NCT04362007 · OUTCOME

Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax)

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: MEDIAN
Unit: h
Interval / dispersion: Full Range
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 time to maximum concentration (Tmax).

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 h · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Cohort 1	0.98	Not reported	0.50	3.00	Not reported
Cohort 2	0.48	Not reported	0.48	0.48	Not reported

Day 7

Analysis denominator · Participants

Group	Source count
Cohort 1	6
Cohort 2	0

Values in h · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Cohort 1	0.94	Not reported	0.42	2.98	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.50
upper Limit
3.00
value
0.98
group Id
OG001
lower Limit
0.48
upper Limit
0.48
value
0.48
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
1
units
Participants
title
Day 1
categories
measurements
group Id
OG000
lower Limit
0.42
upper Limit
2.98
value
0.94
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 time to maximum concentration (Tmax).

dispersion Type

Full Range

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

MEDIAN

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 Time to Maximum Concentration (Tmax)

type

SECONDARY

unit Of Measure

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

Preserved source evidence · Not medical advice