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NCT04582539 · OUTCOME

Tmax of Zilurgisertib

To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma · Source last updated 2025-10-22

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose

What was measured

tmax was defined as the time to the maximum observed concentration of zilurgisertib.

Analysis population: PK Evaluable Population. Only participants with available data were analyzed. One participant who was supposed to receive 100 mg actually received 25 mg from Day 1 to Day 16.

Groups in this outcome

Zilurgisertib 25 mg QD

Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 25 milligrams (mg) once daily (QD) administered as a monotherapy from Day 1 to Day 16.

Zilurgisertib 50 mg QD

Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.

Zilurgisertib 100 mg QD

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.

Zilurgisertib 200 mg QD

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.

Zilurgisertib 400 mg QD

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.

Zilurgisertib 600 mg QD

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Zilurgisertib 25 mg QD1
Zilurgisertib 50 mg QD4
Zilurgisertib 100 mg QD4
Zilurgisertib 200 mg QD4
Zilurgisertib 400 mg QD4
Zilurgisertib 600 mg QD2

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Zilurgisertib 25 mg QD1
Zilurgisertib 50 mg QD4
Zilurgisertib 100 mg QD4
Zilurgisertib 200 mg QD4
Zilurgisertib 400 mg QD4
Zilurgisertib 600 mg QD2
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Zilurgisertib 25 mg QD2.0Not reportedNANAMin, max are not reported for a single participant.
Zilurgisertib 50 mg QD2.0Not reported2.04.0Not reported
Zilurgisertib 100 mg QD2.0Not reported2.02.0Not reported
Zilurgisertib 200 mg QD3.0Not reported2.04.0Not reported
Zilurgisertib 400 mg QD2.0Not reported2.02.0Not reported
Zilurgisertib 600 mg QDNANot reportedNANATwo participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Zilurgisertib 25 mg QD0
Zilurgisertib 50 mg QD4
Zilurgisertib 100 mg QD4
Zilurgisertib 200 mg QD4
Zilurgisertib 400 mg QD2
Zilurgisertib 600 mg QD2
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Zilurgisertib 50 mg QD2.0Not reported2.06.0Not reported
Zilurgisertib 100 mg QD2.0Not reported2.02.0Not reported
Zilurgisertib 200 mg QD3.0Not reported2.06.0Not reported
Zilurgisertib 400 mg QD2.0Not reported2.04.0Not reported
Zilurgisertib 600 mg QDNANot reportedNANATwo participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Min, max are not reported for a single participant.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        2.0
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        4.0
        value
        2.0
      3. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        2.0
        value
        2.0
      4. group Id
        OG003
        lower Limit
        2.0
        upper Limit
        4.0
        value
        3.0
      5. group Id
        OG004
        lower Limit
        2.0
        upper Limit
        2.0
        value
        2.0
      6. comment
        Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        2
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        6.0
        value
        2.0
      2. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        2.0
        value
        2.0
      3. group Id
        OG003
        lower Limit
        2.0
        upper Limit
        6.0
        value
        3.0
      4. group Id
        OG004
        lower Limit
        2.0
        upper Limit
        4.0
        value
        2.0
      5. comment
        Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        2
      units
      Participants
    title
    Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      2
    units
    Participants
description
tmax was defined as the time to the maximum observed concentration of zilurgisertib.
dispersion Type
Full Range
groups
  1. description
    Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 25 milligrams (mg) once daily (QD) administered as a monotherapy from Day 1 to Day 16.
    id
    OG000
    title
    Zilurgisertib 25 mg QD
  2. description
    Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
    id
    OG001
    title
    Zilurgisertib 50 mg QD
  3. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
    id
    OG002
    title
    Zilurgisertib 100 mg QD
  4. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
    id
    OG003
    title
    Zilurgisertib 200 mg QD
  5. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
    id
    OG004
    title
    Zilurgisertib 400 mg QD
  6. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
    id
    OG005
    title
    Zilurgisertib 600 mg QD
param Type
MEDIAN
population Description
PK Evaluable Population. Only participants with available data were analyzed. One participant who was supposed to receive 100 mg actually received 25 mg from Day 1 to Day 16.
reporting Status
POSTED
time Frame
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
title
Tmax of Zilurgisertib
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice