NCT01871805 · OUTCOME

Number of Participants With Dose Limiting Toxicities (DLTs): Phase I

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2018-08-21

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

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Throughout Cycle 1 of Phase I (21 days)

What was measured

The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (\>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of \>=7 days which the Investigator could not rule out as been related to alectinib.

Analysis population: Phase I safety population

Groups in this outcome

Alectinib 300 mg (Fasted): Phase I

Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

Alectinib 460 mg (Fed): Phase I

Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

Alectinib 600 mg (Fed): Phase I (20/40/150 mg)

Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

Alectinib 760 mg (Fed): Phase I

Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

Alectinib 900 mg (Fed): Phase I (20/40/150 mg)

Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

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 300 mg (Fasted): Phase I	7
Alectinib 460 mg (Fed): Phase I	7
Alectinib 600 mg (Fed): Phase I (20/40/150 mg)	13
Alectinib 760 mg (Fed): Phase I	7
Alectinib 900 mg (Fed): Phase I (20/40/150 mg)	13

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Alectinib 300 mg (Fasted): Phase I	0	Not reported	Not reported	Not reported	Not reported
Alectinib 460 mg (Fed): Phase I	0	Not reported	Not reported	Not reported	Not reported
Alectinib 600 mg (Fed): Phase I (20/40/150 mg)	0	Not reported	Not reported	Not reported	Not reported
Alectinib 760 mg (Fed): Phase I	0	Not reported	Not reported	Not reported	Not reported
Alectinib 900 mg (Fed): Phase I (20/40/150 mg)	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
2

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
7
group Id
OG002
value
13
group Id
OG003
value
7
group Id
OG004
value
13
units
Participants

description

groups

description
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
OG000
title
Alectinib 300 mg (Fasted): Phase I
description
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
OG001
title
Alectinib 460 mg (Fed): Phase I
description
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
OG002
title
Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
description
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
OG003
title
Alectinib 760 mg (Fed): Phase I
description
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
OG004
title
Alectinib 900 mg (Fed): Phase I (20/40/150 mg)

param Type

NUMBER

population Description

Phase I safety population

reporting Status

POSTED

time Frame

Throughout Cycle 1 of Phase I (21 days)

title

Number of Participants With Dose Limiting Toxicities (DLTs): Phase I

type

PRIMARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice