NCT00586924 · OUTCOME

Systemic Clearance (CL) of Moxetumomab Pasudotox for Cycle 1 on Day 1

A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia · Source last updated 2019-04-02

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

Measure: MEAN
Unit: Milliliter/kilogram/hour (mL/kg/h)
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion

What was measured

Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by area under plasma concentration-time curve from time zero to infinite time (AUC\[0-infinity\]).

Analysis population: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.

Groups in this outcome

5 mcg/kg

Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

10 mcg/kg

Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

20 mcg/kg

Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

30 mcg/kg

Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

40 mcg/kg

Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

50 mcg/kg

Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

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
5 mcg/kg	2
10 mcg/kg	0
20 mcg/kg	1
30 mcg/kg	2
40 mcg/kg	1
50 mcg/kg	8

Reported measurements

Source class 1

Values in Milliliter/kilogram/hour (mL/kg/h) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	32.6	NA	Not reported	Not reported	Standard deviation was reported only when the number of participants analyzed were \>= 3.
20 mcg/kg	49.1	NA	Not reported	Not reported	Standard deviation was reported only when the number of participants analyzed were \>= 3.
30 mcg/kg	43.9	NA	Not reported	Not reported	Standard deviation was reported only when the number of participants analyzed were \>= 3.
40 mcg/kg	91.8	NA	Not reported	Not reported	Standard deviation was reported only when the number of participants analyzed were \>= 3.
50 mcg/kg	106	80.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Standard deviation was reported only when the number of participants analyzed were \>= 3.
group Id
OG000
spread
NA
value
32.6
comment
Standard deviation was reported only when the number of participants analyzed were \>= 3.
group Id
OG002
spread
NA
value
49.1
comment
Standard deviation was reported only when the number of participants analyzed were \>= 3.
group Id
OG003
spread
NA
value
43.9
comment
Standard deviation was reported only when the number of participants analyzed were \>= 3.
group Id
OG004
spread
NA
value
91.8
group Id
OG005
spread
80.2
value
106

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
8
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG000
title
5 mcg/kg
description
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG001
title
10 mcg/kg
description
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG002
title
20 mcg/kg
description
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG003
title
30 mcg/kg
description
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG004
title
40 mcg/kg
description
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG005
title
50 mcg/kg

param Type

MEAN

population Description

The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.

reporting Status

POSTED

time Frame

Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion

title

Systemic Clearance (CL) of Moxetumomab Pasudotox for Cycle 1 on Day 1

type

PRIMARY

unit Of Measure

Milliliter/kilogram/hour (mL/kg/h)

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Preserved source evidence · Not medical advice