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NCT00738582 · FLOW

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An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma · Source last updated 2022-09-22

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

groups
  1. description
    Participants received amatuximab 5 milligram per kilogram (mg/kg), Intravenous (IV) infusion on Days 1 and 8 with pemetrexed 500 milligram per meter square (mg/m\^2), IV infusion on Day 1 and cisplatin 75 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).
    id
    FG000
    title
    Amatuximab/Pemetrexed/Cisplatin
  2. description
    Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles) (Cycle length is 21 days).
    id
    FG001
    title
    Amatuximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Completed Combination Therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Toxicity to Chemotherapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      type
      Progressive Disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        89
      2. group Id
        FG001
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Combination Therapy
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        47
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        This arm ended once all participants entered into the Maintenance Therapy phase of the study.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Only eligible participants entered into this phase of the study.
        group Id
        FG001
        num Subjects
        56
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        56
      type
      NOT COMPLETED
    title
    Maintenance Therapy
Complete source fields
groups
  1. description
    Participants received amatuximab 5 milligram per kilogram (mg/kg), Intravenous (IV) infusion on Days 1 and 8 with pemetrexed 500 milligram per meter square (mg/m\^2), IV infusion on Day 1 and cisplatin 75 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).
    id
    FG000
    title
    Amatuximab/Pemetrexed/Cisplatin
  2. description
    Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles) (Cycle length is 21 days).
    id
    FG001
    title
    Amatuximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Completed Combination Therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Toxicity to Chemotherapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      type
      Progressive Disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        89
      2. group Id
        FG001
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Combination Therapy
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        47
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        This arm ended once all participants entered into the Maintenance Therapy phase of the study.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Only eligible participants entered into this phase of the study.
        group Id
        FG001
        num Subjects
        56
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        56
      type
      NOT COMPLETED
    title
    Maintenance Therapy

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Preserved source evidence · Not medical advice