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NCT01266967 · OUTCOME

Progression-free Survival in V600E Mutation-positive Participants

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
weeks
Interval / dispersion
95% Confidence Interval
Time frame
Time from the first dose of study medication to the earliest of death or progression (average of 23 weeks)

What was measured

PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters \[e.g., percent change from Baseline\]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Analysis population: V600E Population

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 Therapy74
GSK2118436 150 mg: Prior Local Therapy65

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy16.1Not reported15.723.4Not reported
GSK2118436 150 mg: Prior Local Therapy16.0Not reported15.923.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.7
        upper Limit
        23.4
        value
        16.1
      2. group Id
        OG001
        lower Limit
        15.9
        upper Limit
        23.9
        value
        16.0
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      65
    units
    Participants
description
PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters \[e.g., percent change from Baseline\]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
dispersion Type
95% Confidence Interval
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
V600E Population
reporting Status
POSTED
time Frame
Time from the first dose of study medication to the earliest of death or progression (average of 23 weeks)
title
Progression-free Survival in V600E Mutation-positive Participants
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice