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NCT02039947 · OUTCOME

Intracranial Response Rate of Cohorts B, C and D

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
Approximately 2 years

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. No hypothesis testing completed for cohort A, B,C and D

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 B

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

Cohort C

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

Cohort D

Subjects will receive dabrafenib 150 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 B16
Cohort C16
Cohort D17

Reported measurements

Source class 1
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B9Not reportedNot reportedNot reportedNot reported
Cohort C7Not reportedNot reportedNot reportedNot reported
Cohort D10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      17
    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. No hypothesis testing completed for cohort A, B,C and D
groups
  1. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    OG000
    title
    Cohort B
  2. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    OG001
    title
    Cohort C
  3. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    OG002
    title
    Cohort D
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
Approximately 2 years
title
Intracranial Response Rate of Cohorts B, C and D
type
SECONDARY
unit Of Measure
Number of participants

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

Preserved source evidence · Not medical advice