Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01266967 · OUTCOME

Median Concentrations of GSK2118436 and Its Metabolites Including GSK2285403, GSK2298683, and GSK2167542

A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain · Source last updated 2014-05-08

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

Measure
MEDIAN
Unit
nanograms per milliliter (ng/mL)
Interval / dispersion
Full Range
Time frame
Week 4 (pre-dose and 1-3 hours post-dose) and Weeks 8, 16, 24, and 32 (either pre-dose in the morning or in the afternoon at 4-8 hours post-dose)

What was measured

Summary statistics were calculated for each time point by cohort. The population pharmacokinetics were determined using a non-linear mixed effects modeling approach after pooling the data with other studies. These results are reported separately.

Analysis population: PK Population: participants in the ATS population for whom a PK sample was obtained and analyzed. Only those participants whose samples were available at the indicated time points were analyzed.

Groups in this outcome

GSK2118436 150 mg: No Prior Local Therapy

Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

GSK2118436 150 mg: Prior Local Therapy

Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

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

Analysis denominator · Participants

GroupSource count
GSK2118436 150 mg: No Prior Local Therapy75
GSK2118436 150 mg: Prior Local Therapy77

Reported measurements

GSK2118436, Week 4, predose, n=55, 58
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy31.6Not reported72995Not reported
GSK2118436 150 mg: Prior Local Therapy50.2Not reported04293Not reported
GSK2118436, Week 4, 1-3 hours (hrs), n=63, 70
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy992.1Not reported54870Not reported
GSK2118436 150 mg: Prior Local Therapy810.7Not reported44995Not reported
GSK2118436, Week 8, predose, n=36, 36
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy27.2Not reported81148Not reported
GSK2118436 150 mg: Prior Local Therapy37.5Not reported3944Not reported
GSK2118436, Week 8, 4-8 hrs, n=19, 25
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy274.7Not reported281062Not reported
GSK2118436 150 mg: Prior Local Therapy294.5Not reported152011Not reported
GSK2118436, Week 16, predose, n=26, 23
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy27.8Not reported63390Not reported
GSK2118436 150 mg: Prior Local Therapy30.7Not reported3203Not reported
GSK2118436, Week 16, 4-8 hrs, n=11, 18
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy341.5Not reported331141Not reported
GSK2118436 150 mg: Prior Local Therapy295.8Not reported551808Not reported
GSK2118436, Week 24, predose, n=14, 10
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy60.7Not reported1597Not reported
GSK2118436 150 mg: Prior Local Therapy53.8Not reported14211Not reported
GSK2118436, Week 24, 4-8 hrs, n=5, 12
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy371.2Not reported01072Not reported
GSK2118436 150 mg: Prior Local Therapy226.1Not reported30974Not reported
GSK2118436, Week 32, predose, n=11, 7
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy38.6Not reported7777126Not reported
GSK2118436 150 mg: Prior Local Therapy28.4Not reported287Not reported
GSK2118436, Week 32, 4-8 hrs, n=2, 8
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy227.6Not reported90365Not reported
GSK2118436 150 mg: Prior Local Therapy335.7Not reported941939Not reported
GSK2285403, Week 4, predose, n=55, 58
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy62.7Not reported91495Not reported
GSK2118436 150 mg: Prior Local Therapy80.5Not reported02931Not reported
GSK2285403, Week 4, 1-3 hrs, n=63, 70
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy688.9Not reported152499Not reported
GSK2118436 150 mg: Prior Local Therapy593.2Not reported82812Not reported
GSK2285403, Week 8, predose, n=36, 36
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy46.5Not reported101743Not reported
GSK2118436 150 mg: Prior Local Therapy74.4Not reported6553Not reported
GSK2285403, Week 8, 4-8 hrs, n=19, 25
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy335.5Not reported551114Not reported
GSK2118436 150 mg: Prior Local Therapy310.5Not reported123160Not reported
GSK2285403, Week 16, predose, n=26, 23
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy45.1Not reported10824Not reported
GSK2118436 150 mg: Prior Local Therapy54.4Not reported5354Not reported
GSK2285403, Week 16, 4-8 hrs, n=11, 18
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy434.1Not reported44976Not reported
GSK2118436 150 mg: Prior Local Therapy456.9Not reported1481053Not reported
GSK2285403, Week 24, predose, n=14, 10
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy97.3Not reported6386Not reported
GSK2118436 150 mg: Prior Local Therapy103.3Not reported14325Not reported
GSK2285403, Week 24, 4-8 hrs, n=5, 12
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy617.1Not reported01057Not reported
GSK2118436 150 mg: Prior Local Therapy357.7Not reported79959Not reported
GSK2285403, Week 32, predose, n=11, 7
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy63.1Not reported8934Not reported
GSK2118436 150 mg: Prior Local Therapy46.6Not reported488Not reported
GSK2285403, Week 32, 4-8 hrs, n=2, 8
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy375.3Not reported118633Not reported
GSK2118436 150 mg: Prior Local Therapy377.5Not reported1171519Not reported
GSK2298683, Week 4, predose, n=55, 58
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy3215.8Not reported122514064Not reported
GSK2118436 150 mg: Prior Local Therapy3877.4Not reported4313435Not reported
GSK2298683, Week 4, 1-3 hrs, n=63, 70
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy4272.5Not reported74718161Not reported
GSK2118436 150 mg: Prior Local Therapy4500.3Not reported27518196Not reported
GSK2298683, Week 8, predose, n=36, 36
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy3152.0Not reported156410402Not reported
GSK2118436 150 mg: Prior Local Therapy3250.0Not reported66712747Not reported
GSK2298683, Week 8, 4-8 hrs, n=19, 25
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy4692.1Not reported213311320Not reported
GSK2118436 150 mg: Prior Local Therapy5447.5Not reported201515009Not reported
GSK2298683, Week 16, predose, n=26, 23
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy3070.0Not reported114311414Not reported
GSK2118436 150 mg: Prior Local Therapy3561.2Not reported92210204Not reported
GSK2298683, Week 16, 4-8 hrs, n=11, 18
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy4865.5Not reported267011821Not reported
GSK2118436 150 mg: Prior Local Therapy6595.7Not reported163011380Not reported
GSK2298683, Week 24, predose, n=14, 10
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy3026.8Not reported153214762Not reported
GSK2118436 150 mg: Prior Local Therapy4199.7Not reported20407504Not reported
GSK2298683, Week 24, 4-8 hrs, n=5, 12
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy3825.9Not reported32013056Not reported
GSK2118436 150 mg: Prior Local Therapy5659.9Not reported322511009Not reported
GSK2298683, Week 32, predose, n=11, 7
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy2386.6Not reported14216528Not reported
GSK2118436 150 mg: Prior Local Therapy2451.7Not reported12535026Not reported
GSK2298683, Week 32, 4-8 hrs, n=2, 8
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy11225.8Not reported532317129Not reported
GSK2118436 150 mg: Prior Local Therapy6547.4Not reported45788786Not reported
GSK2167542, Week 4, predose, n=55, 58
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy317.9Not reported501338Not reported
GSK2118436 150 mg: Prior Local Therapy323.0Not reported32690Not reported
GSK2167542, Week 4, 1-3 hrs, n=63, 70
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy351.6Not reported621505Not reported
GSK2118436 150 mg: Prior Local Therapy332.1Not reported461619Not reported
GSK2167542, Week 8, predose, n=36, 36
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy324.1Not reported86964Not reported
GSK2118436 150 mg: Prior Local Therapy298.6Not reported561272Not reported
GSK2167542, Week 8, 4-8 hrs, n=19, 25
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy305.4Not reported91899Not reported
GSK2118436 150 mg: Prior Local Therapy320.5Not reported78960Not reported
GSK2167542, Week 16, predose, n=26, 23
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy285.5Not reported931095Not reported
GSK2118436 150 mg: Prior Local Therapy310.8Not reported351200Not reported
GSK2167542, Week 16, 4-8 hrs, n=11, 18
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy291.1Not reported69769Not reported
GSK2118436 150 mg: Prior Local Therapy320.5Not reported81652Not reported
GSK2167542, Week 24, predose, n=14, 10
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy304.0Not reported94875Not reported
GSK2118436 150 mg: Prior Local Therapy334.0Not reported63795Not reported
GSK2167542, Week 24, 4-8 hrs, n=5, 12
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy190.7Not reported19401Not reported
GSK2118436 150 mg: Prior Local Therapy287.9Not reported106599Not reported
GSK2167542, Week 32, predose, n=11, 2
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy361.2Not reported113960Not reported
GSK2118436 150 mg: Prior Local Therapy316.3Not reported69690Not reported
