NCT01950364 · OUTCOME

Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma · Source last updated 2016-05-11

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

Measure: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 3: 480 hour postdose

What was measured

Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

Analysis population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.

Groups in this outcome

Brentuximab Vedotin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.

Brentuximab Vedotin + Rifampicin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.

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
Brentuximab Vedotin	9
Brentuximab Vedotin + Rifampicin	9

Reported measurements

MMAE

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin	0.1189	0.15808	Not reported	Not reported	Not reported
Brentuximab Vedotin + Rifampicin	0.0941	0.03974	Not reported	Not reported	Not reported

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Brentuximab Vedotin + Rifampicin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Brentuximab Vedotin + Rifampicin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Brentuximab Vedotin + Rifampicin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin	0.0114	0.00431	Not reported	Not reported	Not reported
Brentuximab Vedotin + Rifampicin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.

C13

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Brentuximab Vedotin + Rifampicin	NA	NA	Not reported	Not reported	None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.15808
value
0.1189
group Id
OG001
spread
0.03974
value
0.0941
title
MMAE
categories
measurements
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG000
spread
NA
value
NA
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG001
spread
NA
value
NA
title
C4
categories
measurements
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG000
spread
NA
value
NA
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG001
spread
NA
value
NA
title
C5
categories
measurements
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG000
spread
NA
value
NA
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG001
spread
NA
value
NA
title
C7
categories
measurements
group Id
OG000
spread
0.00431
value
0.0114
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG001
spread
NA
value
NA
title
C8
categories
measurements
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG000
spread
NA
value
NA
comment
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
group Id
OG001
spread
NA
value
NA
title
C13

denoms

counts
group Id
OG000
value
9
group Id
OG001
value
9
units
Participants

description

Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

dispersion Type

Standard Deviation

groups

description
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
id
OG000
title
Brentuximab Vedotin
description
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
id
OG001
title
Brentuximab Vedotin + Rifampicin

param Type

GEOMETRIC_MEAN

population Description

PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.

reporting Status

POSTED

time Frame

Cycle 3: 480 hour postdose

title

Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose

type

PRIMARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice