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NCT02034110 · OUTCOME

Progression Free Survival (PFS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers · Source last updated 2023-08-21

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
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)

What was measured

Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.

Analysis population: ITT/Evaluable population - Primary and expansion cohort combined

Groups in this outcome

High Grade (WHO G3/G4) Glioma (HGG)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

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

Analysis denominator · Participants

GroupSource count
High Grade (WHO G3/G4) Glioma (HGG)45

Reported measurements

Investigator assessment
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Grade (WHO G3/G4) Glioma (HGG)24.0Not reported8.059.4Not reported
Independent radiology review
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Grade (WHO G3/G4) Glioma (HGG)19.7Not reported8.032.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.0
        upper Limit
        59.4
        value
        24.0
    title
    Investigator assessment
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.0
        upper Limit
        32.1
        value
        19.7
    title
    Independent radiology review
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG000
    title
    High Grade (WHO G3/G4) Glioma (HGG)
param Type
MEDIAN
population Description
ITT/Evaluable population - Primary and expansion cohort combined
reporting Status
POSTED
time Frame
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
title
Progression Free Survival (PFS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
type
SECONDARY
unit Of Measure
Weeks

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

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