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NCT02039947 · FLOW

Participant flow

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain · Source last updated 2019-05-21

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

groups
  1. description
    Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
    id
    FG000
    title
    Cohort A
  2. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    FG001
    title
    Cohort B
  3. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    FG002
    title
    Cohort C
  4. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    FG003
    title
    Cohort D
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        17
      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
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A subject was considered to have completed the study if the subject died during the study treatment or follow-up period or (for subject in Cohort A) had at least 3 years follow-up from the date of first dose of study treatment at the end of the study. All subjects achieved that definition and then the study ended.
Complete source fields
groups
  1. description
    Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
    id
    FG000
    title
    Cohort A
  2. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    FG001
    title
    Cohort B
  3. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    FG002
    title
    Cohort C
  4. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    FG003
    title
    Cohort D
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        17
      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
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A subject was considered to have completed the study if the subject died during the study treatment or follow-up period or (for subject in Cohort A) had at least 3 years follow-up from the date of first dose of study treatment at the end of the study. All subjects achieved that definition and then the study ended.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice