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NCT02684058 · OUTCOME

Ctrough 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

What was measured

PK parameters were calculated by standard non-compartmental analysis. Ctrough is the pre-dose plasma concentration

Analysis population: Participants who received at least one dose of dabrafenib with an evaluable Ctrough 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 Trametinib38.0162.0Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib46.0125.1Not reportedNot reportedNot reported
Carboxy-dabrafenib
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib398046.1Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib319054.4Not reportedNot reportedNot reported
Desmethyl-dabrafenib
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib275116.5Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib31070.1Not reportedNot reportedNot reported
Hydroxy-dabrafenib
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and Trametinib41.8123.8Not reportedNot reportedNot reported
LGG Cohort: Dabrafenib and Trametinib44.399.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        162.0
        value
        38.0
      2. group Id
        OG001
        spread
        125.1
        value
        46.0
    title
    Dabrafenib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.1
        value
        3980
      2. group Id
        OG001
        spread
        54.4
        value
        3190
    title
    Carboxy-dabrafenib
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        116.5
        value
        275
      2. group Id
        OG001
        spread
        70.1
        value
        310
    title
    Desmethyl-dabrafenib
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        123.8
        value
        41.8
      2. group Id
        OG001
        spread
        99.7
        value
        44.3
    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. Ctrough is the pre-dose plasma concentration
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 Ctrough PK parameter
reporting Status
POSTED
time Frame
Week 3 Day 1 pre-dose
title
Ctrough for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
type
SECONDARY
unit Of Measure
ng/ml

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice