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NCT05835778 Clinical Trial

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

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05835778
Other study ID # D933AC00005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 7, 2023
Est. completion date July 17, 2026

Study information
Verified date March 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 17, 2026
Est. primary completion date July 17, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Aomori
Japan Research Site Chiba
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Fukui
Japan Research Site Fukuoka
Japan Research Site Fukuoka
Japan Research Site Fukuoka
Japan Research Site Fukushima
Japan Research Site Gifu
Japan Research Site Gifu
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hiroshima
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Hyogo
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Iwate
Japan Research Site Kagawa
Japan Research Site Kagoshima
Japan Research Site Kagoshima
Japan Research Site Kanagawa
Japan Research Site Kumamoto
Japan Research Site Kyoto
Japan Research Site Mie
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Nara
Japan Research Site Niigata
Japan Research Site Niigata
Japan Research Site Niigata
Japan Research Site Oita
Japan Research Site Okayama
Japan Research Site Okinawa
Japan Research Site Osaka
Japan Research Site Osaka
Japan Research Site Osaka
Japan Research Site Saga
Japan Research Site Saitama
Japan Research Site Saitama
Japan Research Site Shiga
Japan Research Site Shiga
Japan Research Site Shimane
Japan Research Site Shizuoka
Japan Research Site Tochigi
Japan Research Site Tokyo
Japan Research Site Tokyo
Japan Research Site Tottori
Japan Research Site Wakayama
Japan Research Site Wakayama
Japan Research Site Yamagata
Japan Research Site Yamaguchi
Japan Research Site Yamanashi

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of ADRs 52 weeks
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