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Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI

Sponsor
AstraZeneca (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05835778
Collaborator
(none)
200
Enrollment
29.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive IMFINZI in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing setting.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This investigation will be conducted to investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive IMFINZI Intravenous Infusion 120mg, 500mg in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing setting.

    The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

    Among the safety specifications defined in the Japan Risk Management Plan of IMFINZI, the following items are set as the safety specifications for this study.

    Interstitial lung disease, Colitis/Severe diarrhoea, Hepatic function disorder/Hepatis/Cholangitis Sclerosing, Endocrine disorders (Dysfunction thyroid, Dysfunction adrenal, Pituitary dysfunction), Type 1 diabetes mellitus, Renal disorder (interstitial nephritis, etc), Myositis, Myocarditis, Myasthenia gravis, Immune thrombocytopenic purpura, Encephalitis, Severe skin disorder, Nerve disorder (including guillain-barre syndrome), Infusion reaction, Pancreatitis, Gastrointestinal perforation, Rhabdomyolysis, Meningitis, Febrile neutropenia during combination treatment with chemotherapy, Embryo-fetal toxicity and Use in patients with a history of organ transplant (including haematopoietic stem cell transplant).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Specific Use-results Study of IMFINZI Intravenous Infusion 120 mg,500mg in Patients With Curatively Unresectable Biliary Tract Cancer
    Anticipated Study Start Date :
    May 31, 2023
    Anticipated Primary Completion Date :
    Nov 16, 2025
    Anticipated Study Completion Date :
    Nov 16, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of ADRs [52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with curatively unresectable biliary tract cancer who receive IMFINZI for the first time in combination with gemcitabine hydrochloride and cisplatin.
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT05835778
    Other Study ID Numbers:
    • D933AC00005
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:
    Biliary Tract Neoplasms

    Study Results

    No Results Posted as of Apr 28, 2023