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NCT02684058 · OUTCOME

Cmax 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
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. Cmax is the maximum plasma drug concentration after single dose administration

Analysis population: Participants who received at least one dose of dabrafenib with an evaluable Cmax 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 ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib152065.9Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib133093.5Not reportedNot reportedNot reported
Carboxy-dabrafenib
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib905031.4Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib721051.6Not reportedNot reportedNot reported
Desmethyl-dabrafenib
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib38867.2Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib37767.2Not reportedNot reportedNot reported
Hydroxy-dabrafenib
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib80158.8Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib68782.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.9
        value
        1520
      2. group Id
        OG001
        spread
        93.5
        value
        1330
    title
    Dabrafenib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.4
        value
        9050
      2. group Id
        OG001
        spread
        51.6
        value
        7210
    title
    Carboxy-dabrafenib
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.2
        value
        388
      2. group Id
        OG001
        spread
        67.2
        value
        377
    title
    Desmethyl-dabrafenib
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.8
        value
        801
      2. group Id
        OG001
        spread
        82.6
        value
        687
    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. Cmax is the maximum plasma drug concentration after single dose administration
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 Cmax 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
Cmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
type
SECONDARY
unit Of Measure
ng/ml

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Preserved source evidence · Not medical advice