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NCT01072175 · OUTCOME

Part C: Plasma Concentrations of Dabrafenib and Its Metabolites

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 dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were assesed 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 mg49
Part C: Dabrafenib 150 mg + Trametinib 1 mg53
Part C: Dabrafenib 150 mg + Trametinib 2 mg50

Reported measurements

Day 15, GSK2118436
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg59.3Not reported92420Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg68.2Not reported01555Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg66.3Not reported71804Not reported
Week 8, GSK2118436
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg45.6Not reported31841Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg69.8Not reported0946Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg50.5Not reported01696Not reported
Week 16, GSK2118436
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg84.4Not reported01865Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg66.7Not reported01774Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg82.9Not reported23033Not reported
Week 24, GSK2118436
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg66.3Not reported4594Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg66.2Not reported12684Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg93.3Not reported7741Not reported
Week 32, GSK2118436
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg40.6Not reported1500Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg57.1Not reported01424Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg66.4Not reported02042Not reported
Week 40, GSK2118436
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg229Not reported5714Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg97.6Not reported192597Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg150.9Not reported01624Not reported
Week 48, GSK2118436
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg44.7Not reported13132Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg105.6Not reported01322Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg107.7Not reported3806Not reported
Week 56, GSK2118436
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg46.4Not reported2568Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg44.5Not reported06646Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg193.8Not reported3413Not reported
Day 15, GSK2285403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg92.7Not reported141337Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg71.8Not reported21220Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg90.5Not reported10995Not reported
Week 8, GSK2285403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg65.2Not reported32041Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg80.4Not reported0769Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg90.6Not reported0757Not reported
Week 16, GSK2285403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg113.4Not reported02090Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg81.9Not reported0995Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg114.7Not reported32563Not reported
Week 24, GSK2285403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg95.0Not reported4616Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg88.1Not reported01689Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg130.2Not reported9529Not reported
Week 32, GSK2285403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg62.5Not reported3890Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg86.7Not reported0808Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg87.4Not reported0973Not reported
Week 40, GSK2285403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg263.8Not reported7693Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg143.5Not reported16870Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg136.2Not reported01665Not reported
Week 48, GSK2285403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg43.3Not reported32241Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg93.6Not reported0898Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg146.4Not reported2418Not reported
Week 56, GSK2285403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg48.3Not reported4551Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg92.9Not reported01841Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg141.5Not reported7755Not reported
Day 15, GSK2298683
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg3493Not reported138116820Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg3043.3Not reported1998562Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg3145.8Not reported42816240Not reported
Week 8, GSK2298683
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg3149.7Not reported23813330Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg3238.4Not reported207686Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg3010Not reported3113130Not reported
Week 16, GSK2298683
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg3497.9Not reported219952Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg2946.1Not reported08782Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg2756.5Not reported4414004Not reported
Week 24, GSK2298683
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg2876.5Not reported5008635Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg3365.4Not reported257482Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg3193.7Not reported1336531Not reported
Week 32, GSK2298683
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg2699.9Not reported44714341Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg3267.1Not reported09278Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg3046.8Not reported509077Not reported
Week 40, GSK2298683
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg4410.6Not reported102314258Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg3694.7Not reported19007663Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg3492.8Not reported012550Not reported
Week 48, GSK2298683
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg3554.9Not reported18897148Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg4146.9Not reported08351Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg3936.1Not reported46412239Not reported
Week 56, GSK2298683
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg2032.2Not reported11022963Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg3843.5Not reported3746866Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg2904.9Not reported13054673Not reported
Day 15, GSK2167542
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg247.9Not reported95955Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg288Not reported491164Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg289.3Not reported721140Not reported
Week 8, GSK2167542
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg239.5Not reported191092Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg275.2Not reported3983Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg262.4Not reported09876Not reported
Week 16, GSK2167542
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg244Not reported1772Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg204.4Not reported0922Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg243.8Not reported31049Not reported
Week 24, GSK2167542
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg225.6Not reported48899Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg247.2Not reported4990Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg254.6Not reported3846Not reported
Week 32, GSK2167542
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg171Not reported19544Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg255.4Not reported0698Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg289.3Not reported2962Not reported
Week 40, GSK2167542
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg222.2Not reported95639Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg249.3Not reported55674Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg268.9Not reported0910Not reported
Week 48, GSK2167542
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg204.5Not reported145286Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg232Not reported0915Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg260.9Not reported81886Not reported
Week 56, GSK2167542
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg171.8Not reported116228Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg250Not reported28851Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg462.1Not reported107663Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9
        upper Limit
        2420
        value
        59.3
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1555
        value
        68.2
      3. group Id
        OG002
        lower Limit
        7
        upper Limit
        1804
        value
        66.3
    title
    Day 15, GSK2118436
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        1841
        value
        45.6
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        946
        value
        69.8
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        1696
        value
        50.5
    title
    Week 8, GSK2118436
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        1865
        value
        84.4
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1774
        value
        66.7
      3. group Id
        OG002
        lower Limit
        2
        upper Limit
        3033
        value
        82.9
    title
    Week 16, GSK2118436
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        594
        value
        66.3
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        2684
        value
        66.2
      3. group Id
        OG002
        lower Limit
        7
        upper Limit
        741
        value
        93.3
    title
    Week 24, GSK2118436
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        500
        value
        40.6
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1424
        value
        57.1
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        2042
        value
        66.4
    title
    Week 32, GSK2118436
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5
        upper Limit
        714
        value
        229
      2. group Id
        OG001
        lower Limit
        19
        upper Limit
        2597
        value
        97.6
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        1624
        value
        150.9
    title
    Week 40, GSK2118436
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13
        upper Limit
        132
        value
        44.7
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1322
        value
        105.6
      3. group Id
        OG002
        lower Limit
        3
        upper Limit
        806
        value
        107.7
    title
    Week 48, GSK2118436
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25
        upper Limit
        68
        value
        46.4
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        6646
        value
        44.5
      3. group Id
        OG002
        lower Limit
        3
        upper Limit
        413
        value
        193.8
    title
    Week 56, GSK2118436
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14
        upper Limit
        1337
        value
        92.7
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        1220
        value
        71.8
      3. group Id
        OG002
        lower Limit
        10
        upper Limit
        995
        value
        90.5
    title
    Day 15, GSK2285403
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        2041
        value
        65.2
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        769
        value
        80.4
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        757
        value
        90.6
    title
    Week 8, GSK2285403
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2090
        value
        113.4
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        995
        value
        81.9
      3. group Id
        OG002
        lower Limit
        3
        upper Limit
        2563
        value
        114.7
    title
    Week 16, GSK2285403
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        616
        value
        95.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1689
        value
        88.1
      3. group Id
        OG002
        lower Limit
        9
        upper Limit
        529
        value
        130.2
    title
    Week 24, GSK2285403
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      53
    3. group Id
      OG002
      value
      50
    units
    Participants
description
Plasma concentrations of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were assesed 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 Dabrafenib and Its Metabolites
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