NCT04362007 · OUTCOME

Pharmacokinetic Outcome of Concentration-time Curve (AUC)

A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma · Source last updated 2026-02-25

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

Measure: MEAN
Unit: ng∙h/mL
Interval / dispersion: Standard Deviation
Time frame: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose

What was measured

Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).

Analysis population: PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point.

Groups in this outcome

Cohort 1

ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).

Cohort 2

ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).

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
Cohort 1	7
Cohort 2	1

Reported measurements

Day 1

Analysis denominator · Participants

Group	Source count
Cohort 1	7
Cohort 2	1

Values in ng∙h/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1	1280	915	Not reported	Not reported	Not reported
Cohort 2	2020	Not reported	Not reported	Not reported	Not reported

Day 7

Analysis denominator · Participants

Group	Source count
Cohort 1	6
Cohort 2	0

Values in ng∙h/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1	2410	1410	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
915
value
1280
group Id
OG001
value
2020
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
1
units
Participants
title
Day 1
categories
measurements
group Id
OG000
spread
1410
value
2410
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
0
units
Participants
title
Day 7

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
1
units
Participants

description

Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).

dispersion Type

Standard Deviation

groups

description
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
id
OG000
title
Cohort 1
description
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
id
OG001
title
Cohort 2

param Type

MEAN

population Description

PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point.

reporting Status

POSTED

time Frame

Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose

title

Pharmacokinetic Outcome of Concentration-time Curve (AUC)

type

SECONDARY

unit Of Measure

ng∙h/mL

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

Preserved source evidence · Not medical advice