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NCT04582539 · OUTCOME

Percentage Change in Hepcidin From Cycle 1 Day 15 to Cycle 7 Day 1

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
percent change
Interval / dispersion
Standard Deviation
Time frame
from Cycle 1 Day 15 to Cycle 7 Day 1

What was measured

Percentage change was calculated as the (\[post-baseline value minus the baseline value\] / \[baseline value\]) \* 100.

Analysis population: Pharmacodynamic (PD) Evaluable Population: all participants who received at least 1 dose of zilurgisertib and provided at least 1 plasma/serum sample (1 PD measurement)

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 QD5
Zilurgisertib 600 mg QD3

Reported measurements

Source class 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zilurgisertib 50 mg QD-24.5341.69Not reportedNot reportedNot reported
Zilurgisertib 100 mg QD-16.2547.06Not reportedNot reportedNot reported
Zilurgisertib 200 mg QD-11.2539.97Not reportedNot reportedNot reported
Zilurgisertib 400 mg QD-59.0232.35Not reportedNot reportedNot reported
Zilurgisertib 600 mg QD-63.7944.23Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.69
        value
        -24.53
      2. group Id
        OG001
        spread
        47.06
        value
        -16.25
      3. group Id
        OG002
        spread
        39.97
        value
        -11.25
      4. group Id
        OG003
        spread
        32.35
        value
        -59.02
      5. group Id
        OG004
        spread
        44.23
        value
        -63.79
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
      5
    5. group Id
      OG004
      value
      3
    units
    Participants
description
Percentage change was calculated as the (\[post-baseline value minus the baseline value\] / \[baseline value\]) \* 100.
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
Pharmacodynamic (PD) Evaluable Population: all participants who received at least 1 dose of zilurgisertib and provided at least 1 plasma/serum sample (1 PD measurement)
reporting Status
POSTED
time Frame
from Cycle 1 Day 15 to Cycle 7 Day 1
title
Percentage Change in Hepcidin From Cycle 1 Day 15 to Cycle 7 Day 1
type
SECONDARY
unit Of Measure
percent change

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

Preserved source evidence · Not medical advice