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NCT01597908 · FLOW

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Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma · Source last updated 2021-02-24

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

groups
  1. description
    Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    FG000
    title
    Dabrafenib Plus Trametinib
  2. description
    Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    FG001
    title
    Vemurafenib
  3. description
    With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
    id
    FG002
    title
    Crossover Dabrafenib Plus Trametinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        217
      2. group Id
        FG001
        num Subjects
        238
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        93
      2. group Id
        FG001
        num Subjects
        39
      3. group Id
        FG002
        num Subjects
        0
      type
      Sponsor Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        0
      type
      Crossover to Dabrafenib&Trametinib
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        352
      2. group Id
        FG001
        num Subjects
        352
      3. group Id
        FG002
        num Subjects
        0
      comment
      All randomized patients included into Intent-to-Treat (ITT) population.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        350
      2. group Id
        FG001
        num Subjects
        349
      3. group Id
        FG002
        num Subjects
        0
      comment
      All patients who received at least one dose of study treatment
      type
      Safety Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      ongoing status (incomplete end-of-study data and never received study treatment)
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        351
      2. group Id
        FG001
        num Subjects
        352
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomized Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        20
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        34
      comment
      All crossover randomized patients included into ITT \& Safety Sets
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Crossover Phase
pre Assignment Details
694 subjects were planned and 704 subjects (352 each in combination therapy arm and vemurafenib monotherapy arm) were actually randomized and analyzed. Subjects were stratified by LDH level (\> the ULN versus ≤ ULN) and BRAF mutation (V600E versus V600K).
recruitment Details
This study was conducted at 207 centers in 28 countries worldwide (Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, South Korea, Netherlands, New Zealand, Norway, Poland, Russian Federation, Spain, Sweden,Switzerland, Taiwan, Ukraine, UK and USA).
Complete source fields
groups
  1. description
    Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    FG000
    title
    Dabrafenib Plus Trametinib
  2. description
    Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    FG001
    title
    Vemurafenib
  3. description
    With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
    id
    FG002
    title
    Crossover Dabrafenib Plus Trametinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        217
      2. group Id
        FG001
        num Subjects
        238
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        93
      2. group Id
        FG001
        num Subjects
        39
      3. group Id
        FG002
        num Subjects
        0
      type
      Sponsor Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        0
      type
      Crossover to Dabrafenib&Trametinib
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        352
      2. group Id
        FG001
        num Subjects
        352
      3. group Id
        FG002
        num Subjects
        0
      comment
      All randomized patients included into Intent-to-Treat (ITT) population.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        350
      2. group Id
        FG001
        num Subjects
        349
      3. group Id
        FG002
        num Subjects
        0
      comment
      All patients who received at least one dose of study treatment
      type
      Safety Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      ongoing status (incomplete end-of-study data and never received study treatment)
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        351
      2. group Id
        FG001
        num Subjects
        352
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomized Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        20
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        34
      comment
      All crossover randomized patients included into ITT \& Safety Sets
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Crossover Phase
pre Assignment Details
694 subjects were planned and 704 subjects (352 each in combination therapy arm and vemurafenib monotherapy arm) were actually randomized and analyzed. Subjects were stratified by LDH level (\> the ULN versus ≤ ULN) and BRAF mutation (V600E versus V600K).
recruitment Details
This study was conducted at 207 centers in 28 countries worldwide (Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, South Korea, Netherlands, New Zealand, Norway, Poland, Russian Federation, Spain, Sweden,Switzerland, Taiwan, Ukraine, UK and USA).

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

Preserved source evidence · Independent clinical review pending · Not medical advice