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NCT04582539 · OUTCOME

Recommended Dose for Expansion (RDE)

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
NUMBER
Unit
milligrams
Interval / dispersion
Not reported
Time frame
up to Day 28

What was measured

RDE doses were defined as pharmacodynamically active. RDE doses were not to have exceeded the MTD defined in each treatment group.

Analysis population: Full Analysis Set-MDS

Groups in this outcome

All Participants

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 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
All Participants21

Reported measurements

Source class 1
Values in milligrams · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All ParticipantsNANot reportedNot reportedNot reportedThe RDE was not established because, at the time of early study termination, dose escalation was ongoing and the dose that had evidence of the best pharmacologic activity while being below the MTD had not yet been identified.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The RDE was not established because, at the time of early study termination, dose escalation was ongoing and the dose that had evidence of the best pharmacologic activity while being below the MTD had not yet been identified.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
RDE doses were defined as pharmacodynamically active. RDE doses were not to have exceeded the MTD defined in each treatment group.
groups
  1. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib QD administered as a monotherapy for up to 6 months.
    id
    OG000
    title
    All Participants
param Type
NUMBER
population Description
Full Analysis Set-MDS
reporting Status
POSTED
time Frame
up to Day 28
title
Recommended Dose for Expansion (RDE)
type
PRIMARY
unit Of Measure
milligrams

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

Preserved source evidence · Not medical advice