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NCT02431260 · OUTCOME

Time to Maximum Plasma Concentration (Tmax) 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
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
Summary of steady-state PK parameters by dosing regimen at Day 15

What was measured

Tmax is the time to maximum (peak) drug serum concentration. 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 hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
INCB054329 Monotherapy - 15 mg QD1.0Not reported0.521.0Not reported
INCB054329 Monotherapy - 15 mg BID0.93Not reported0.51.1Not reported
INCB054329 Monotherapy - 22.5 mg QD0.53Not reported0.51.0Not reported
INCB054329 Monotherapy - 30 mg QD1.0Not reported0.521.0Not reported
INCB054329 Monotherapy - 20 mg BID1.0Not reported0.482.0Not reported
INCB054329 Monotherapy - 22.5 mg BID1.0Not reported0.54.1Not reported
INCB054329 Monotherapy - 25 mg BID0.77Not reported0.502.2Not reported
INCB054329 Monotherapy - Overall Dosing Regimen1.0Not reported0.484.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.52
        upper Limit
        1.0
        value
        1.0
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        1.1
        value
        0.93
      3. group Id
        OG002
        lower Limit
        0.5
        upper Limit
        1.0
        value
        0.53
      4. group Id
        OG003
        lower Limit
        0.52
        upper Limit
        1.0
        value
        1.0
      5. group Id
        OG004
        lower Limit
        0.48
        upper Limit
        2.0
        value
        1.0
      6. group Id
        OG005
        lower Limit
        0.5
        upper Limit
        4.1
        value
        1.0
      7. group Id
        OG006
        lower Limit
        0.50
        upper Limit
        2.2
        value
        0.77
      8. group Id
        OG007
        lower Limit
        0.48
        upper Limit
        4.1
        value
        1.0
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
Tmax is the time to maximum (peak) drug serum concentration. Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
dispersion Type
Full Range
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
MEDIAN
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
Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329
type
SECONDARY
unit Of Measure
hour

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

Preserved source evidence · Not medical advice