Skip to content
TriangleGet started
← Full study record

NCT02034110 · OUTCOME

Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) 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 (response assessment criteria (CR, PR, and minor response \[MR\]) WHO Grade 1 and 2 Glioma) by investigator assessment as defined by 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 analysis cohort

Groups in this outcome

Low Grade (WHO G1/G2) Glioma (LGG)

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
Low Grade (WHO G1/G2) Glioma (LGG)13

Reported measurements

Investigator assessment/Response rate @ up to 78 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low Grade (WHO G1/G2) Glioma (LGG)69Not reported38.690.9Not reported
Investigator assessment/Response rate @ up to 92 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low Grade (WHO G1/G2) Glioma (LGG)69Not reported38.690.9Not reported
Independent radiology review/Response rate @ up to 78 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low Grade (WHO G1/G2) Glioma (LGG)69Not reported38.690.9Not reported
Independent radiology review/Response rate @ up to 92 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low Grade (WHO G1/G2) Glioma (LGG)62Not reported31.686.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.6
        upper Limit
        90.9
        value
        69
    title
    Investigator assessment/Response rate @ up to 78 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.6
        upper Limit
        90.9
        value
        69
    title
    Investigator assessment/Response rate @ up to 92 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.6
        upper Limit
        90.9
        value
        69
    title
    Independent radiology review/Response rate @ up to 78 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.6
        upper Limit
        86.1
        value
        62
    title
    Independent radiology review/Response rate @ up to 92 months
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (response assessment criteria (CR, PR, and minor response \[MR\]) WHO Grade 1 and 2 Glioma) by investigator assessment as defined by 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
    Low Grade (WHO G1/G2) Glioma (LGG)
param Type
NUMBER
population Description
ITT/Evaluable population - Primary analysis cohort
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 Low Grade (WHO G1/G2) Glioma (LGG) 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