NCT01970865 · OUTCOME

Terminal Half-Life of PF-06463922 Following Single Oral Doses (Phase 1)

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12

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

Measure: MEAN
Unit: Hours (hr)
Interval / dispersion: Standard Deviation
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.

What was measured

Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase.

Analysis population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Groups in this outcome

10 mg QD (Phase 1)

PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

50 mg QD (Phase 1)

PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

75 mg QD (Phase 1)

PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

100 mg QD (Phase 1)

PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

200 mg QD (Phase 1)

PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

35 mg BID (Phase 1)

PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

75 mg BID (Phase 1)

PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

100 mg BID (Phase 1)

PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

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
10 mg QD (Phase 1)	1
50 mg QD (Phase 1)	2
75 mg QD (Phase 1)	11
100 mg QD (Phase 1)	15
200 mg QD (Phase 1)	3
35 mg BID (Phase 1)	2
75 mg BID (Phase 1)	1
100 mg BID (Phase 1)	4

Reported measurements

Source class 1

Values in Hours (hr) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
10 mg QD (Phase 1)	NA	NA	Not reported	Not reported	Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 18.0 hr.
50 mg QD (Phase 1)	23.70	NA	Not reported	Not reported	Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 16.6 and 30.8 hr, respectively.
75 mg QD (Phase 1)	27.22	8.2961	Not reported	Not reported	Not reported
100 mg QD (Phase 1)	20.89	5.0308	Not reported	Not reported	Not reported
200 mg QD (Phase 1)	19.80	3.3045	Not reported	Not reported	Not reported
35 mg BID (Phase 1)	25.55	NA	Not reported	Not reported	Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 24.6 and 26.5 hr, respectively.
75 mg BID (Phase 1)	NA	NA	Not reported	Not reported	Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 26.0 hr.
100 mg BID (Phase 1)	17.18	5.1874	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 18.0 hr.
group Id
OG000
spread
NA
value
NA
comment
Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 16.6 and 30.8 hr, respectively.
group Id
OG001
spread
NA
value
23.70
group Id
OG002
spread
8.2961
value
27.22
group Id
OG003
spread
5.0308
value
20.89
group Id
OG004
spread
3.3045
value
19.80
comment
Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 24.6 and 26.5 hr, respectively.
group Id
OG005
spread
NA
value
25.55
comment
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 26.0 hr.
group Id
OG006
spread
NA
value
NA
group Id
OG007
spread
5.1874
value
17.18

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
11
group Id
OG003
value
15
group Id
OG004
value
3
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
4
units
Participants

description

Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase.

dispersion Type

Standard Deviation

groups

description
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG000
title
10 mg QD (Phase 1)
description
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG001
title
50 mg QD (Phase 1)
description
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG002
title
75 mg QD (Phase 1)
description
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG003
title
100 mg QD (Phase 1)
description
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG004
title
200 mg QD (Phase 1)
description
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG005
title
35 mg BID (Phase 1)
description
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG006
title
75 mg BID (Phase 1)
description
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG007
title
100 mg BID (Phase 1)

param Type

MEAN

population Description

PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.

title

Terminal Half-Life of PF-06463922 Following Single Oral Doses (Phase 1)

type

SECONDARY

unit Of Measure

Hours (hr)

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Preserved source evidence · Not medical advice