NCT02713529 · OUTCOME

AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2

Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer · Source last updated 2023-01-20

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

Measure: GEOMETRIC_MEAN
Unit: hr*ug/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36

What was measured

AUCtau is the area under the serum concentration-time curve over the dose interval tau, with tau equal to 21 days.

Analysis population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.

Groups in this outcome

AMG 820 1100 mg

Includes participants from all treatment arms that were administered AMG 820 1100 mg.

AMG 820 1400 mg

Includes participants from all treatment arms who were administered AMG 820 1400 mg

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
AMG 820 1100 mg	97
AMG 820 1400 mg	18

Reported measurements

Cycle 1

Analysis denominator · Participants

Group	Source count
AMG 820 1100 mg	97
AMG 820 1400 mg	18

Values in hr*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
AMG 820 1100 mg	59300	33	Not reported	Not reported	Not reported
AMG 820 1400 mg	90000	29	Not reported	Not reported	Not reported

Cycle 2

Analysis denominator · Participants

Group	Source count
AMG 820 1100 mg	68
AMG 820 1400 mg	9

Values in hr*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
AMG 820 1100 mg	75400	35	Not reported	Not reported	Not reported
AMG 820 1400 mg	114000	31	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
33
value
59300
group Id
OG001
spread
29
value
90000
denoms
counts
group Id
OG000
value
97
group Id
OG001
value
18
units
Participants
title
Cycle 1
categories
measurements
group Id
OG000
spread
35
value
75400
group Id
OG001
spread
31
value
114000
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
9
units
Participants
title
Cycle 2

denoms

counts
group Id
OG000
value
97
group Id
OG001
value
18
units
Participants

description

AUCtau is the area under the serum concentration-time curve over the dose interval tau, with tau equal to 21 days.

dispersion Type

Geometric Coefficient of Variation

groups

description
Includes participants from all treatment arms that were administered AMG 820 1100 mg.
id
OG000
title
AMG 820 1100 mg
description
Includes participants from all treatment arms who were administered AMG 820 1400 mg
id
OG001
title
AMG 820 1400 mg

param Type

GEOMETRIC_MEAN

population Description

Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.

reporting Status

POSTED

time Frame

Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36

title

AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2

type

SECONDARY

unit Of Measure

hr*ug/mL

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

Preserved source evidence · Not medical advice