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NCT05309668 · FLOW

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Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN · Source last updated 2026-08-13

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

groups
  1. description
    Global Cohort 1 (\>=4 to \<7 years)
    id
    FG000
    title
    Global Cohort 1
  2. description
    Global Cohort 2 (\>=1 to \<4 years)
    id
    FG001
    title
    Global Cohort 2
  3. description
    Japan Cohort (\>=1 to \<7 years)
    id
    FG002
    title
    Japan Cohort
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        4
      type
      Ongoing at data cut-off
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Eligible patients aged \>= 1 to \< 7 years at the time of informed consent with a diagnosis of NF1 with symptomatic inoperable PN fall into one of three cohorts: Global Cohort 1 (\>=4 to \<7 years), Global Cohort 2 (\>=1 to \<4 years), or Japan Cohort (\>=1 to \<7 years).
recruitment Details
The study is active, not recruiting and conducted in 7 countries with 39 patients who gave informed consent on or prior to 15 January 2024. Results are reported for the study at data cut-off 1 (DCO1) 08 April 2024.
Complete source fields
groups
  1. description
    Global Cohort 1 (\>=4 to \<7 years)
    id
    FG000
    title
    Global Cohort 1
  2. description
    Global Cohort 2 (\>=1 to \<4 years)
    id
    FG001
    title
    Global Cohort 2
  3. description
    Japan Cohort (\>=1 to \<7 years)
    id
    FG002
    title
    Japan Cohort
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        4
      type
      Ongoing at data cut-off
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Eligible patients aged \>= 1 to \< 7 years at the time of informed consent with a diagnosis of NF1 with symptomatic inoperable PN fall into one of three cohorts: Global Cohort 1 (\>=4 to \<7 years), Global Cohort 2 (\>=1 to \<4 years), or Japan Cohort (\>=1 to \<7 years).
recruitment Details
The study is active, not recruiting and conducted in 7 countries with 39 patients who gave informed consent on or prior to 15 January 2024. Results are reported for the study at data cut-off 1 (DCO1) 08 April 2024.

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Preserved source evidence · Not medical advice