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A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 13 to 15v9
  2. Trial sites expanded: 10 → 13 locationsv8
  3. Study sites: 9 to 10v7
  4. Study sites: 8 to 9v6
  5. Study sites: 7 to 8v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 6 to 7v4
  2. Study sites: 5 to 6v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date changed from estimate of Mar 31, 2025 to Jun 21, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of Mar 31, 2025 to Jun 21, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer. The main aim of the study is to confirm the safety of enfortumab vedotin in Indian adults with urothelial cancer. During the study, people will receive enfortumab vedotin. The study treatment will be given to people slowly through a tube into a vein. This is called an infusion. People will receive 3 separate infusions of enfortumab vedotin in each 28-day (4 weeks) treatment cycle. People visit their study clinic for health-checks several times during and after they receive enfortumab vedotin.
Trial Details
NCT Number NCT06862219
Lead Sponsor Astellas Pharma Global Development, Inc.
Collaborators: Pfizer
Conditions Metastatic Urothelial Carcinoma
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov