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A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
Sponsor: Astellas Pharma Korea, Inc.
Summary
Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer. People in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, the person's doctor will have prescribed PADCEV Injection and other medicines to treat their cancer. People in the study will be treated according to their clinic's standard practice. This study is about collecting information only. This study will survey people who know they are receiving PADCEV Injection. The aims of the study are to check outcomes of treatment with PADCEV and record any medical problems during the study. Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up to 48 weeks (about 1 year) after their first dose. During this time, a person's medical records will be reviewed to check for any medical problems and to follow the condition of their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks, records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV Injection or until they start a different medicine for their cancer.
Official title: Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
202
Start Date
2023-11-01
Completion Date
2027-07-31
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Enfortumab Vedotin
Intravenous
Locations (18)
Site KR82001
Goyang-si, Gyeonggi-do, South Korea
Site KR82012
Suwon, Gyeonggi-do, South Korea
Site KR82008
Suwon, Gyeonggi-do, South Korea
Site KR82007
Jeollanam-do, Jeollanam-do, South Korea
Site KR82013
Jeonju, Jeonbuk-do, South Korea
Site KR82015
Busan, South Korea
Site KR82010
Busan, South Korea
Site KR82009
Busan, South Korea
Site KR82016
Busan, South Korea
Site KR82014
Daegu, South Korea
Site KR82018
Daejeon, South Korea
Site KR82004
Incheon, South Korea
Site KR82002
Seoul, South Korea
Site KR82005
Seoul, South Korea
Site KR82003
Seoul, South Korea
Site KR82017
Seoul, South Korea
Site KR82006
Seoul, South Korea
Site KR82011
Seoul, South Korea