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NCT01072175 · OUTCOME

Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Investigator

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)

What was measured

PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as 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 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment.

Analysis population: ITT Population

Groups in this outcome

Part C: Dabrafenib 150 mg

Participants received dabrafenib 150 mg gelatin capsules BID.

Part C: Dabrafenib 150 mg + Trametinib 1 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.

Part C: Dabrafenib 150 mg + Trametinib 2 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.

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 C: Dabrafenib 150 mg54
Part C: Dabrafenib 150 mg + Trametinib 1 mg54
Part C: Dabrafenib 150 mg + Trametinib 2 mg54

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg5.8Not reported4.37.4Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg9.2Not reported5.711.0Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg9.4Not reported7.616.6Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    estimate Comment
    HRs were estimated using the Pike estimator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0048
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.29
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    estimate Comment
    HRs were estimated using the Pike estimator.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.44
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    estimate Comment
    HRs were estimated using the Pike estimator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0048
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.29
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    estimate Comment
    HRs were estimated using the Pike estimator.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.44
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.3
        upper Limit
        7.4
        value
        5.8
      2. group Id
        OG001
        lower Limit
        5.7
        upper Limit
        11.0
        value
        9.2
      3. group Id
        OG002
        lower Limit
        7.6
        upper Limit
        16.6
        value
        9.4
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      54
    units
    Participants
description
PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as 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 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment.
dispersion Type
Full Range
groups
  1. description
    Participants received dabrafenib 150 mg gelatin capsules BID.
    id
    OG000
    title
    Part C: Dabrafenib 150 mg
  2. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
    id
    OG001
    title
    Part C: Dabrafenib 150 mg + Trametinib 1 mg
  3. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
    id
    OG002
    title
    Part C: Dabrafenib 150 mg + Trametinib 2 mg
param Type
MEDIAN
population Description
ITT Population
reporting Status
POSTED
time Frame
From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)
title
Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Investigator
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Independent clinical review pending · Not medical advice