Skip to content
TriangleGet started
← Full study record

NCT02124772 · BASELINE

Baseline characteristics

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations · Source last updated 2021-07-14

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

denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      19
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      16
    5. group Id
      BG004
      value
      11
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      10
    9. group Id
      BG008
      value
      3
    10. group Id
      BG009
      value
      9
    11. group Id
      BG010
      value
      6
    12. group Id
      BG011
      value
      20
    units
    Participants
groups
  1. description
    Participants treated with trametinib 0.0125 mg/kg/day
    id
    BG000
    title
    Part A - TMT 0.0125 mg/kg/Day
  2. description
    Participants treated with trametinib 0.025 mg/kg/day
    id
    BG001
    title
    Part A - TMT 0.025 mg/kg/Day
  3. description
    Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
    id
    BG002
    title
    Part A - TMT 0.032 mg/kg/Day
  4. description
    Participants treated with trametinib 0.04 mg/kg/day
    id
    BG003
    title
    Part A - TMT 0.04 mg/kg/Day
  5. description
    Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
    id
    BG004
    title
    Part B - Neuroblastoma
  6. description
    Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
    id
    BG005
    title
    Part B - LGG Fusion
  7. description
    Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
    id
    BG006
    title
    Part B - NF-1 With PN
  8. description
    Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
    id
    BG007
    title
    Part B - BRAF V600 Mutant Solid Tumor
  9. description
    Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
    id
    BG008
    title
    Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D
  10. description
    Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
    id
    BG009
    title
    Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D
  11. description
    Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
    id
    BG010
    title
    Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D
  12. description
    Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
    id
    BG011
    title
    Part D - LGG
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        < 2 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          2
        title
        2 - <6 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          9
        title
        6 - <12 years
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          9
        title
        ≥ 12 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          10
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          16
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      19
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      16
    5. group Id
      BG004
      value
      11
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      10
    9. group Id
      BG008
      value
      3
    10. group Id
      BG009
      value
      9
    11. group Id
      BG010
      value
      6
    12. group Id
      BG011
      value
      20
    units
    Participants
groups
  1. description
    Participants treated with trametinib 0.0125 mg/kg/day
    id
    BG000
    title
    Part A - TMT 0.0125 mg/kg/Day
  2. description
    Participants treated with trametinib 0.025 mg/kg/day
    id
    BG001
    title
    Part A - TMT 0.025 mg/kg/Day
  3. description
    Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
    id
    BG002
    title
    Part A - TMT 0.032 mg/kg/Day
  4. description
    Participants treated with trametinib 0.04 mg/kg/day
    id
    BG003
    title
    Part A - TMT 0.04 mg/kg/Day
  5. description
    Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
    id
    BG004
    title
    Part B - Neuroblastoma
  6. description
    Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
    id
    BG005
    title
    Part B - LGG Fusion
  7. description
    Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
    id
    BG006
    title
    Part B - NF-1 With PN
  8. description
    Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
    id
    BG007
    title
    Part B - BRAF V600 Mutant Solid Tumor
  9. description
    Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
    id
    BG008
    title
    Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D
  10. description
    Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
    id
    BG009
    title
    Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D
  11. description
    Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
    id
    BG010
    title
    Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D
  12. description
    Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
    id
    BG011
    title
    Part D - LGG
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        < 2 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          2
        title
        2 - <6 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          9
        title
        6 - <12 years
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          9
        title
        ≥ 12 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          10
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          16
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

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