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NCT01742286 · OUTCOME

PK Parameter: Tmax in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) · Source last updated 2020-06-09

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

Measure
MEDIAN
Unit
hour (hr)
Interval / dispersion
Full Range
Time frame
0hr pre-dose, 2, 4, 6 & 24hrs post-dose

What was measured

Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1. Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration

Analysis population: The PK analysis set (PAS), MTD/RDE consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Groups in this outcome

Fasted: Ceritinib 510 mg/m2

Participants in the fasted group who took 510 mg of ceritinib

Fed: Ceritinib 500 mg/m2

Participants in the fed group who took 500 mg of ceritinib

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

Analysis denominator · Participants

GroupSource count
Fasted: Ceritinib 510 mg/m24
Fed: Ceritinib 500 mg/m214

Reported measurements

Source class 1
Values in hour (hr) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 510 mg/m26.20Not reported3.8023.8Not reported
Fed: Ceritinib 500 mg/m25.90Not reported1.9023.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.80
        upper Limit
        23.8
        value
        6.20
      2. group Id
        OG001
        lower Limit
        1.90
        upper Limit
        23.6
        value
        5.90
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1. Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration
dispersion Type
Full Range
groups
  1. description
    Participants in the fasted group who took 510 mg of ceritinib
    id
    OG000
    title
    Fasted: Ceritinib 510 mg/m2
  2. description
    Participants in the fed group who took 500 mg of ceritinib
    id
    OG001
    title
    Fed: Ceritinib 500 mg/m2
param Type
MEDIAN
population Description
The PK analysis set (PAS), MTD/RDE consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
reporting Status
POSTED
time Frame
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
title
PK Parameter: Tmax in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
type
SECONDARY
unit Of Measure
hour (hr)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice