NCT02075840 · OUTCOME

Cmax of Alectinib Metabolite

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants · Source last updated 2026-05-29

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

Measure: GEOMETRIC_MEAN
Unit: nanogram/milliliter (ng/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)

Analysis population: The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.

Groups in this outcome

Alectinib

Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

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
Alectinib	144

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Alectinib	10

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Alectinib	56.2	80.1	Not reported	Not reported	Not reported

Treatment - week 4

Analysis denominator · Participants

Group	Source count
Alectinib	9

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Alectinib	321	32.0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
80.1
value
56.2
denoms
counts
group Id
OG000
value
10
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
32.0
value
321
denoms
counts
group Id
OG000
value
9
units
Participants
title
Treatment - week 4

denoms

counts
group Id
OG000
value
144
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
id
OG000
title
Alectinib

param Type

GEOMETRIC_MEAN

population Description

The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.

reporting Status

POSTED

time Frame

Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)

title

Cmax of Alectinib Metabolite

type

SECONDARY

unit Of Measure

nanogram/milliliter (ng/mL)

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

Preserved source evidence · Not medical advice