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NCT01597908 · OUTCOME

Duration of Response (DOR), as Assessed by the Investigator

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma · Source last updated 2021-02-24

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
From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years)

What was measured

Duration of Response (DOR) was defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD was defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data were summarized per RECIST, Version 1.1.

Analysis population: Intent-to-Treat (ITT) Population. Only participants with confirmed response by RECIST version 1.1 were included.

Groups in this outcome

Dabrafenib Plus Trametinib

Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.

Vemurafenib

Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dabrafenib Plus Trametinib237
Vemurafenib185

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dabrafenib Plus Trametinib13.8Not reported11.318.6Not reported
Vemurafenib8.5Not reported7.49.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.51
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.81
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
Complete source fields
analyses
  1. ci Lower Limit
    0.51
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.81
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.3
        upper Limit
        18.6
        value
        13.8
      2. group Id
        OG001
        lower Limit
        7.4
        upper Limit
        9.3
        value
        8.5
denoms
  1. counts
    1. group Id
      OG000
      value
      237
    2. group Id
      OG001
      value
      185
    units
    Participants
description
Duration of Response (DOR) was defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD was defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data were summarized per RECIST, Version 1.1.
dispersion Type
95% Confidence Interval
groups
  1. description
    Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    Dabrafenib Plus Trametinib
  2. description
    Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    OG001
    title
    Vemurafenib
param Type
MEDIAN
population Description
Intent-to-Treat (ITT) Population. Only participants with confirmed response by RECIST version 1.1 were included.
reporting Status
POSTED
time Frame
From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years)
title
Duration of Response (DOR), as Assessed by the Investigator
type
SECONDARY
unit Of Measure
Months

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

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