NCT01829711 · OUTCOME

Systemic Clearance (CL) of Moxetumomab Pasudotox

Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia · Source last updated 2020-04-08

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

Measure: MEAN
Unit: mL/hr/kg
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)

What was measured

The CL of moxetumomab pasudotox is reported.

Analysis population: The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point. Data for Cycle 1 Day 1 was not reported as no evaluable participants for the calculation of the concerned parameters (ie., data were not sufficient).

Groups in this outcome

Moxetumomab Pasudotox 40 µg/kg

Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.

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
Moxetumomab Pasudotox 40 µg/kg	80

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Moxetumomab Pasudotox 40 µg/kg	0

Cycle 1 Day 5

Analysis denominator · Participants

Group	Source count
Moxetumomab Pasudotox 40 µg/kg	49

Values in mL/hr/kg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	44.6	30.5	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Moxetumomab Pasudotox 40 µg/kg	22

Values in mL/hr/kg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	31.8	13.7	Not reported	Not reported	Not reported

Complete source fields

classes

denoms
counts
group Id
OG000
value
0
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
30.5
value
44.6
denoms
counts
group Id
OG000
value
49
units
Participants
title
Cycle 1 Day 5
categories
measurements
group Id
OG000
spread
13.7
value
31.8
denoms
counts
group Id
OG000
value
22
units
Participants
title
Cycle 2 Day 1

denoms

counts
group Id
OG000
value
80
units
Participants

description

The CL of moxetumomab pasudotox is reported.

dispersion Type

Standard Deviation

groups

description
Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
id
OG000
title
Moxetumomab Pasudotox 40 µg/kg

param Type

MEAN

population Description

The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point. Data for Cycle 1 Day 1 was not reported as no evaluable participants for the calculation of the concerned parameters (ie., data were not sufficient).

reporting Status

POSTED

time Frame

Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)

title

Systemic Clearance (CL) of Moxetumomab Pasudotox

type

SECONDARY

unit Of Measure

mL/hr/kg

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice