NCT02684058 · OUTCOME

AUClast 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 (hr) * nanogram (ng)/mililiter (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

Pharmacokinetic (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 trametinib 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

Group	Source count
HGG Cohort: Dabrafenib and Trametinib	36
LGG Cohort: Dabrafenib and Trametinib	55

Reported measurements

Source class 1

Values in hour (hr) * nanogram (ng)/mililiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
HGG Cohort: Dabrafenib and Trametinib	282	53.7	Not reported	Not reported	Not reported
LGG Cohort: Dabrafenib and Trametinib	328	33.4	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
53.7
value
282
group Id
OG001
spread
33.4
value
328

denoms

counts
group Id
OG000
value
36
group Id
OG001
value
55
units
Participants

description

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 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 Trametinib

type

SECONDARY

unit Of Measure

hour (hr) * nanogram (ng)/mililiter (mL)

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

Preserved source evidence · Not medical advice