038 Japan D081FC00004
    34 Research Site Hukuoka Lyn010041 Japan
    35 Research Site Hokkaido Lyn010042 Japan
    36 Research Site Ehime Lyn010044 Japan
    37 Research Site Osaka Lyn010045 Japan
    38 Research Site Shizuoka Lyn010047 Japan
    39 Research Site Tokyo Lyn010050 Japan
    40 Research Site Aichi Japan
    41 Research Site Hokkaido Japan
    42 Research Site Hyogo Japan
    43 Research Site Kagawa Japan
    44 Research Site Kyoto Japan
    45 Research Site Nagano Japan
    46 Research Site Nagasaki Japan
    47 Research Site Toyama Japan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Toshimitsu Tokimoto, Astrazeneca KK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04889404
    Other Study ID Numbers:
    • D081FC00004
    First Posted:
    May 17, 2021
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Aug 5, 2022