Survey of Adults in South Korea with Urothelial Cancer Receiving PADCEV Injection
Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea
This study looks at how well PADCEV Injection works and its side effects in adults with advanced urothelial cancer in South Korea over 48 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 202 (estimated) |
| Sex | All |
| Sponsor | Astellas Pharma Inc Industry-sponsored |
| Drugs / interventions | Enfortumab |
| Locations | 18 sites (Goyang-si, Gyeonggi-do and 17 other locations) |
| Trial ID | NCT06011954 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adults in South Korea diagnosed with locally advanced or metastatic urothelial cancer who are receiving PADCEV Injection as part of their standard treatment. The study aims to collect data on treatment outcomes and any medical issues that arise during the observation period, which lasts up to 48 weeks after the first dose of PADCEV. Participants will be monitored through their medical records to assess the effectiveness and safety of the treatment in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults in South Korea with locally advanced or metastatic urothelial cancer who are prescribed PADCEV Injection.
Not a fit: Patients who have contraindications for PADCEV Injection or are receiving investigational medicines during the observation period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of PADCEV Injection for patients with urothelial cancer.
How similar studies have performed: While this study is observational and focuses on a specific treatment, similar studies have shown success in evaluating treatment outcomes for cancer therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who receive treatment with PADCEV Injection, according to the approved local label. Exclusion Criteria: * 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.
Where this trial is running
Goyang-si, Gyeonggi-do and 17 other locations
- Site KR82001 — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
- Site KR82012 — Suwon, Gyeonggi-do, South Korea (Recruiting)
- Site KR82008 — Suwon, Gyeonggi-do, South Korea (Recruiting)
- Site KR82007 — Jeollanam-do, Jeollanam-do, South Korea (Completed)
- Site KR82013 — Jeonju, Jeonbuk-do, South Korea (Recruiting)
- Site KR82015 — Busan, South Korea (Active_not_recruiting)
- Site KR82010 — Busan, South Korea (Recruiting)
- Site KR82009 — Busan, South Korea (Active_not_recruiting)
- Site KR82016 — Busan, South Korea (Recruiting)
- Site KR82014 — Daegu, South Korea (Recruiting)
- Site KR82018 — Daejeon, South Korea (Recruiting)
- Site KR82004 — Incheon, South Korea (Active_not_recruiting)
- Site KR82002 — Seoul, South Korea (Recruiting)
- Site KR82005 — Seoul, South Korea (Recruiting)
- Site KR82003 — Seoul, South Korea (Active_not_recruiting)
- Site KR82017 — Seoul, South Korea (Recruiting)
- Site KR82006 — Seoul, South Korea (Recruiting)
- Site KR82011 — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Astellas Pharma Global Development, Inc.
- Email: astellas.registration@astellas.com
- Phone: 800-888-7704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.