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NCT02431260 · OUTCOME

Maximum Plasma Concentration (Cmax) Analysis of INCB054329

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies · Source last updated 2019-06-14

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
Summary of steady-state PK parameters by dosing regimen at Day 15

What was measured

Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.

Analysis population: All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.

Groups in this outcome

INCB054329 Monotherapy - 15 mg QD

INCB054329 Monotherapy

INCB054329 Monotherapy - 15 mg BID

INCB054329 Monotherapy

INCB054329 Monotherapy - 22.5 mg QD

INCB054329 Monotherapy

INCB054329 Monotherapy - 30 mg QD

INCB054329 Monotherapy

INCB054329 Monotherapy - 20 mg BID

INCB054329 Monotherapy

INCB054329 Monotherapy - 22.5 mg BID

INCB054329 Monotherapy

INCB054329 Monotherapy - 25 mg BID

INCB054329 Monotherapy

INCB054329 Monotherapy - Overall Dosing Regimen

INCB054329 Monotherapy

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

Analysis denominator · Participants

GroupSource count
INCB054329 Monotherapy - 15 mg QD4
INCB054329 Monotherapy - 15 mg BID5
INCB054329 Monotherapy - 22.5 mg QD4
INCB054329 Monotherapy - 30 mg QD4
INCB054329 Monotherapy - 20 mg BID14
INCB054329 Monotherapy - 22.5 mg BID12
INCB054329 Monotherapy - 25 mg BID8
INCB054329 Monotherapy - Overall Dosing Regimen51

Reported measurements

Source class 1
Values in nM · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
INCB054329 Monotherapy - 15 mg QD27882.6Not reportedNot reportedNot reported
INCB054329 Monotherapy - 15 mg BID267201Not reportedNot reportedNot reported
INCB054329 Monotherapy - 22.5 mg QD479154Not reportedNot reportedNot reported
INCB054329 Monotherapy - 30 mg QD389393Not reportedNot reportedNot reported
INCB054329 Monotherapy - 20 mg BID652348Not reportedNot reportedNot reported
INCB054329 Monotherapy - 22.5 mg BID720472Not reportedNot reportedNot reported
INCB054329 Monotherapy - 25 mg BID449335Not reportedNot reportedNot reported
INCB054329 Monotherapy - Overall Dosing RegimenNANANot reportedNot reportedDose dependent parameter and overall summary not provided.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.6
        value
        278
      2. group Id
        OG001
        spread
        201
        value
        267
      3. group Id
        OG002
        spread
        154
        value
        479
      4. group Id
        OG003
        spread
        393
        value
        389
      5. group Id
        OG004
        spread
        348
        value
        652
      6. group Id
        OG005
        spread
        472
        value
        720
      7. group Id
        OG006
        spread
        335
        value
        449
      8. comment
        Dose dependent parameter and overall summary not provided.
        group Id
        OG007
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      14
    6. group Id
      OG005
      value
      12
    7. group Id
      OG006
      value
      8
    8. group Id
      OG007
      value
      51
    units
    Participants
description
Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
dispersion Type
Standard Deviation
groups
  1. description
    INCB054329 Monotherapy
    id
    OG000
    title
    INCB054329 Monotherapy - 15 mg QD
  2. description
    INCB054329 Monotherapy
    id
    OG001
    title
    INCB054329 Monotherapy - 15 mg BID
  3. description
    INCB054329 Monotherapy
    id
    OG002
    title
    INCB054329 Monotherapy - 22.5 mg QD
  4. description
    INCB054329 Monotherapy
    id
    OG003
    title
    INCB054329 Monotherapy - 30 mg QD
  5. description
    INCB054329 Monotherapy
    id
    OG004
    title
    INCB054329 Monotherapy - 20 mg BID
  6. description
    INCB054329 Monotherapy
    id
    OG005
    title
    INCB054329 Monotherapy - 22.5 mg BID
  7. description
    INCB054329 Monotherapy
    id
    OG006
    title
    INCB054329 Monotherapy - 25 mg BID
  8. description
    INCB054329 Monotherapy
    id
    OG007
    title
    INCB054329 Monotherapy - Overall Dosing Regimen
param Type
MEAN
population Description
All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
reporting Status
POSTED
time Frame
Summary of steady-state PK parameters by dosing regimen at Day 15
title
Maximum Plasma Concentration (Cmax) Analysis of INCB054329
type
SECONDARY
unit Of Measure
nM

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Preserved source evidence · Not medical advice