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Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv12
  2. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 53 to confirmed 21
    • Primary completion date changed from estimate of Jul 2020 to Jul 12, 2020
    v11
  3. Trial status: Recruiting to Suspended Sponsor's reason: Pending Interim Analysis
    • Site details revised at 3 of 3 sites
    v10
  4. Study sites: 1 to 3v9
  5. Collaborators expanded, about 8 wordsv8
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  1. Study title expanded, about 3 wordsv7
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2018 to Nov 27, 2017
    • Eligibility criteria shortened, about 16 words
    • Study title expanded, about 1 word
  4. Start date: Nov 1, 2017 to Feb 1, 2018v4
  5. Start date: Sep 2017 to Nov 1, 2017v3
  6. Start date: Aug 2017 to Sep 2017v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a single arm Phase II study with a safety run-in to identify the recommended phase II dose of the combination therapy of atezolizumab and guadecitabine. Patients with recurrent/advanced urothelial carcinoma (stage IV) who had previously progressed on check-point inhibitor therapy with PD-1 or PD-L1 targeting agents are eligible for this study. After a dose that is safe and tolerable has been established, a dose expansion phase (Phase II) will begin. This study will enroll a total of 4 to 53 patients depending upon the number of patients treated in the safety run-in phase and the number of subjects replaced during the phase II portion.
Trial Details
NCT Number NCT03179943
Lead Sponsor Fox Chase Cancer Center
Collaborators: Stand Up To Cancer, Van Andel Research Institute
Conditions
(from sponsor)		 Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell, Ureteral Neoplasms, Urethral Neoplasms, Urinary Bladder Neoplasms
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov