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NCT02124772 · OUTCOME

Apparent Clearance (CL/F) of Trametinib Estimated With a PopPK Model

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations · Source last updated 2021-07-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
liters/hour
Interval / dispersion
Not reported
Time frame
pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

What was measured

The population pharmacokinetic (PopPK) model of trametinib can be described using a two-compartment model with dual sequential 1st order absorption (Ka1, Ka2) and 1st order elimination. Apparent clearance (CL/F) of trametinib estimated with the PopPK model is summarized in this record.

Analysis population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.

Groups in this outcome

Part A, B, C and D - All Participants With PK Data

Participants in the study (all doses and all tumor types) with available pharmacokinetic data

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A, B, C and D - All Participants With PK Data133

Reported measurements

Source class 1
Values in liters/hour · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A, B, C and D - All Participants With PK Data5.07Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5.07
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    units
    Participants
description
The population pharmacokinetic (PopPK) model of trametinib can be described using a two-compartment model with dual sequential 1st order absorption (Ka1, Ka2) and 1st order elimination. Apparent clearance (CL/F) of trametinib estimated with the PopPK model is summarized in this record.
groups
  1. description
    Participants in the study (all doses and all tumor types) with available pharmacokinetic data
    id
    OG000
    title
    Part A, B, C and D - All Participants With PK Data
param Type
NUMBER
population Description
All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.
reporting Status
POSTED
time Frame
pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.
title
Apparent Clearance (CL/F) of Trametinib Estimated With a PopPK Model
type
SECONDARY
unit Of Measure
liters/hour

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

Preserved source evidence · Independent clinical review pending · Not medical advice