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NCT05055050

A Window of Opportunity Phase I Study of UGN-201 in Patients With Bladder Cancer Undergoing Radical Cystectomy Protocol #: 2021-0630

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 5 months later.

See at-risk trials from M.D. Anderson Cancer Center

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Record History

All 16 versions: 8 with changes below, 8 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 31 words
    • Primary and study completion pushed from Aug 31, 2026 to Feb 2, 2027
    • Study description expanded, about 2 words
  2. Trial status: Suspended to Active, Not Recruitingv14
  3. Primary and study completion dates: Aug 31, 2025 to Aug 31, 2026v11
  4. Primary and study completion dates: Aug 31, 2024 to Aug 31, 2025v9
  5. Trial status: Recruiting to Suspended Sponsor's reason: Interim Analysis
    • Site details revised
    v8
Show 2 earlier versionsHide 2 earlier versions
  1. Primary and study completion dates: Aug 31, 2022 to Aug 31, 2024v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 28, 2022 to Jan 24, 2022
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed

Endpoints

Primary

To establish the safety profile of UGN-201 in patients with urothelial carcinoma undergoing radical cystectomy.
Timeframe: through study completion, an average of 1 year

Arms and interventions

UGN-201 Pre Radical CystectomyExperimental

UGN-201 200 mg/50ml

Drugs: UGN-201

Sites

1 site in 1 country

  • M D Anderson Cancer CenterHouston, Texas, United States