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NCT01072175 · OUTCOME

Part C: Plasma Concentrations of Trametinib

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.

Measure
MEDIAN
Unit
ng/mL
Interval / dispersion
Full Range
Time frame
Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56

What was measured

Plasma concentrations of trametinib was assessed following daily dose of dabrafenib and trametinib.

Analysis population: PK Population. Only those participants who were available at the indicated time points were analyzed.

Groups in this outcome

Part C: Dabrafenib 150 mg

Participants received dabrafenib 150 mg gelatin capsules BID.

Part C: Dabrafenib 150 mg + Trametinib 1 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.

Part C: Dabrafenib 150 mg + Trametinib 2 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part C: Dabrafenib 150 mg59
Part C: Dabrafenib 150 mg + Trametinib 1 mg53
Part C: Dabrafenib 150 mg + Trametinib 2 mg50

Reported measurements

Day 15
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg0Not reported00Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg5.86Not reported3.411.3Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg9.35Not reported4.826.00Not reported
Week 8
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg0Not reported013.9Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg6.70Not reported2.09.6Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg10.3Not reported025.8Not reported
Week 16
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg0Not reported09.8Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg6.99Not reported020.7Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg9.87Not reported1.125.4Not reported
Week 24
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg0Not reported019.7Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg5.99Not reported011.2Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg9.54Not reported0.527.4Not reported
Week 32
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg0Not reported00Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg5.77Not reported0.711.6Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg9.74Not reported051.5Not reported
Week 40
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg0Not reported00Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg7.11Not reported2.216.7Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg10.1Not reported026.4Not reported
Week 48
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg0Not reported00Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg5.62Not reported014.3Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg10.3Not reported035.6Not reported
Week 56
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg0Not reported00Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg9.90Not reported3.416.9Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg8.60Not reported015.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        3.4
        upper Limit
        11.3
        value
        5.86
      3. group Id
        OG002
        lower Limit
        4.8
        upper Limit
        26.00
        value
        9.35
    title
    Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        13.9
        value
        0
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        9.6
        value
        6.70
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        25.8
        value
        10.3
    title
    Week 8
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        9.8
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        20.7
        value
        6.99
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        25.4
        value
        9.87
    title
    Week 16
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        19.7
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        11.2
        value
        5.99
      3. group Id
        OG002
        lower Limit
        0.5
        upper Limit
        27.4
        value
        9.54
    title
    Week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        11.6
        value
        5.77
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        51.5
        value
        9.74
    title
    Week 32
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        16.7
        value
        7.11
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        26.4
        value
        10.1
    title
    Week 40
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        14.3
        value
        5.62
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        35.6
        value
        10.3
    title
    Week 48
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        3.4
        upper Limit
        16.9
        value
        9.90
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        15.4
        value
        8.60
    title
    Week 56
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    2. group Id
      OG001
      value
      53
    3. group Id
      OG002
      value
      50
    units
    Participants
description
Plasma concentrations of trametinib was assessed following daily dose of dabrafenib and trametinib.
dispersion Type
Full Range
groups
  1. description
    Participants received dabrafenib 150 mg gelatin capsules BID.
    id
    OG000
    title
    Part C: Dabrafenib 150 mg
  2. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
    id
    OG001
    title
    Part C: Dabrafenib 150 mg + Trametinib 1 mg
  3. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
    id
    OG002
    title
    Part C: Dabrafenib 150 mg + Trametinib 2 mg
param Type
MEDIAN
population Description
PK Population. Only those participants who were available at the indicated time points were analyzed.
reporting Status
POSTED
time Frame
Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56
title
Part C: Plasma Concentrations of Trametinib
type
SECONDARY
unit Of Measure
ng/mL

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

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