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NCT02684058 · FLOW

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Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors · Source last updated 2023-12-13

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

groups
  1. description
    Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
    id
    FG000
    title
    LGG Cohort: Dabrafenib and Trametinib
  2. description
    Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.
    id
    FG001
    title
    LGG Cohort: Carboplatin and Vincristine
  3. description
    Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
    id
    FG002
    title
    HGG Cohort: Dabrafenib and Trametinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        19
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      New therapy for study indication
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol deviation
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Subject/guardian decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        41
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        41
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        17
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Subject/guardian decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      New therapy for study indication
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        5
      comment
      Participants who discontinued study treatment for reasons other than disease progression, death, loss to follow up, or withdrawal of consent
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Post-treatment Efficacy Follow-up
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      comment
      Alive at the end of the study
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Post-treatment Survival Follow-up
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        0
      comment
      Participants randomized to the carboplatin with vincristine treatment arm were allowed to cross-over to receive dabrafenib in combination with trametinib treatment after centrally confirmed and RANO-defined disease progression
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Crossover Treatment Period
pre Assignment Details
Pediatric patients for both cohorts were screened for eligibility during the 28 days immediately prior to starting study treatment on Day 1. In the LGG cohort, 121 patients were screened of whom 110 patients were randomized in a 2:1 ratio to the dabrafenib and trametinib arm or the carboplatin with vincristine arm. 4 participants randomized to chemotherapy arm were never treated. In the HGG cohort, 46 patients were screened of whom 41 patients entered the HGG cohort
recruitment Details
The study was conducted in 58 centers across 20 countries
Complete source fields
groups
  1. description
    Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
    id
    FG000
    title
    LGG Cohort: Dabrafenib and Trametinib
  2. description
    Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.
    id
    FG001
    title
    LGG Cohort: Carboplatin and Vincristine
  3. description
    Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
    id
    FG002
    title
    HGG Cohort: Dabrafenib and Trametinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        19
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      New therapy for study indication
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol deviation
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Subject/guardian decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        41
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        41
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        17
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Subject/guardian decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      New therapy for study indication
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        5
      comment
      Participants who discontinued study treatment for reasons other than disease progression, death, loss to follow up, or withdrawal of consent
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Post-treatment Efficacy Follow-up
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      comment
      Alive at the end of the study
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Post-treatment Survival Follow-up
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        0
      comment
      Participants randomized to the carboplatin with vincristine treatment arm were allowed to cross-over to receive dabrafenib in combination with trametinib treatment after centrally confirmed and RANO-defined disease progression
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Crossover Treatment Period
pre Assignment Details
Pediatric patients for both cohorts were screened for eligibility during the 28 days immediately prior to starting study treatment on Day 1. In the LGG cohort, 121 patients were screened of whom 110 patients were randomized in a 2:1 ratio to the dabrafenib and trametinib arm or the carboplatin with vincristine arm. 4 participants randomized to chemotherapy arm were never treated. In the HGG cohort, 46 patients were screened of whom 41 patients entered the HGG cohort
recruitment Details
The study was conducted in 58 centers across 20 countries

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