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NCT04362007 · OUTCOME

Pharmacokinetic Outcome of Elimination Half Life (t½)

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
h
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 elimination half life (t½).

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 h · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 19.71.2Not reportedNot reportedNot reported
Cohort 2NANot reportedNot reportedNot reportedFor 1 subject in cohort 2, all plasma concentrations and all PK parameters on Cycle 1 Day 7 were excluded from the calculation of descriptive statistics because the subject was administered an unplanned dose (210 mg) on Cycle 1 Day 2, which might affect the assessment of ASTX660 PK results for the planned dose (150 mg) on Cycle 1 Day 7
Day 7

Analysis denominator · Participants

GroupSource count
Cohort 16
Cohort 20
Values in h · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 135.35.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.2
        value
        9.7
      2. comment
        For 1 subject in cohort 2, all plasma concentrations and all PK parameters on Cycle 1 Day 7 were excluded from the calculation of descriptive statistics because the subject was administered an unplanned dose (210 mg) on Cycle 1 Day 2, which might affect the assessment of ASTX660 PK results for the planned dose (150 mg) on Cycle 1 Day 7
        group Id
        OG001
        value
        NA
    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
        5.5
        value
        35.3
    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 elimination half life (t½).
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 Elimination Half Life (t½)
type
SECONDARY
unit Of Measure
h

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Preserved source evidence · Not medical advice