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NCT02684058 · OUTCOME

T1/2 for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors · Source last updated 2023-12-13

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

Measure
GEOMETRIC_MEAN
Unit
hr
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose

What was measured

PK parameters were calculated by standard non-compartmental analysis. T1/2 is the elimination half-life

Analysis population: Participants who received at least one dose of dabrafenib with an evaluable T1/2 PK parameter

Groups in this outcome

HGG Cohort: Dabrafenib and Trametinib

Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)

LGG Cohort: Dabrafenib and Trametinib

Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)

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

Analysis denominator · Participants

GroupSource count
HGG Cohort: Dabrafenib and Trametinib33
LGG Cohort: Dabrafenib and Trametinib18

Reported measurements

Dabrafenib

Analysis denominator · Participants

GroupSource count
HGG Cohort: Dabrafenib and Trametinib33
LGG Cohort: Dabrafenib and Trametinib18
Values in hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib2.4836.6Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib3.0936.4Not reportedNot reportedNot reported
Carboxy-dabrafenib

Analysis denominator · Participants

GroupSource count
HGG Cohort: Dabrafenib and Trametinib20
LGG Cohort: Dabrafenib and Trametinib8
Values in hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib7.1232.3Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib6.5943.9Not reportedNot reportedNot reported
Desmethyl-dabrafenib

Analysis denominator · Participants

GroupSource count
HGG Cohort: Dabrafenib and Trametinib3
LGG Cohort: Dabrafenib and Trametinib1
Values in hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib7.06392.5Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib16.1Not reportedNot reportedNot reportedNot reported
Hydroxy-dabrafenib

Analysis denominator · Participants

GroupSource count
HGG Cohort: Dabrafenib and Trametinib20
LGG Cohort: Dabrafenib and Trametinib10
Values in hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib2.6647.8Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib3.5271.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.6
        value
        2.48
      2. group Id
        OG001
        spread
        36.4
        value
        3.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Dabrafenib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.3
        value
        7.12
      2. group Id
        OG001
        spread
        43.9
        value
        6.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Carboxy-dabrafenib
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        392.5
        value
        7.06
      2. group Id
        OG001
        value
        16.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Desmethyl-dabrafenib
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.8
        value
        2.66
      2. group Id
        OG001
        spread
        71.7
        value
        3.52
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Hydroxy-dabrafenib
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      18
    units
    Participants
description
PK parameters were calculated by standard non-compartmental analysis. T1/2 is the elimination half-life
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
    id
    OG000
    title
    HGG Cohort: Dabrafenib and Trametinib
  2. description
    Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
    id
    OG001
    title
    LGG Cohort: Dabrafenib and Trametinib
param Type
GEOMETRIC_MEAN
population Description
Participants who received at least one dose of dabrafenib with an evaluable T1/2 PK parameter
reporting Status
POSTED
time Frame
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
title
T1/2 for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
type
SECONDARY
unit Of Measure
hr

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Preserved source evidence · Not medical advice