NCT02573259 · OUTCOME

Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1

A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13

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

Measure: GEOMETRIC_MEAN
Unit: ug/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1

What was measured

Cmax was the maximum concentration after dose administration observed directly from the data.

Analysis population: Analysis population included all enrolled participants treated who were evaluable for this outcome measure.

Groups in this outcome

Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])

Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)

Part 1: PF-06801591 1 mg/kg (IV)

Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)

Part 1: PF-06801591 3 mg/kg (IV)

Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)

Part 1: PF-06801591 10 mg/kg (IV)

Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)

Part 1: PF-06801591 300 mg (Subcutaneously [SC])

Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)

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
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])	2
Part 1: PF-06801591 1 mg/kg (IV)	8
Part 1: PF-06801591 3 mg/kg (IV)	8
Part 1: PF-06801591 10 mg/kg (IV)	7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])	15

Reported measurements

Cycle 1 Day 1

Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])	NA	NA	Not reported	Not reported	Geometric mean and geometric coefficient of variation were not reported for n \< 3.
Part 1: PF-06801591 1 mg/kg (IV)	21.52	23	Not reported	Not reported	Not reported
Part 1: PF-06801591 3 mg/kg (IV)	69.63	28	Not reported	Not reported	Not reported
Part 1: PF-06801591 10 mg/kg (IV)	217.2	36	Not reported	Not reported	Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])	21.24	50	Not reported	Not reported	Not reported

Cycle 4 Day 1

Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])	NA	NA	Not reported	Not reported	Geometric mean and geometric coefficient of variation were not reported for n \< 3.
Part 1: PF-06801591 1 mg/kg (IV)	30.10	16	Not reported	Not reported	Not reported
Part 1: PF-06801591 3 mg/kg (IV)	86.34	52	Not reported	Not reported	Not reported
Part 1: PF-06801591 10 mg/kg (IV)	402.6	42	Not reported	Not reported	Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])	56.48	29	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Geometric mean and geometric coefficient of variation were not reported for n \< 3.
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
23
value
21.52
group Id
OG002
spread
28
value
69.63
group Id
OG003
spread
36
value
217.2
group Id
OG004
spread
50
value
21.24
title
Cycle 1 Day 1
categories
measurements
comment
Geometric mean and geometric coefficient of variation were not reported for n \< 3.
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
16
value
30.10
group Id
OG002
spread
52
value
86.34
group Id
OG003
spread
42
value
402.6
group Id
OG004
spread
29
value
56.48
title
Cycle 4 Day 1

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
8
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
units
Participants

description

Cmax was the maximum concentration after dose administration observed directly from the data.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
id
OG000
title
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
description
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
id
OG001
title
Part 1: PF-06801591 1 mg/kg (IV)
description
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
id
OG002
title
Part 1: PF-06801591 3 mg/kg (IV)
description
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
id
OG003
title
Part 1: PF-06801591 10 mg/kg (IV)
description
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
id
OG004
title
Part 1: PF-06801591 300 mg (Subcutaneously [SC])

param Type

GEOMETRIC_MEAN

population Description

Analysis population included all enrolled participants treated who were evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1

title

Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1

type

SECONDARY

unit Of Measure

ug/mL

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Preserved source evidence · Not medical advice