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NCT03390504 · FLOW

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A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations · Source last updated 2026-07-06

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

groups
  1. description
    Participants with advanced urothelial cancer and selected fibroblast growth factor receptor (FGFR) aberrations who were previously treated with anti-programmed death-ligand 1 (PD-\[L\]1) agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
    id
    FG000
    title
    Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg
  2. description
    Participants with advanced urothelial cancer and selected FGFR aberrations who were previously treated with PD-(L)1 agent were randomized to receive chemotherapy (vinflunine 320 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion or docetaxel 75 mg/m\^2 IV infusion) on Day 1 of every cycle (each cycle 21 days) until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment or end of treatment. The choice of chemotherapy regimen at each site was determined by the investigator. Participants were then followed up for safety until death, withdrawal of consent, loss of follow up or end of study. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
    id
    FG001
    title
    Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)
  3. description
    Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with anti-PD-(L)1 agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
    id
    FG002
    title
    Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg
  4. description
    Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with PD-(L)1 agent were randomized to receive pembrolizumab 200 mg IV infusion on Day 1 of every cycle (each cycle 21 days) until disease progression, intolerable toxicity, withdrawal of consent, or decision by the investigator to discontinue treatment or end of treatment. Participants were then followed up for safety until death, withdrawal of consent, loss of follow up or end of study. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
    id
    FG003
    title
    Cohort 2: Arm 2B: Pembrolizumab 200 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        6
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        143
      2. group Id
        FG001
        num Subjects
        135
      3. group Id
        FG002
        num Subjects
        175
      4. group Id
        FG003
        num Subjects
        176
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        117
      3. group Id
        FG002
        num Subjects
        173
      4. group Id
        FG003
        num Subjects
        173
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        137
      2. group Id
        FG001
        num Subjects
        114
      3. group Id
        FG002
        num Subjects
        168
      4. group Id
        FG003
        num Subjects
        167
      comment
      Participants who died were considered to have completed the study as per protocol.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
With the implementation of Protocol Amendment 6 (20 January 2023), long term extension (LTE) phase was added in the study.
Complete source fields
groups
  1. description
    Participants with advanced urothelial cancer and selected fibroblast growth factor receptor (FGFR) aberrations who were previously treated with anti-programmed death-ligand 1 (PD-\[L\]1) agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
    id
    FG000
    title
    Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg
  2. description
    Participants with advanced urothelial cancer and selected FGFR aberrations who were previously treated with PD-(L)1 agent were randomized to receive chemotherapy (vinflunine 320 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion or docetaxel 75 mg/m\^2 IV infusion) on Day 1 of every cycle (each cycle 21 days) until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment or end of treatment. The choice of chemotherapy regimen at each site was determined by the investigator. Participants were then followed up for safety until death, withdrawal of consent, loss of follow up or end of study. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
    id
    FG001
    title
    Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)
  3. description
    Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with anti-PD-(L)1 agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
    id
    FG002
    title
    Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg
  4. description
    Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with PD-(L)1 agent were randomized to receive pembrolizumab 200 mg IV infusion on Day 1 of every cycle (each cycle 21 days) until disease progression, intolerable toxicity, withdrawal of consent, or decision by the investigator to discontinue treatment or end of treatment. Participants were then followed up for safety until death, withdrawal of consent, loss of follow up or end of study. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
    id
    FG003
    title
    Cohort 2: Arm 2B: Pembrolizumab 200 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        6
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        143
      2. group Id
        FG001
        num Subjects
        135
      3. group Id
        FG002
        num Subjects
        175
      4. group Id
        FG003
        num Subjects
        176
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        117
      3. group Id
        FG002
        num Subjects
        173
      4. group Id
        FG003
        num Subjects
        173
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        137
      2. group Id
        FG001
        num Subjects
        114
      3. group Id
        FG002
        num Subjects
        168
      4. group Id
        FG003
        num Subjects
        167
      comment
      Participants who died were considered to have completed the study as per protocol.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
With the implementation of Protocol Amendment 6 (20 January 2023), long term extension (LTE) phase was added in the study.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice