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

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary endpoints added 7 → 9 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Enrollment increased: 202 → 228 participants
    • Trial sites expanded: 18 → 22 locations
    • Secondary endpoints: 2 to 3
    • Eligibility criteria expanded, about 3 words
  2. Site details revised at 3 of 18 sitesv38
  3. Site details revised at 1 of 18 sitesv37
  4. Site details revised at 3 of 18 sitesv36
  5. Site details revised at 1 of 18 sitesv35
Show 33 earlier versionsHide 33 earlier versions
  1. Site details revised at 2 of 18 sitesv34
  2. 2 versions Re-verified since Feb 2, 2026, no change to tracked fieldsv32-v33
  3. Study sites: 17 to 18v31
  4. Site details revised at 12 of 17 sitesv30
  5. Site details revised at 1 of 17 sitesv29
  6. Re-verified, no change to tracked fieldsv28
  7. Site details revised at 2 of 17 sitesv27
  8. Re-verified, no change to tracked fieldsv26
  9. Site details revised at 1 of 17 sitesv25
  10. Site details revised at 1 of 17 sitesv24
  11. 4 versions Re-verified since Jan 21, 2025, no change to tracked fieldsv20-v23
  12. Site details revised at 17 of 17 sitesv19
  13. Study sites: 16 to 17v18
  14. Re-verified, no change to tracked fieldsv17
  15. Study sites: 15 to 16v16
  16. Study sites: 14 to 15v15
  17. Enrollment target: 235 to 202
    • Study sites: 13 to 14
    v14
  18. Study sites: 12 to 13v13
  19. Re-verified, no change to tracked fieldsv12
  20. Study sites: 11 to 12v11
  21. 4 versions Re-verified since Jan 22, 2024, no change to tracked fieldsv7-v10
  22. Study sites: 9 to 11v6
  23. Start date: Aug 4, 2023 to Nov 1, 2023
    • Study sites: 6 to 9
    v5
  24. Re-verified, no change to tracked fieldsv4
  25. Study sites: 4 to 6v3
  26. Study sites: 1 to 4v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06011954
Lead Sponsor Astellas Pharma Korea, Inc.
Collaborators: Seagen Inc.
Conditions
(from sponsor)		 Urothelial Cancer
Related terms Urinary Bladder Neoplasms
Enrollment 228 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov