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NCT02684058 · OUTCOME

AUClast 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 * ng/ml
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. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast).

Analysis population: Participants who received at least one dose of dabrafenib with an evaluable AUClast 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 * ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib433044.7Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib487060.3Not reportedNot reportedNot reported
Carboxy-dabrafenib
Values in hr * ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib7340031.5Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib6420046.9Not reportedNot reportedNot reported
Desmethyl-dabrafenib
Values in hr * ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib352060.2Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib387068.2Not reportedNot reportedNot reported
Hydroxy-dabrafenib
Values in hr * ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib281036.5Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib298050.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.7
        value
        4330
      2. group Id
        OG001
        spread
        60.3
        value
        4870
    title
    Dabrafenib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.5
        value
        73400
      2. group Id
        OG001
        spread
        46.9
        value
        64200
    title
    Carboxy-dabrafenib
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.2
        value
        3520
      2. group Id
        OG001
        spread
        68.2
        value
        3870
    title
    Desmethyl-dabrafenib
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.5
        value
        2810
      2. group Id
        OG001
        spread
        50.1
        value
        2980
    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. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast).
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 AUClast 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
AUClast for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
type
SECONDARY
unit Of Measure
hr * ng/ml

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Preserved source evidence · Not medical advice