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NCT01828099 · OUTCOME

Tmax of LDK378

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days

What was measured

The time to reach peak or maximum concentration (Tmax) was assessed. Actual recorded sampling times were considered for the calculations

Analysis population: The Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one (full or partial) dose of LDK378 and provided at least one evaluable PK blood sample. Only the subset of participants with extensive PK collection were analyzed.

Groups in this outcome

Ceritinib

Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

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

Analysis denominator · Participants

GroupSource count
Ceritinib7

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Ceritinib7
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ceritinib6.00Not reported4.008.00Not reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Ceritinib6
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ceritinib6.00Not reported6.0024.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.00
        upper Limit
        8.00
        value
        6.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.00
        upper Limit
        24.00
        value
        6.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
The time to reach peak or maximum concentration (Tmax) was assessed. Actual recorded sampling times were considered for the calculations
dispersion Type
Full Range
groups
  1. description
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    id
    OG000
    title
    Ceritinib
param Type
MEDIAN
population Description
The Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one (full or partial) dose of LDK378 and provided at least one evaluable PK blood sample. Only the subset of participants with extensive PK collection were analyzed.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days
title
Tmax of LDK378
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice