NCT01943851 · OUTCOME

Part 2: Plasma Concentrations of GSK525762 in Relationship With Safety and Efficacy Parameters Derived From Pharmacokinetic/Pharmacodynamic (PK/PD) Model

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies · Source last updated 2024-10-01

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

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Up to 36.4 weeks

What was measured

Plasma concentrations of GSK525762 in relationship with safety and efficacy parameters derived from PK/PD model was planned to be analyzed.

Analysis population: PK Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.

Groups in this outcome

Part 2: GSK525762 60 mg QD CTCL

Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.

Part 2: GSK525762 75 mg QD MDS

Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762

Part 2: GSK525762 80 mg QD CTCL

Participants CTCL were administered once daily oral dose of 80 mg GSK525762

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 2: GSK525762 60 mg QD CTCL	0
Part 2: GSK525762 75 mg QD MDS	0
Part 2: GSK525762 80 mg QD CTCL	0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
units
Participants

description

Plasma concentrations of GSK525762 in relationship with safety and efficacy parameters derived from PK/PD model was planned to be analyzed.

groups

description
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
id
OG000
title
Part 2: GSK525762 60 mg QD CTCL
description
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
id
OG001
title
Part 2: GSK525762 75 mg QD MDS
description
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
id
OG002
title
Part 2: GSK525762 80 mg QD CTCL

population Description

PK Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.

reporting Status

POSTED

time Frame

Up to 36.4 weeks

title

Part 2: Plasma Concentrations of GSK525762 in Relationship With Safety and Efficacy Parameters Derived From Pharmacokinetic/Pharmacodynamic (PK/PD) Model

type

OTHER_PRE_SPECIFIED

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

Preserved source evidence · Not medical advice