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NCT02717455 · FLOW

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Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma · Source last updated 2024-04-25

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

groups
  1. description
    Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 10 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Stratum 1, Dose Level 1 (10 mg/m^2)
  2. description
    Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Stratum 1, Dose Level 2 (16 mg/m^2)
  3. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG002
    title
    Stratum 2, Dose Level 1 (16 mg/m^2)
  4. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 22 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG003
    title
    Stratum 2, Dose Level 2 (22 mg/m^2)
  5. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 28 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG004
    title
    Stratum 2, Dose Level 3 (28 mg/m^2)
  6. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 36 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG005
    title
    Stratum 2, Dose Level 4 (36 mg/m^2)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      type
      Death
    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
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Did not receive study drug
    5. 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
      type
      Extended delay in start of next cycle for reasons unrelated to treatment
    6. 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
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Patient off-treatment for other complicating disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        12
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients with recurrent/progressive diffuse intrinsic pontine glioma (DIPG) were enrolled on stratum 1, and patients with non-progressed DIPG or H3K27M+ thalamic diffuse malignant glioma (DMG) were enrolled on stratum 2.
recruitment Details
Patients between 2 and 22 years of age (\>= 2, \< 22) at the time of enrollment were enrolled at Pediatric Brain Tumor Consortium (PBTC) member institutions. The first patient on study was enrolled on June 28, 2016, and the last patient was enrolled on November 10, 2021.
Complete source fields
groups
  1. description
    Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 10 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Stratum 1, Dose Level 1 (10 mg/m^2)
  2. description
    Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Stratum 1, Dose Level 2 (16 mg/m^2)
  3. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG002
    title
    Stratum 2, Dose Level 1 (16 mg/m^2)
  4. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 22 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG003
    title
    Stratum 2, Dose Level 2 (22 mg/m^2)
  5. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 28 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG004
    title
    Stratum 2, Dose Level 3 (28 mg/m^2)
  6. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 36 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG005
    title
    Stratum 2, Dose Level 4 (36 mg/m^2)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      type
      Death
    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
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Did not receive study drug
    5. 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
      type
      Extended delay in start of next cycle for reasons unrelated to treatment
    6. 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
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Patient off-treatment for other complicating disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        12
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients with recurrent/progressive diffuse intrinsic pontine glioma (DIPG) were enrolled on stratum 1, and patients with non-progressed DIPG or H3K27M+ thalamic diffuse malignant glioma (DMG) were enrolled on stratum 2.
recruitment Details
Patients between 2 and 22 years of age (\>= 2, \< 22) at the time of enrollment were enrolled at Pediatric Brain Tumor Consortium (PBTC) member institutions. The first patient on study was enrolled on June 28, 2016, and the last patient was enrolled on November 10, 2021.

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Preserved source evidence · Not medical advice