NCT01828099 · OUTCOME

Cmax 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: GEOMETRIC_MEAN
Unit: nanogram (ng) / mililiter (ml)
Interval / dispersion: Geometric Coefficient of Variation
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 observed maximum plasma concentration following administration

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 pharmacokinetic (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

Group	Source count
Ceritinib	7

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Ceritinib	7

Values in nanogram (ng) / mililiter (ml) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	162	106.9	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Ceritinib	6

Values in nanogram (ng) / mililiter (ml) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	794	39.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
106.9
value
162
denoms
counts
group Id
OG000
value
7
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
39.2
value
794
denoms
counts
group Id
OG000
value
6
units
Participants
title
Cycle 2 Day 1

denoms

counts
group Id
OG000
value
7
units
Participants

description

The observed maximum plasma concentration following administration

dispersion Type

Geometric Coefficient of Variation

groups

description
Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
id
OG000
title
Ceritinib

param Type

GEOMETRIC_MEAN

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 pharmacokinetic (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

Cmax of LDK378

type

SECONDARY

unit Of Measure

nanogram (ng) / mililiter (ml)

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

Preserved source evidence · Not medical advice