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NCT04582539 · OUTCOME

Ctrough 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
Day 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose

What was measured

Ctrough was defined as the lowest concentration of zilurgisertib.

Analysis population: PK Evaluable Population. Only participants with available data were analyzed.

Groups in this outcome

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 50 mg QD4
Zilurgisertib 100 mg QD4
Zilurgisertib 200 mg QD4
Zilurgisertib 400 mg QD4
Zilurgisertib 600 mg QD2

Reported measurements

Source class 1
Values in nanomolar · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zilurgisertib 50 mg QD21491.8Not reportedNot reportedNot reported
Zilurgisertib 100 mg QD304175Not reportedNot reportedNot reported
Zilurgisertib 200 mg QD619241Not reportedNot reportedNot reported
Zilurgisertib 400 mg QD9813130Not 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. group Id
        OG000
        spread
        91.8
        value
        214
      2. group Id
        OG001
        spread
        175
        value
        304
      3. group Id
        OG002
        spread
        241
        value
        619
      4. group Id
        OG003
        spread
        3130
        value
        981
      5. comment
        Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
        group Id
        OG004
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      2
    units
    Participants
description
Ctrough was defined as the lowest 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 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
    id
    OG000
    title
    Zilurgisertib 50 mg QD
  2. 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
    OG001
    title
    Zilurgisertib 100 mg QD
  3. 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
    OG002
    title
    Zilurgisertib 200 mg QD
  4. 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
    OG003
    title
    Zilurgisertib 400 mg QD
  5. 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
    OG004
    title
    Zilurgisertib 600 mg QD
param Type
MEAN
population Description
PK Evaluable Population. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
Day 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
title
Ctrough of Zilurgisertib
type
SECONDARY
unit Of Measure
nanomolar

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

Preserved source evidence · Not medical advice