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NCT01072175 · BASELINE

Baseline characteristics

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05

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
      8
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      23
    4. group Id
      BG003
      value
      27
    5. group Id
      BG004
      value
      94
    6. group Id
      BG005
      value
      54
    7. group Id
      BG006
      value
      54
    8. group Id
      BG007
      value
      54
    9. group Id
      BG008
      value
      12
    10. group Id
      BG009
      value
      16
    11. group Id
      BG010
      value
      43
    12. group Id
      BG011
      value
      39
    units
    Participants
groups
  1. description
    Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
    id
    BG000
    title
    Part A: Dabrafenib 75 mg + Trametinib 2 mg
  2. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
    id
    BG001
    title
    Part B: Dabrafenib 75 mg + Trametinib 1 mg
  3. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
    id
    BG002
    title
    Part B: Dabrafenib 150 mg + Trametinib 1 mg
  4. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
    id
    BG003
    title
    Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
  5. description
    Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
    id
    BG004
    title
    Part B: Dabrafenib 150 mg + Trametinib 2 mg
  6. description
    Participants received dabrafenib 150 mg gelatin capsules BID.
    id
    BG005
    title
    Part C: Dabrafenib 150 mg
  7. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
    id
    BG006
    title
    Part C: Dabrafenib 150 mg + Trametinib 1 mg
  8. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
    id
    BG007
    title
    Part C: Dabrafenib 150 mg + Trametinib 2 mg
  9. description
    Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
    id
    BG008
    title
    Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
  10. description
    Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
    id
    BG009
    title
    Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
  11. description
    Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
    id
    BG010
    title
    Part D: Dabrafenib 75 mg + Trametinib 2 mg
  12. description
    Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
    id
    BG011
    title
    Part D: Dabrafenib 150 mg + Trametinib 2 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.04
          value
          52.8
        2. group Id
          BG001
          spread
          7.28
          value
          48.2
        3. group Id
          BG002
          spread
          13.24
          value
          54.2
        4. group Id
          BG003
          spread
          12.09
          value
          52.2
        5. group Id
          BG004
          spread
          12.99
          value
          52.4
        6. group Id
          BG005
          spread
          15.19
          value
          51.8
        7. group Id
          BG006
          spread
          14.70
          value
          49.9
        8. group Id
          BG007
          spread
          11.85
          value
          55.9
        9. group Id
          BG008
          spread
          12.39
          value
          51.8
        10. group Id
          BG009
          spread
          17.04
          value
          53.1
        11. group Id
          BG010
          spread
          14.57
          value
          52.8
        12. group Id
          BG011
          spread
          14.08
          value
          56.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          56
        6. group Id
          BG005
          value
          25
        7. group Id
          BG006
          value
          24
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          18
        12. group Id
          BG011
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          38
        6. group Id
          BG005
          value
          29
        7. group Id
          BG006
          value
          30
        8. group Id
          BG007
          value
          34
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          25
        12. group Id
          BG011
          value
          25
        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
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          92
        6. group Id
          BG005
          value
          52
        7. group Id
          BG006
          value
          54
        8. group Id
          BG007
          value
          53
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          16
        11. group Id
          BG010
          value
          43
        12. group Id
          BG011
          value
          39
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        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
      Asian
    3. 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
          1
        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
      African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        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
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      8
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      23
    4. group Id
      BG003
      value
      27
    5. group Id
      BG004
      value
      94
    6. group Id
      BG005
      value
      54
    7. group Id
      BG006
      value
      54
    8. group Id
      BG007
      value
      54
    9. group Id
      BG008
      value
      12
    10. group Id
      BG009
      value
      16
    11. group Id
      BG010
      value
      43
    12. group Id
      BG011
      value
      39
    units
    Participants
groups
  1. description
    Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
    id
    BG000
    title
    Part A: Dabrafenib 75 mg + Trametinib 2 mg
  2. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
    id
    BG001
    title
    Part B: Dabrafenib 75 mg + Trametinib 1 mg
  3. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
    id
    BG002
    title
    Part B: Dabrafenib 150 mg + Trametinib 1 mg
  4. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
    id
    BG003
    title
    Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
  5. description
    Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
    id
    BG004
    title
    Part B: Dabrafenib 150 mg + Trametinib 2 mg
  6. description
    Participants received dabrafenib 150 mg gelatin capsules BID.
    id
    BG005
    title
    Part C: Dabrafenib 150 mg
  7. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
    id
    BG006
    title
    Part C: Dabrafenib 150 mg + Trametinib 1 mg
  8. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
    id
    BG007
    title
    Part C: Dabrafenib 150 mg + Trametinib 2 mg
  9. description
    Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
    id
    BG008
    title
    Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
  10. description
    Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
    id
    BG009
    title
    Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
  11. description
    Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
    id
    BG010
    title
    Part D: Dabrafenib 75 mg + Trametinib 2 mg
  12. description
    Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
    id
    BG011
    title
    Part D: Dabrafenib 150 mg + Trametinib 2 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.04
          value
          52.8
        2. group Id
          BG001
          spread
          7.28
          value
          48.2
        3. group Id
          BG002
          spread
          13.24
          value
          54.2
        4. group Id
          BG003
          spread
          12.09
          value
          52.2
        5. group Id
          BG004
          spread
          12.99
          value
          52.4
        6. group Id
          BG005
          spread
          15.19
          value
          51.8
        7. group Id
          BG006
          spread
          14.70
          value
          49.9
        8. group Id
          BG007
          spread
          11.85
          value
          55.9
        9. group Id
          BG008
          spread
          12.39
          value
          51.8
        10. group Id
          BG009
          spread
          17.04
          value
          53.1
        11. group Id
          BG010
          spread
          14.57
          value
          52.8
        12. group Id
          BG011
          spread
          14.08
          value
          56.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          56
        6. group Id
          BG005
          value
          25
        7. group Id
          BG006
          value
          24
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          18
        12. group Id
          BG011
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          38
        6. group Id
          BG005
          value
          29
        7. group Id
          BG006
          value
          30
        8. group Id
          BG007
          value
          34
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          25
        12. group Id
          BG011
          value
          25
        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
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          92
        6. group Id
          BG005
          value
          52
        7. group Id
          BG006
          value
          54
        8. group Id
          BG007
          value
          53
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          16
        11. group Id
          BG010
          value
          43
        12. group Id
          BG011
          value
          39
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        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
      Asian
    3. 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
          1
        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
      African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        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
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

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