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NCT02034110 · OUTCOME

Overall Response Rate (ORR) 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)

What was measured

Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (updated response assessment criteria (CR, PR) WHO Grade 3 and 4 Glioma) by investigator assessment as defined by modified response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.

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 @ up to 78 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Grade (WHO G3/G4) Glioma (HGG)33Not reported20.049.0Not reported
Investigator assessment @ up to 92 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Grade (WHO G3/G4) Glioma (HGG)33Not reported20.049.0Not reported
Independent radiology review @ up to 78 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Grade (WHO G3/G4) Glioma (HGG)31Not reported18.246.6Not reported
Independent radiology review @ up to 92 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Grade (WHO G3/G4) Glioma (HGG)31Not reported18.246.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.0
        upper Limit
        49.0
        value
        33
    title
    Investigator assessment @ up to 78 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.0
        upper Limit
        49.0
        value
        33
    title
    Investigator assessment @ up to 92 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.2
        upper Limit
        46.6
        value
        31
    title
    Independent radiology review @ up to 78 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.2
        upper Limit
        46.6
        value
        31
    title
    Independent radiology review @ up to 92 months
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (updated response assessment criteria (CR, PR) WHO Grade 3 and 4 Glioma) by investigator assessment as defined by modified response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
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
NUMBER
population Description
ITT/Evaluable population - Primary and expansion cohort combined
reporting Status
POSTED
time Frame
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
title
Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
type
PRIMARY
unit Of Measure
Percentage of Participants

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

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