NCT02064387 · OUTCOME

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

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

Measure: GEOMETRIC_MEAN
Unit: Hours*nanogram per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, 30 minutes post start of infusion (SOI), at end of infusion (EOI), 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)

What was measured

Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.

Analysis population: PK Part 1 Population comprised of Part 1 participants of All Treated Population who had atleast 1 non-missing (non-quantifiable, NQ values were considered non-missing) PK assessment. Only those participants with data available at the specified data points were analyzed.

Groups in this outcome

Part 1: GSK2857916 0.03 mg/kg

Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.06 mg/kg

Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.12 mg/kg

Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.24 mg/kg

Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.48 mg/kg

Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.96 mg/kg

Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 1.92 mg/kg

Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 3.40 mg/kg

Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 4.60 mg/kg

Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

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
Part 1: GSK2857916 0.03 mg/kg	0
Part 1: GSK2857916 0.06 mg/kg	1
Part 1: GSK2857916 0.12 mg/kg	4
Part 1: GSK2857916 0.24 mg/kg	3
Part 1: GSK2857916 0.48 mg/kg	3
Part 1: GSK2857916 0.96 mg/kg	2
Part 1: GSK2857916 1.92 mg/kg	1
Part 1: GSK2857916 3.40 mg/kg	0
Part 1: GSK2857916 4.60 mg/kg	4

Reported measurements

Source class 1

Values in Hours*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.06 mg/kg	215803.06	NA	Not reported	Not reported	NA indicates that geometric coefficient of variation could not be calculated for a single participant.
Part 1: GSK2857916 0.12 mg/kg	767285.51	49.51	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	632339.28	101.14	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	2991509.97	72.12	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	9235256.20	46.65	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	18469186.92	NA	Not reported	Not reported	NA indicates that geometric coefficient of variation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	8355209.26	25.29	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
NA indicates that geometric coefficient of variation could not be calculated for a single participant.
group Id
OG001
spread
NA
value
215803.06
group Id
OG002
spread
49.51
value
767285.51
group Id
OG003
spread
101.14
value
632339.28
group Id
OG004
spread
72.12
value
2991509.97
group Id
OG005
spread
46.65
value
9235256.20
comment
NA indicates that geometric coefficient of variation could not be calculated for a single participant.
group Id
OG006
spread
NA
value
18469186.92
group Id
OG008
spread
25.29
value
8355209.26

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
4
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
0
group Id
OG008
value
4
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG000
title
Part 1: GSK2857916 0.03 mg/kg
description
Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG001
title
Part 1: GSK2857916 0.06 mg/kg
description
Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG002
title
Part 1: GSK2857916 0.12 mg/kg
description
Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG003
title
Part 1: GSK2857916 0.24 mg/kg
description
Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG004
title
Part 1: GSK2857916 0.48 mg/kg
description
Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG005
title
Part 1: GSK2857916 0.96 mg/kg
description
Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG006
title
Part 1: GSK2857916 1.92 mg/kg
description
Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG007
title
Part 1: GSK2857916 3.40 mg/kg
description
Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG008
title
Part 1: GSK2857916 4.60 mg/kg

param Type

GEOMETRIC_MEAN

population Description

PK Part 1 Population comprised of Part 1 participants of All Treated Population who had atleast 1 non-missing (non-quantifiable, NQ values were considered non-missing) PK assessment. Only those participants with data available at the specified data points were analyzed.

reporting Status

POSTED

time Frame

Pre-dose, 30 minutes post start of infusion (SOI), at end of infusion (EOI), 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)

title

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1

type

SECONDARY

unit Of Measure

Hours*nanogram per milliliter

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

Preserved source evidence · Not medical advice