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NCT04602078 · FLOW

Participant flow

Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma · Source last updated 2025-04-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
    id
    FG000
    title
    AUREA Single-arm
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        66
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Patients screened
Complete source fields
groups
  1. description
    Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
    id
    FG000
    title
    AUREA Single-arm
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        66
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Patients screened

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Preserved source evidence · Not medical advice