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NCT04439318 · FLOW

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Testing Trametinib as a Potential Targeted Treatment in Cancers With NF1 Genetic Changes (MATCH-Subprotocol S1) · Source last updated 2026-07-17

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

groups
  1. description
    Patients receive trametinib dimethyl sulfoxide 2mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment (Trametinib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Never Started Treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Other Complicating Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Patient Refusal - Prefers Different Therapy
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Non-Compliance
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Still on Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        50
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        49
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        46
      comment
      Three patients never started treatment. This is the primary analysis population.
      type
      Eligible and Started Protocol Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        50
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol S1, patients had to have a qualifying NF1 actionable mutation.
recruitment Details
Eighty-one patients were assigned to Subprotocol S1 after screening, all from screening cohort. Of the 81 patients, 50 patients were enrolled in arm S1 between March 2016 and July 2017.
Complete source fields
groups
  1. description
    Patients receive trametinib dimethyl sulfoxide 2mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment (Trametinib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Never Started Treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Other Complicating Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Patient Refusal - Prefers Different Therapy
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Non-Compliance
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Still on Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        50
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        49
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        46
      comment
      Three patients never started treatment. This is the primary analysis population.
      type
      Eligible and Started Protocol Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        50
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol S1, patients had to have a qualifying NF1 actionable mutation.
recruitment Details
Eighty-one patients were assigned to Subprotocol S1 after screening, all from screening cohort. Of the 81 patients, 50 patients were enrolled in arm S1 between March 2016 and July 2017.

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Preserved source evidence · Not medical advice