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

Inclusion Criteria1

  • Patients who receive treatment with PADCEV Injection, according to the approved local label.

Exclusion Criteria2

  • Patients with any contraindication for PADCEV Injection, according to the approved local label.
  • Patients who receive or are going to receive any investigational medicine during the observation period.

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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