NCT02257567 · OUTCOME

Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized)

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma · Source last updated 2022-11-14

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

Measure: GEOMETRIC_MEAN
Unit: ng*day/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks

What was measured

Pharmacokinetic (PK) of three pola-related analytes: antibody conjugated monomethyl auristatin E (acMMAE), total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is nanograms\*day per milliliters.

Analysis population: PK population included all ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.

Groups in this outcome

Arm G (Phase II NF Cohort): Pola+BR in DLBCL

Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

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
Arm G (Phase II NF Cohort): Pola+BR in DLBCL	32

Reported measurements

acMMAE

Analysis denominator · Participants

Group	Source count
Arm G (Phase II NF Cohort): Pola+BR in DLBCL	32

Values in ng*day/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Arm G (Phase II NF Cohort): Pola+BR in DLBCL	2880	0.15	Not reported	Not reported	Not reported

Total Antibody (Ab)

Analysis denominator · Participants

Group	Source count
Arm G (Phase II NF Cohort): Pola+BR in DLBCL	0

MMAE

Analysis denominator · Participants

Group	Source count
Arm G (Phase II NF Cohort): Pola+BR in DLBCL	32

Values in ng*day/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Arm G (Phase II NF Cohort): Pola+BR in DLBCL	21.6	45	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.15
value
2880
denoms
counts
group Id
OG000
value
32
units
Participants
title
acMMAE
denoms
counts
group Id
OG000
value
0
units
Participants
title
Total Antibody (Ab)
categories
measurements
group Id
OG000
spread
45
value
21.6
denoms
counts
group Id
OG000
value
32
units
Participants
title
MMAE

denoms

counts
group Id
OG000
value
32
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
id
OG000
title
Arm G (Phase II NF Cohort): Pola+BR in DLBCL

param Type

GEOMETRIC_MEAN

population Description

PK population included all ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.

reporting Status

POSTED

time Frame

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks

title

Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized)

type

PRIMARY

unit Of Measure

ng*day/mL

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Preserved source evidence · Not medical advice