Trial Title:
Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI
NCT ID:
NCT05835778
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
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).
Criteria for eligibility:
Study pop:
Patients with curatively unresectable biliary tract cancer
Sampling method:
Non-Probability Sample
Criteria:
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:
-
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Aichi
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Aichi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Akita
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Aomori
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ehime
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fukui
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Fukushima
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gifu
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Gifu
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gunma
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hokkaido
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hokkaido
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ibaraki
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Iwate
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kagawa
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kagoshima
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kagoshima
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kanagawa
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kumamoto
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kyoto
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mie
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mie
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Miyagi
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Nagano
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagasaki
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nara
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Niigata
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Niigata
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Niigata
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Oita
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Okayama
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Okinawa
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saga
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Saitama
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saitama
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shiga
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shiga
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shimane
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shizuoka
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tochigi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tottori
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Wakayama
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Wakayama
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Yamagata
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Yamaguchi
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Yamanashi
Country:
Japan
Status:
Active, not recruiting
Start date:
June 7, 2023
Completion date:
July 17, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05835778
