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NCT01909453 · OUTCOME

Part 2: Plasma Concentrations of LGX 818

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" =number of participants evaluable for this outcome measure and "Number analyzed" =participants evaluable at each specified row. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.

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.

Part 2: LGX818 300 mg

Participants received 300 mg of LGX818 orally once 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.

Part 1 + Part 2: LGX818 300 mg

Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and 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)242
Part 2: LGX818 300 mg80
Part 1 + Part 2: LGX818 300 mg252

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)242
Part 2: LGX818 300 mg80
Part 1 + Part 2: LGX818 300 mg252
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)5.0277.8Not reportedNot reportedNot reported
Part 2: LGX818 300 mg0.01450.130Not reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg39.7424Not 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)207
Part 2: LGX818 300 mg68
Part 1 + Part 2: LGX818 300 mg213
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)13602000Not reportedNot reportedNot reported
Part 2: LGX818 300 mg13702170Not reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg12501910Not 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)220
Part 2: LGX818 300 mg73
Part 1 + Part 2: LGX818 300 mg189
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)43902380Not reportedNot reportedNot reported
Part 2: LGX818 300 mg43102570Not reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg41702290Not 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)185
Part 2: LGX818 300 mg66
Part 1 + Part 2: LGX818 300 mg208
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)24201270Not reportedNot reportedNot reported
Part 2: LGX818 300 mg22501170Not reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg19801020Not 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)175
Part 2: LGX818 300 mg32
Part 1 + Part 2: LGX818 300 mg105
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)121483Not reportedNot reportedNot reported
Part 2: LGX818 300 mg29.599.9Not reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg60.1342Not 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)151
Part 2: LGX818 300 mg27
Part 1 + Part 2: LGX818 300 mg101
Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)74.1322Not reportedNot reportedNot reported
Part 2: LGX818 300 mg79.5291Not reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg60.6265Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        77.8
        value
        5.02
      2. group Id
        OG001
        spread
        0.130
        value
        0.0145
      3. group Id
        OG002
        spread
        424
        value
        39.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        242
      2. group Id
        OG001
        value
        80
      3. group Id
        OG002
        value
        252
      units
      Participants
    title
    Cycle 1 Day 1: pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2000
        value
        1360
      2. group Id
        OG001
        spread
        2170
        value
        1370
      3. group Id
        OG002
        spread
        1910
        value
        1250
    denoms
    1. counts
      1. group Id
        OG000
        value
        207
      2. group Id
        OG001
        value
        68
      3. group Id
        OG002
        value
        213
      units
      Participants
    title
    Cycle 1 Day 1: 0.5 hours post dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2380
        value
        4390
      2. group Id
        OG001
        spread
        2570
        value
        4310
      3. group Id
        OG002
        spread
        2290
        value
        4170
    denoms
    1. counts
      1. group Id
        OG000
        value
        220
      2. group Id
        OG001
        value
        73
      3. group Id
        OG002
        value
        189
      units
      Participants
    title
    Cycle 1 Day 1: 1.5 hours post dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1270
        value
        2420
      2. group Id
        OG001
        spread
        1170
        value
        2250
      3. group Id
        OG002
        spread
        1020
        value
        1980
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      2. group Id
        OG001
        value
        66
      3. group Id
        OG002
        value
        208
      units
      Participants
    title
    Cycle 1 Day 1: 4 to 8 hours post dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        483
        value
        121
      2. group Id
        OG001
        spread
        99.9
        value
        29.5
      3. group Id
        OG002
        spread
        342
        value
        60.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        175
      2. group Id
        OG001
        value
        32
      3. group Id
        OG002
        value
        105
      units
      Participants
    title
    Cycle 2 Day 1: pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        322
        value
        74.1
      2. group Id
        OG001
        spread
        291
        value
        79.5
      3. group Id
        OG002
        spread
        265
        value
        60.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      2. group Id
        OG001
        value
        27
      3. group Id
        OG002
        value
        101
      units
      Participants
    title
    Cycle 3 Day 1: pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      242
    2. group Id
      OG001
      value
      80
    3. group Id
      OG002
      value
      252
    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)
  2. description
    Participants received 300 mg of LGX818 orally once 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
    OG001
    title
    Part 2: LGX818 300 mg
  3. description
    Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.
    id
    OG002
    title
    Part 1 + Part 2: LGX818 300 mg
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" =number of participants evaluable for this outcome measure and "Number analyzed" =participants evaluable at each specified row. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
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 LGX 818
type
SECONDARY
unit Of Measure
Nanogram per milliliter

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

Preserved source evidence · Not medical advice