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NCT04582539 · OUTCOME

Cmax 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
MEAN
Unit
nanomolar
Interval / dispersion
Standard Deviation
Time frame
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6 hours post-dose

What was measured

Cmax was defined as the maximum concentration of zilurgisertib.

Analysis population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of zilurgisertib and provided at least 1 postdose plasma sample (1 PK measurement). 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 nanomolar · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zilurgisertib 25 mg QD79.9NANot reportedNot reportedStandard deviation was not calculated for a single participant.
Zilurgisertib 50 mg QD18180.4Not reportedNot reportedNot reported
Zilurgisertib 100 mg QD249100Not reportedNot reportedNot reported
Zilurgisertib 200 mg QD569291Not reportedNot reportedNot reported
Zilurgisertib 400 mg QD1950652Not reportedNot reportedNot reported
Zilurgisertib 600 mg QDNANANot reportedNot reportedTwo 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 nanomolar · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zilurgisertib 50 mg QD350131Not reportedNot reportedNot reported
Zilurgisertib 100 mg QD636330Not reportedNot reportedNot reported
Zilurgisertib 200 mg QD1360613Not reportedNot reportedNot reported
Zilurgisertib 400 mg QD26204620Not reportedNot reportedNot reported
Zilurgisertib 600 mg QDNANANot reportedNot reportedTwo 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
        Standard deviation was not calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        79.9
      2. group Id
        OG001
        spread
        80.4
        value
        181
      3. group Id
        OG002
        spread
        100
        value
        249
      4. group Id
        OG003
        spread
        291
        value
        569
      5. group Id
        OG004
        spread
        652
        value
        1950
      6. comment
        Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
        group Id
        OG005
        spread
        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
        spread
        131
        value
        350
      2. group Id
        OG002
        spread
        330
        value
        636
      3. group Id
        OG003
        spread
        613
        value
        1360
      4. group Id
        OG004
        spread
        4620
        value
        2620
      5. comment
        Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
        group Id
        OG005
        spread
        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
Cmax was defined as the maximum concentration of zilurgisertib.
dispersion Type
Standard Deviation
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
MEAN
population Description
Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of zilurgisertib and provided at least 1 postdose plasma sample (1 PK measurement). 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 hours post-dose
title
Cmax of Zilurgisertib
type
SECONDARY
unit Of Measure
nanomolar

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Preserved source evidence · Not medical advice