GSK2167542, Week 32, 4-8 hrs, n=2, 8
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy227.8Not reported225231Not reported
GSK2118436 150 mg: Prior Local Therapy273.9Not reported2311021Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        2995
        value
        31.6
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        4293
        value
        50.2
    title
    GSK2118436, Week 4, predose, n=55, 58
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5
        upper Limit
        4870
        value
        992.1
      2. group Id
        OG001
        lower Limit
        4
        upper Limit
        4995
        value
        810.7
    title
    GSK2118436, Week 4, 1-3 hours (hrs), n=63, 70
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8
        upper Limit
        1148
        value
        27.2
      2. group Id
        OG001
        lower Limit
        3
        upper Limit
        944
        value
        37.5
    title
    GSK2118436, Week 8, predose, n=36, 36
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28
        upper Limit
        1062
        value
        274.7
      2. group Id
        OG001
        lower Limit
        15
        upper Limit
        2011
        value
        294.5
    title
    GSK2118436, Week 8, 4-8 hrs, n=19, 25
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        3390
        value
        27.8
      2. group Id
        OG001
        lower Limit
        3
        upper Limit
        203
        value
        30.7
    title
    GSK2118436, Week 16, predose, n=26, 23
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33
        upper Limit
        1141
        value
        341.5
      2. group Id
        OG001
        lower Limit
        55
        upper Limit
        1808
        value
        295.8
    title
    GSK2118436, Week 16, 4-8 hrs, n=11, 18
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        597
        value
        60.7
      2. group Id
        OG001
        lower Limit
        14
        upper Limit
        211
        value
        53.8
    title
    GSK2118436, Week 24, predose, n=14, 10
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        1072
        value
        371.2
      2. group Id
        OG001
        lower Limit
        30
        upper Limit
        974
        value
        226.1
    title
    GSK2118436, Week 24, 4-8 hrs, n=5, 12
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        777126
        value
        38.6
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        87
        value
        28.4
    title
    GSK2118436, Week 32, predose, n=11, 7
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        365
        value
        227.6
      2. group Id
        OG001
        lower Limit
        94
        upper Limit
        1939
        value
        335.7
    title
    GSK2118436, Week 32, 4-8 hrs, n=2, 8
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9
        upper Limit
        1495
        value
        62.7
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        2931
        value
        80.5
    title
    GSK2285403, Week 4, predose, n=55, 58
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15
        upper Limit
        2499
        value
        688.9
      2. group Id
        OG001
        lower Limit
        8
        upper Limit
        2812
        value
        593.2
    title
    GSK2285403, Week 4, 1-3 hrs, n=63, 70
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      77
    units
    Participants
description
Summary statistics were calculated for each time point by cohort. The population pharmacokinetics were determined using a non-linear mixed effects modeling approach after pooling the data with other studies. These results are reported separately.
dispersion Type
Full Range
groups
  1. description
    Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
    id
    OG000
    title
    GSK2118436 150 mg: No Prior Local Therapy
  2. description
    Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
    id
    OG001
    title
    GSK2118436 150 mg: Prior Local Therapy
param Type
MEDIAN
population Description
PK Population: participants in the ATS population for whom a PK sample was obtained and analyzed. Only those participants whose samples were available at the indicated time points were analyzed.
reporting Status
POSTED
time Frame
Week 4 (pre-dose and 1-3 hours post-dose) and Weeks 8, 16, 24, and 32 (either pre-dose in the morning or in the afternoon at 4-8 hours post-dose)
title
Median Concentrations of GSK2118436 and Its Metabolites Including GSK2285403, GSK2298683, and GSK2167542
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice