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NCT02711137 · OUTCOME

Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies · Source last updated 2025-10-21

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

Measure
MEAN
Unit
%Inhibition of Total c-Myc
Interval / dispersion
Standard Error
Time frame
PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, for C1D1 and C1D8, and 24hrs post dose for C1D1

What was measured

An ex vivo assay (utilized in monotherapy only), Measuring Total c-Myc protein expressed from an exogenously added cell line (KMS12BM) to patient plasma, before and after administration of INCB057643.

Groups in this outcome

8mg QD INCB057643

cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC.

12mg QD INCB057643

12mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA,TGB.

16mg QD INCB057643

Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA

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

Analysis denominator · Participants

GroupSource count
8mg QD INCB05764311
12mg QD INCB05764351
16mg QD INCB0576437

Reported measurements

C1D1
Values in %Inhibition of Total c-Myc · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
8mg QD INCB05764324199.5Not reportedNot reportedNot reported
12mg QD INCB05764328200.1Not reportedNot reportedNot reported
16mg QD INCB05764354236.3Not reportedNot reportedNot reported
C1D8
Values in %Inhibition of Total c-Myc · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
8mg QD INCB0576433042.59Not reportedNot reportedNot reported
12mg QD INCB05764343.452.7Not reportedNot reportedNot reported
16mg QD INCB0576436555.21Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        199.5
        value
        24
      2. group Id
        OG001
        spread
        200.1
        value
        28
      3. group Id
        OG002
        spread
        236.3
        value
        54
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.59
        value
        30
      2. group Id
        OG001
        spread
        52.7
        value
        43.4
      3. group Id
        OG002
        spread
        55.21
        value
        65
    title
    C1D8
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      51
    3. group Id
      OG002
      value
      7
    units
    Participants
description
An ex vivo assay (utilized in monotherapy only), Measuring Total c-Myc protein expressed from an exogenously added cell line (KMS12BM) to patient plasma, before and after administration of INCB057643.
dispersion Type
Standard Error
groups
  1. description
    cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC.
    id
    OG000
    title
    8mg QD INCB057643
  2. description
    12mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA,TGB.
    id
    OG001
    title
    12mg QD INCB057643
  3. description
    Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA
    id
    OG002
    title
    16mg QD INCB057643
param Type
MEAN
reporting Status
POSTED
time Frame
PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, for C1D1 and C1D8, and 24hrs post dose for C1D1
title
Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay
type
SECONDARY
unit Of Measure
%Inhibition of Total c-Myc

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

Preserved source evidence · Not medical advice