NCT01536145 · OUTCOME

Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871

CP-751,871 Treatment For Patients With Multiple Myeloma · Source last updated 2013-03-15

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

Measure: MEAN
Unit: mL/kg
Interval / dispersion: Standard Deviation
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

Analysis population: All participants treated who had at least 1 of the PK parameters of primary interest.

Groups in this outcome

CP-751,871 0.2 mg/kg

CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 0.4 mg/kg

CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 0.8 mg/kg

CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 1.5 mg/kg

CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 3 mg/kg

CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)

CP-751,871 6 mg/kg

CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 10 mg/kg

CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

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
CP-751,871 0.2 mg/kg	3
CP-751,871 0.4 mg/kg	4
CP-751,871 0.8 mg/kg	3
CP-751,871 1.5 mg/kg	2
CP-751,871 3 mg/kg	3
CP-751,871 6 mg/kg	3
CP-751,871 10 mg/kg	5

Reported measurements

Source class 1

Values in mL/kg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
CP-751,871 0.2 mg/kg	46.0	11.9	Not reported	Not reported	Not reported
CP-751,871 0.4 mg/kg	65.9	24.7	Not reported	Not reported	Not reported
CP-751,871 0.8 mg/kg	72.6	21.1	Not reported	Not reported	Not reported
CP-751,871 1.5 mg/kg	50.9	NA	Not reported	Not reported	Number of participants analyzed was less than 3, thus standard deviation was not calculated.
CP-751,871 3 mg/kg	81.4	16.6	Not reported	Not reported	Not reported
CP-751,871 6 mg/kg	69.4	16.0	Not reported	Not reported	Not reported
CP-751,871 10 mg/kg	92.1	15.8	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
11.9
value
46.0
group Id
OG001
spread
24.7
value
65.9
group Id
OG002
spread
21.1
value
72.6
comment
Number of participants analyzed was less than 3, thus standard deviation was not calculated.
group Id
OG003
spread
NA
value
50.9
group Id
OG004
spread
16.6
value
81.4
group Id
OG005
spread
16.0
value
69.4
group Id
OG006
spread
15.8
value
92.1

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
5
units
Participants

dispersion Type

Standard Deviation

groups

description
CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
id
OG000
title
CP-751,871 0.2 mg/kg
description
CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
id
OG001
title
CP-751,871 0.4 mg/kg
description
CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
id
OG002
title
CP-751,871 0.8 mg/kg
description
CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
id
OG003
title
CP-751,871 1.5 mg/kg
description
CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
id
OG004
title
CP-751,871 3 mg/kg
description
CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
id
OG005
title
CP-751,871 6 mg/kg
description
CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
id
OG006
title
CP-751,871 10 mg/kg

param Type

MEAN

population Description

All participants treated who had at least 1 of the PK parameters of primary interest.

reporting Status

POSTED

time Frame

Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

title

Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871

type

SECONDARY

unit Of Measure

mL/kg

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Preserved source evidence · Not medical advice