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NCT02711137 · OUTCOME

Tmax: Time to Maximum 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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8

What was measured

Time to maximum plasma concentration of 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

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 hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
8mg QD INCB0576432.00Not reported1.0024.00Not reported
12mg QD INCB0576432Not reported0.508.00Not reported
16mg QD INCB0576432.00Not reported2.004.00Not reported
C1D8

Analysis denominator · Participants

GroupSource count
8mg QD INCB05764310
12mg QD INCB05764389
16mg QD INCB0576437
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
8mg QD INCB0576431.00Not reported1.004.00Not reported
12mg QD INCB0576432Not reported0.508.00Not reported
16mg QD INCB0576432.00Not reported2.004.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        24.00
        value
        2.00
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        8.00
        value
        2
      3. group Id
        OG002
        lower Limit
        2.00
        upper Limit
        4.00
        value
        2.00
    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
        lower Limit
        1.00
        upper Limit
        4.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        8.00
        value
        2
      3. group Id
        OG002
        lower Limit
        2.00
        upper Limit
        4.00
        value
        2.00
    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
Time to maximum plasma concentration of INCB057643 administered as monotherapy in fasted state
dispersion Type
Full Range
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
    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
MEDIAN
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
Tmax: Time to Maximum Plasma Concentration of INCB057643
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice