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NCT01909453 · OUTCOME

Part 2: 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 category at each specified row.

Groups in this outcome

Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)

Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by 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 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)215

Reported measurements

Cycle 1 Day 1: pre-dose

Analysis denominator · Participants

GroupSource count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)215
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)1.6824.3Not reportedNot reportedNot reported
Cycle 1 Day 1: 0.5 hours post dose

Analysis denominator · Participants

GroupSource count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)191
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)366347Not reportedNot reportedNot reported
Cycle 1 Day 1: 1.5 hours post dose

Analysis denominator · Participants

GroupSource count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)196
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)642337Not reportedNot reportedNot reported
Cycle 1 Day 1: 4 to 8 hours post dose

Analysis denominator · Participants

GroupSource count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)169
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)287175Not reportedNot reportedNot reported
Cycle 2 Day 1: pre-dose

Analysis denominator · Participants

GroupSource count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)98
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)72.362.6Not reportedNot reportedNot reported
Cycle 3 Day 1: pre-dose

Analysis denominator · Participants

GroupSource count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)94
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)73.289.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.3
        value
        1.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      units
      Participants
    title
    Cycle 1 Day 1: pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        347
        value
        366
    denoms
    1. counts
      1. group Id
        OG000
        value
        191
      units
      Participants
    title
    Cycle 1 Day 1: 0.5 hours post dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        337
        value
        642
    denoms
    1. counts
      1. group Id
        OG000
        value
        196
      units
      Participants
    title
    Cycle 1 Day 1: 1.5 hours post dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        175
        value
        287
    denoms
    1. counts
      1. group Id
        OG000
        value
        169
      units
      Participants
    title
    Cycle 1 Day 1: 4 to 8 hours post dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.6
        value
        72.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      units
      Participants
    title
    Cycle 2 Day 1: pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        89.0
        value
        73.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      units
      Participants
    title
    Cycle 3 Day 1: pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      215
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG000
    title
    Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
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 category at 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 2: 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