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NCT00629343 · FLOW

Participant flow

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide · Source last updated 2025-06-05

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

groups
  1. description
    Cohort 1: Participants received 25 mg Azacitidine sub-cutaneously, and 200 mg/m2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
    id
    FG000
    title
    Azacitidine 25mg
  2. description
    Cohort 2: Participants received 50 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
    id
    FG001
    title
    Azacitidine 50 mg
  3. description
    Cohort 3: Participants received 75 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
    id
    FG002
    title
    Azacitidine 75 mg
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      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
    Dose Level 1: Azacitidine 25mg
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      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
    Dose Level 2: Azacitidine 50 mg
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      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
    Dose Level 3: Azacitidine 75mg
pre Assignment Details
27 participants signed a consent form and four were determined to be ineligible, resulting in 23 assigned to treatment.
Complete source fields
groups
  1. description
    Cohort 1: Participants received 25 mg Azacitidine sub-cutaneously, and 200 mg/m2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
    id
    FG000
    title
    Azacitidine 25mg
  2. description
    Cohort 2: Participants received 50 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
    id
    FG001
    title
    Azacitidine 50 mg
  3. description
    Cohort 3: Participants received 75 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
    id
    FG002
    title
    Azacitidine 75 mg
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      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
    Dose Level 1: Azacitidine 25mg
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      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
    Dose Level 2: Azacitidine 50 mg
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      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
    Dose Level 3: Azacitidine 75mg
pre Assignment Details
27 participants signed a consent form and four were determined to be ineligible, resulting in 23 assigned to treatment.

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Preserved source evidence · Not medical advice