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NCT04362007 · OUTCOME

Pharmacokinetic Outcome of Maximum Concentration (Cmax)

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/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 maximum concentration (Cmax).

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

GroupSource count
Cohort 17
Cohort 21

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Cohort 17
Cohort 21
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1249135Not reportedNot reportedNot reported
Cohort 2405Not reportedNot reportedNot reportedNot reported
Day 7

Analysis denominator · Participants

GroupSource count
Cohort 16
Cohort 20
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1380180Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        135
        value
        249
      2. group Id
        OG001
        value
        405
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        180
        value
        380
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Day 7
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Assessment of pharmacokinetic parameter maximum concentration (Cmax).
dispersion Type
Standard Deviation
groups
  1. 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
  2. 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 Maximum Concentration (Cmax)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice