NCT02064387 · OUTCOME

Ctrough of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg

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: Nanograms per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)

What was measured

Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.

Analysis population: PK Part 1 Population.Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Part 1: GSK2857916 2.50 mg/kg

Participants were administered a dose of 2.50 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 2.50 mg/kg	8

Reported measurements

Day 1, Cycle 1,n=8

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 2.50 mg/kg	8

Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 2.50 mg/kg	3726.78	49.92	Not reported	Not reported	Not reported

Day 1, Cycle 2,n=4

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 2.50 mg/kg	4

Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 2.50 mg/kg	11352.94	268.64	Not reported	Not reported	Not reported

Day 1, Cycle 4,n=3

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 2.50 mg/kg	3

Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 2.50 mg/kg	11121.73	59.75	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
49.92
value
3726.78
denoms
counts
group Id
OG000
value
8
units
Participants
title
Day 1, Cycle 1,n=8
categories
measurements
group Id
OG000
spread
268.64
value
11352.94
denoms
counts
group Id
OG000
value
4
units
Participants
title
Day 1, Cycle 2,n=4
categories
measurements
group Id
OG000
spread
59.75
value
11121.73
denoms
counts
group Id
OG000
value
3
units
Participants
title
Day 1, Cycle 4,n=3

denoms

counts
group Id
OG000
value
8
units
Participants

description

Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG000
title
Part 1: GSK2857916 2.50 mg/kg

param Type

GEOMETRIC_MEAN

population Description

PK Part 1 Population.Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

reporting Status

POSTED

time Frame

Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)

title

Ctrough of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg

type

SECONDARY

unit Of Measure

Nanograms per milliliter

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

Preserved source evidence · Not medical advice