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NCT02039947 · OUTCOME

Intracranial Response (IR) Rate in Cohort A

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain · Source last updated 2019-05-21

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

Measure
NUMBER
Unit
Number of participants
Interval / dispersion
Not reported
Time frame
From the start of treatment until disease progression or the start of new anti-cancer therapy

What was measured

The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response.

Analysis population: All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population.

Groups in this outcome

Cohort A

Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Cohort A76

Reported measurements

Source class 1
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A45Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    47.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    70.4
    estimate Comment
    Percent
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Response rate
    param Value
    59
    statistical Method
    percent
Complete source fields
analyses
  1. ci Lower Limit
    47.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    70.4
    estimate Comment
    Percent
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Response rate
    param Value
    59
    statistical Method
    percent
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        45
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    units
    Participants
description
The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response.
groups
  1. description
    Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
    id
    OG000
    title
    Cohort A
param Type
NUMBER
population Description
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population.
reporting Status
POSTED
time Frame
From the start of treatment until disease progression or the start of new anti-cancer therapy
title
Intracranial Response (IR) Rate in Cohort A
type
PRIMARY
unit Of Measure
Number of participants

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

Preserved source evidence · Not medical advice