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NCT02684058 · OUTCOME

Tmax 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. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations.

Analysis population: Participants who received at least one dose of dabrafenib with an evaluable Tmax 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 Trametinib34
LGG Cohort: Dabrafenib and Trametinib54

Reported measurements

Dabrafenib
Values in hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib1.4754.2Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib1.4752.9Not reportedNot reportedNot reported
Carboxy-dabrafenib
Values in hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib3.3735.4Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib3.6651.4Not reportedNot reportedNot reported
Desmethyl-dabrafenib
Values in hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib2.2176.7Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib2.2982.0Not reportedNot reportedNot reported
Hydroxy-dabrafenib
Values in hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib1.9745.9Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib1.6857.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.2
        value
        1.47
      2. group Id
        OG001
        spread
        52.9
        value
        1.47
    title
    Dabrafenib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.4
        value
        3.37
      2. group Id
        OG001
        spread
        51.4
        value
        3.66
    title
    Carboxy-dabrafenib
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.7
        value
        2.21
      2. group Id
        OG001
        spread
        82.0
        value
        2.29
    title
    Desmethyl-dabrafenib
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.9
        value
        1.97
      2. group Id
        OG001
        spread
        57.8
        value
        1.68
    title
    Hydroxy-dabrafenib
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      54
    units
    Participants
description
PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations.
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 Tmax 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
Tmax 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