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NCT02323880 · FLOW

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Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas · Source last updated 2025-01-14

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

groups
  1. description
    35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
    id
    FG000
    title
    Part A: Dose Level 1
  2. description
    35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
    id
    FG001
    title
    Part A: Dose Level 1 (DL 1)
  3. description
    20 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
    id
    FG002
    title
    Part A: Dose Level -1 (DL -1)
  4. description
    45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    FG003
    title
    Part A: Weekly Dose Level 1 (WDL 1)
  5. description
    35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    FG004
    title
    Part A: Weekly Dose Level -1 (WDL -1)
  6. description
    35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    FG005
    title
    Part B: Weekly Dose Level -1 (WDL -1)
  7. description
    20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
    id
    FG006
    title
    Part PK: Dose Level -1 (DL -1)
  8. description
    35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    FG007
    title
    Part PK: Weekly Dose Level -1 (WDL -1)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        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
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        6
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        6
      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
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
    id
    FG000
    title
    Part A: Dose Level 1
  2. description
    35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
    id
    FG001
    title
    Part A: Dose Level 1 (DL 1)
  3. description
    20 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
    id
    FG002
    title
    Part A: Dose Level -1 (DL -1)
  4. description
    45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    FG003
    title
    Part A: Weekly Dose Level 1 (WDL 1)
  5. description
    35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    FG004
    title
    Part A: Weekly Dose Level -1 (WDL -1)
  6. description
    35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    FG005
    title
    Part B: Weekly Dose Level -1 (WDL -1)
  7. description
    20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
    id
    FG006
    title
    Part PK: Dose Level -1 (DL -1)
  8. description
    35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    FG007
    title
    Part PK: Weekly Dose Level -1 (WDL -1)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        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
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        6
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        6
      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
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice