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

February 13, 2024 updated by: AstraZeneca

Specific Use-results Study of IMFINZI Intravenous Infusion 120 mg,500mg in Patients With Curatively Unresectable Biliary Tract Cancer

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.

Study Overview

Status

Recruiting

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 Type

Observational

Enrollment (Estimated)

200

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

      • Aichi, Japan
        • Active, not recruiting
        • Research Site
      • Aichi, Japan
        • Recruiting
        • Research Site
      • Akita, Japan
        • Active, not recruiting
        • Research Site
      • Aomori, Japan
        • Recruiting
        • Research Site
      • Chiba, Japan
        • Recruiting
        • Research Site
      • Chiba, Japan
        • Not yet recruiting
        • Research Site
      • Ehime, Japan
        • Active, not recruiting
        • Research Site
      • Fukui, Japan
        • Recruiting
        • Research Site
      • Fukuoka, Japan
        • Active, not recruiting
        • Research Site
      • Fukuoka, Japan
        • Recruiting
        • Research Site
      • Fukuoka, Japan
        • Withdrawn
        • Research Site
      • Fukushima, Japan
        • Recruiting
        • Research Site
      • Gifu, Japan
        • Active, not recruiting
        • Research Site
      • Gifu, Japan
        • Not yet recruiting
        • Research Site
      • Gunma, Japan
        • Recruiting
        • Research Site
      • Hiroshima, Japan
        • Recruiting
        • Research Site
      • Hiroshima, Japan
        • Withdrawn
        • Research Site
      • Hokkaido, Japan
        • Recruiting
        • Research Site
      • Hokkaido, Japan
        • Active, not recruiting
        • Research Site
      • Hyogo, Japan
        • Active, not recruiting
        • Research Site
      • Hyogo, Japan
        • Recruiting
        • Research Site
      • Hyogo, Japan
        • Not yet recruiting
        • Research Site
      • Ibaraki, Japan
        • Active, not recruiting
        • Research Site
      • Iwate, Japan
        • Recruiting
        • Research Site
      • Kagawa, Japan
        • Recruiting
        • Research Site
      • Kagoshima, Japan
        • Recruiting
        • Research Site
      • Kagoshima, Japan
        • Active, not recruiting
        • Research Site
      • Kanagawa, Japan
        • Recruiting
        • Research Site
      • Kumamoto, Japan
        • Active, not recruiting
        • Research Site
      • Kyoto, Japan
        • Recruiting
        • Research Site
      • Mie, Japan
        • Active, not recruiting
        • Research Site
      • Mie, Japan
        • Recruiting
        • Research Site
      • Miyagi, Japan
        • Active, not recruiting
        • Research Site
      • Miyagi, Japan
        • Recruiting
        • Research Site
      • Nagano, Japan
        • Recruiting
        • Research Site
      • Nagasaki, Japan
        • Recruiting
        • Research Site
      • Nara, Japan
        • Not yet recruiting
        • Research Site
      • Niigata, Japan
        • Recruiting
        • Research Site
      • Niigata, Japan
        • Active, not recruiting
        • Research Site
      • Niigata, Japan
        • Withdrawn
        • Research Site
      • Oita, Japan
        • Active, not recruiting
        • Research Site
      • Okayama, Japan
        • Recruiting
        • Research Site
      • Okinawa, Japan
        • Active, not recruiting
        • Research Site
      • Osaka, Japan
        • Active, not recruiting
        • Research Site
      • Osaka, Japan
        • Recruiting
        • Research Site
      • Osaka, Japan
        • Withdrawn
        • Research Site
      • Saga, Japan
        • Withdrawn
        • Research Site
      • Saitama, Japan
        • Recruiting
        • Research Site
      • Saitama, Japan
        • Not yet recruiting
        • Research Site
      • Shiga, Japan
        • Recruiting
        • Research Site
      • Shiga, Japan
        • Not yet recruiting
        • Research Site
      • Shimane, Japan
        • Recruiting
        • Research Site
      • Shizuoka, Japan
        • Recruiting
        • Research Site
      • Tochigi, Japan
        • Recruiting
        • Research Site
      • Tokyo, Japan
        • Recruiting
        • Research Site
      • Tokyo, Japan
        • Active, not recruiting
        • Research Site
      • Tokyo, Japan
        • Not yet recruiting
        • Research Site
      • Tottori, Japan
        • Active, not recruiting
        • Research Site
      • Wakayama, Japan
        • Active, not recruiting
        • Research Site
      • Wakayama, Japan
        • Withdrawn
        • Research Site
      • Yamagata, Japan
        • Recruiting
        • Research Site
      • Yamaguchi, Japan
        • Recruiting
        • Research Site
      • Yamanashi, Japan
        • Active, not 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 with curatively unresectable biliary tract cancer

Description

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:

-

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of ADRs
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

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

Sponsor

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)

June 7, 2023

Primary Completion (Estimated)

November 16, 2025

Study Completion (Estimated)

November 16, 2025

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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