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NCT01909453 · OUTCOME

Part 1: Plasma Concentrations of MEK162

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma · Source last updated 2026-02-27

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

Measure
MEAN
Unit
Nanogram per milliliter
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8, hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose

Analysis population: Pharmacokinetic analysis set included all participants who received at least one dose of LGX818 or MEK162 and had at least one evaluable post-baseline LGX818 or MEK162 concentration measurement. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for each specified row.

Groups in this outcome

Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)

Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

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 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)167

Reported measurements

Cycle 1 Day 1: pre-dose

Analysis denominator · Participants

GroupSource count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)167
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)2.9530.7Not reportedNot reportedNot reported
Cycle 1 Day 1: 0.5 hours post dose

Analysis denominator · Participants

GroupSource count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)151
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)426410Not reportedNot reportedNot reported
Cycle 1 Day 1: 1.5 hours post dose

Analysis denominator · Participants

GroupSource count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)117
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)832527Not reportedNot reportedNot reported
Cycle 1 Day 1: 4 to 8 hours post dose

Analysis denominator · Participants

GroupSource count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)138
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)330226Not reportedNot reportedNot reported
Cycle 2 Day 1: pre-dose

Analysis denominator · Participants

GroupSource count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)77
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)81.0106Not reportedNot reportedNot reported
Cycle 3 Day 1: pre-dose

Analysis denominator · Participants

GroupSource count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)65
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)68.1101Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.7
        value
        2.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        167
      units
      Participants
    title
    Cycle 1 Day 1: pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        410
        value
        426
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      units
      Participants
    title
    Cycle 1 Day 1: 0.5 hours post dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        527
        value
        832
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      units
      Participants
    title
    Cycle 1 Day 1: 1.5 hours post dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        226
        value
        330
    denoms
    1. counts
      1. group Id
        OG000
        value
        138
      units
      Participants
    title
    Cycle 1 Day 1: 4 to 8 hours post dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        106
        value
        81.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      units
      Participants
    title
    Cycle 2 Day 1: pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        101
        value
        68.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      units
      Participants
    title
    Cycle 3 Day 1: pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      167
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG000
    title
    Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
param Type
MEAN
population Description
Pharmacokinetic analysis set included all participants who received at least one dose of LGX818 or MEK162 and had at least one evaluable post-baseline LGX818 or MEK162 concentration measurement. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for each specified row.
reporting Status
POSTED
time Frame
Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8, hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
title
Part 1: Plasma Concentrations of MEK162
type
SECONDARY
unit Of Measure
Nanogram per milliliter

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

Preserved source evidence · Not medical advice