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NCT02711137 · OUTCOME

Cmax: Maximum Observed Plasma Concentration of INCB057643.

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
nM
Interval / dispersion
Standard Deviation
Time frame
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8

What was measured

Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fasted state.

Analysis population: PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed

Groups in this outcome

8mg QD INCB057643

Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA

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 INCB05764312
12mg QD INCB05764399
16mg QD INCB0576437

Reported measurements

C1D1

Analysis denominator · Participants

GroupSource count
8mg QD INCB05764312
12mg QD INCB05764399
16mg QD INCB0576437
Values in nM · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
8mg QD INCB05764320183.6Not reportedNot reportedNot reported
12mg QD INCB05764326694.7Not reportedNot reportedNot reported
16mg QD INCB05764334393.2Not reportedNot reportedNot reported
C1D8

Analysis denominator · Participants

GroupSource count
8mg QD INCB05764310
12mg QD INCB05764389
16mg QD INCB0576437
Values in nM · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
8mg QD INCB05764321093.2Not reportedNot reportedNot reported
12mg QD INCB057643293113Not reportedNot reportedNot reported
16mg QD INCB057643340165Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        83.6
        value
        201
      2. group Id
        OG001
        spread
        94.7
        value
        266
      3. group Id
        OG002
        spread
        93.2
        value
        343
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        99
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        93.2
        value
        210
      2. group Id
        OG001
        spread
        113
        value
        293
      3. group Id
        OG002
        spread
        165
        value
        340
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        89
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    C1D8
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      99
    3. group Id
      OG002
      value
      7
    units
    Participants
description
Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fasted state.
dispersion Type
Standard Deviation
groups
  1. description
    Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA
    id
    OG000
    title
    8mg QD INCB057643
  2. description
    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
population Description
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
reporting Status
POSTED
time Frame
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8
title
Cmax: Maximum Observed Plasma Concentration of INCB057643.
type
SECONDARY
unit Of Measure
nM

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

Preserved source evidence · Not medical advice