NCT02684058 · OUTCOME

T1/2 for Trametinib

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: hour
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 trametinib 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

Group	Source count
HGG Cohort: Dabrafenib and Trametinib	24
LGG Cohort: Dabrafenib and Trametinib	14

Reported measurements

Source class 1

Values in hour · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
HGG Cohort: Dabrafenib and Trametinib	26.7	62.6	Not reported	Not reported	Not reported
LGG Cohort: Dabrafenib and Trametinib	25.7	37.9	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
62.6
value
26.7
group Id
OG001
spread
37.9
value
25.7

denoms

counts
group Id
OG000
value
24
group Id
OG001
value
14
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

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
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 trametinib 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 Trametinib

type

SECONDARY

unit Of Measure

hour

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

Preserved source evidence · Not medical advice