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NCT01909453 · OUTCOME

Part 1 and Part 2: Time to Definitive 10% Deterioration in the Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Date of randomization to date of event or death due to any cause, which ever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)

What was measured

FACT-M:melanoma specific questionnaire to assess participant health-related quality of life(QoL).Melanoma specific 16 subscale :signs,symptoms,physical/social activities most relevant to participants with advanced-stage melanoma.Other items :physical,functional and social/family well-being(7 items each),emotional well-being(6 items),surgery specific concerns related to melanoma(8 items,not included in this study).Each item range 0(not at all)to 4(very much),combined to produce subscale scores.Total score range for FACT-M excluding surgery specific items is 0 to172,higher scores:better QoL.Melanoma subscale score range from0(worst)to 64(best response),higher score:better QoL.Time to definitive 10% deterioration:time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause.All collected data up to pre-specified collection period(i.e.,end of study)are reported for this OM.

Analysis population: FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.

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.

Part 1: 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: Vemurafenib 960 mg BID

Participants received 960 mg of Vemurafenib according to the locally approved prescribing information 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 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 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)192
Part 1: LGX818 300 mg194
Part 1: Vemurafenib 960 mg BID191
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)258
Part 2: LGX818 300 mg86
Part 1 + Part 2: LGX818 300 mg280

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)NANot reported22.1NAMedian and upper limit of 95% CI were not estimable due to low number of participants with events.
Part 1: LGX818 300 mg30.5Not reported18.430.5Not reported
Part 1: Vemurafenib 960 mg BID22.1Not reported15.2NAUpper limit of 95% CI was not estimable due to low number of participants with events.
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)NANot reportedNANAMedian and 95% CI were not estimable due to low number of participants with events.
Part 2: LGX818 300 mgNANot reported9.4NAMedian and upper limit of 95% CI were not estimable due to low number of participants with events.
Part 1 + Part 2: LGX818 300 mg20.5Not reported16.630.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of 95% CI were not estimable due to low number of participants with events.
        group Id
        OG000
        lower Limit
        22.1
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        18.4
        upper Limit
        30.5
        value
        30.5
      3. comment
        Upper limit of 95% CI was not estimable due to low number of participants with events.
        group Id
        OG002
        lower Limit
        15.2
        upper Limit
        NA
        value
        22.1
      4. comment
        Median and 95% CI were not estimable due to low number of participants with events.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        Median and upper limit of 95% CI were not estimable due to low number of participants with events.
        group Id
        OG004
        lower Limit
        9.4
        upper Limit
        NA
        value
        NA
      6. group Id
        OG005
        lower Limit
        16.6
        upper Limit
        30.5
        value
        20.5
denoms
  1. counts
    1. group Id
      OG000
      value
      192
    2. group Id
      OG001
      value
      194
    3. group Id
      OG002
      value
      191
    4. group Id
      OG003
      value
      258
    5. group Id
      OG004
      value
      86
    6. group Id
      OG005
      value
      280
    units
    Participants
description
FACT-M:melanoma specific questionnaire to assess participant health-related quality of life(QoL).Melanoma specific 16 subscale :signs,symptoms,physical/social activities most relevant to participants with advanced-stage melanoma.Other items :physical,functional and social/family well-being(7 items each),emotional well-being(6 items),surgery specific concerns related to melanoma(8 items,not included in this study).Each item range 0(not at all)to 4(very much),combined to produce subscale scores.Total score range for FACT-M excluding surgery specific items is 0 to172,higher scores:better QoL.Melanoma subscale score range from0(worst)to 64(best response),higher score:better QoL.Time to definitive 10% deterioration:time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause.All collected data up to pre-specified collection period(i.e.,end of study)are reported for this OM.
dispersion Type
95% Confidence Interval
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)
  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 1: LGX818 300 mg
  3. description
    Participants received 960 mg of Vemurafenib according to the locally approved prescribing information 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
    OG002
    title
    Part 1: Vemurafenib 960 mg BID
  4. 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
    OG003
    title
    Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
  5. 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
    OG004
    title
    Part 2: LGX818 300 mg
  6. 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
    OG005
    title
    Part 1 + Part 2: LGX818 300 mg
param Type
MEDIAN
population Description
FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
reporting Status
POSTED
time Frame
Date of randomization to date of event or death due to any cause, which ever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
title
Part 1 and Part 2: Time to Definitive 10% Deterioration in the Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale
type
SECONDARY
unit Of Measure
Months

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