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NCT00299156 · FLOW

Participant flow

Oral Clofarabine Study in Patients With Myelodysplastic Syndrome · Source last updated 2015-11-03

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

groups
  1. description
    Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    FG000
    title
    Oral Clofarabine
  2. description
    Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    FG001
    title
    Randomized, Oral Clofarabine 10mg
  3. description
    Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    FG002
    title
    Randomized, Oral Clofarabine 20mg
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        32
      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
    Period 1 (Non-Randomized)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Screen Failure
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        16
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 2 (Randomized)
pre Assignment Details
Sixty-five participants were registered, one participant did not receive study treatment. The study consisted of two parts, Phase 1 and a randomized Phase 2 portion.
recruitment Details
Recruitment Period: March 2006 to July 2012. All patients registered at The University of Texas M.D. Anderson Cancer Center.
Complete source fields
groups
  1. description
    Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    FG000
    title
    Oral Clofarabine
  2. description
    Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    FG001
    title
    Randomized, Oral Clofarabine 10mg
  3. description
    Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    FG002
    title
    Randomized, Oral Clofarabine 20mg
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        32
      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
    Period 1 (Non-Randomized)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Screen Failure
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        16
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 2 (Randomized)
pre Assignment Details
Sixty-five participants were registered, one participant did not receive study treatment. The study consisted of two parts, Phase 1 and a randomized Phase 2 portion.
recruitment Details
Recruitment Period: March 2006 to July 2012. All patients registered at The University of Texas M.D. Anderson Cancer Center.

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Preserved source evidence · Not medical advice