RecruitingNCT06011954

A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea


Sponsor

Astellas Pharma Korea, Inc.

Enrollment

202 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This is a post-marketing observational survey in South Korea studying adults with cancer who are receiving a drug called PADCEV (enfortumab vedotin), typically used for bladder cancer. Researchers are collecting real-world safety and effectiveness information. **You may be eligible if...** - You are an adult with cancer in South Korea - You are currently receiving PADCEV injection according to its approved local prescribing guidelines **You may NOT be eligible if...** - You have a known contraindication to PADCEV per its approved guidelines - You are receiving or planning to receive any other investigational (experimental) drug during the observation period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnfortumab 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

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NCT06011954


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