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NCT03814005 · FLOW

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A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems · Source last updated 2024-09-05

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

groups
  1. description
    Pevonedistat 20 mg/m\^2, infusion, intravenously (IV), once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously (SC) in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
    id
    FG000
    title
    Control Arm
  2. description
    Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 15 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
    id
    FG001
    title
    Renal Arm
  3. description
    Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
    id
    FG002
    title
    Mild Hepatic Arm
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      comment
      Response-evaluable population included participants who received at least 1 dose of study drug, had a baseline disease assessment, and had at least 1 postbaseline disease assessment to analyze response.
      type
      Response-evaluable Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part A: Day 1 to Day 4
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Washout Period : Day 4 to Day 7
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Unsatisfactory Therapeutic Response
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Symptomatic Deterioration
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Part B: Day 8 to Day 343
pre Assignment Details
Participants with myelodysplastic syndromes (MDS), and acute myelogenous leukemia (AML) who also had severe renal impairment or mild hepatic impairment were enrolled in this study to receive single dose of pevonedistat in Part A followed by a wash out period and pevonedistat in combination with standard of care agent in Part B. No participants with chronic myelomonocytic leukemia (CMML) and solid tumors were enrolled in this study.
recruitment Details
Participants took part in the study at 5 investigative sites in United States and Spain from 10 July 2019 to 19 April 2022.
Complete source fields
groups
  1. description
    Pevonedistat 20 mg/m\^2, infusion, intravenously (IV), once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously (SC) in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
    id
    FG000
    title
    Control Arm
  2. description
    Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 15 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
    id
    FG001
    title
    Renal Arm
  3. description
    Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
    id
    FG002
    title
    Mild Hepatic Arm
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      comment
      Response-evaluable population included participants who received at least 1 dose of study drug, had a baseline disease assessment, and had at least 1 postbaseline disease assessment to analyze response.
      type
      Response-evaluable Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part A: Day 1 to Day 4
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Washout Period : Day 4 to Day 7
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Unsatisfactory Therapeutic Response
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Symptomatic Deterioration
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Part B: Day 8 to Day 343
pre Assignment Details
Participants with myelodysplastic syndromes (MDS), and acute myelogenous leukemia (AML) who also had severe renal impairment or mild hepatic impairment were enrolled in this study to receive single dose of pevonedistat in Part A followed by a wash out period and pevonedistat in combination with standard of care agent in Part B. No participants with chronic myelomonocytic leukemia (CMML) and solid tumors were enrolled in this study.
recruitment Details
Participants took part in the study at 5 investigative sites in United States and Spain from 10 July 2019 to 19 April 2022.

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Preserved source evidence · Not medical advice