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NCT02431260 · OUTCOME

Cl/F 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
L/h
Interval / dispersion
Standard Deviation
Time frame
Summary of steady-state PK parameters by dosing regimen at Day 15

What was measured

Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.

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 BID

INCB054329 Monotherapy

INCB054329 Monotherapy - 30 mg QD

INCB054329 Monotherapy

INCB054329 Monotherapy - 20 mg BID

INCB054329 Monotherapy

INCB054329 Monotherapy - 22.5 mg QD

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 BID4
INCB054329 Monotherapy - 22.5 mg BID4
INCB054329 Monotherapy - 30 mg QD4
INCB054329 Monotherapy - 20 mg BID14
INCB054329 Monotherapy - 22.5 mg QD11
INCB054329 Monotherapy - 25 mg BID7
INCB054329 Monotherapy - Overall Dosing Regimen48

Reported measurements

Source class 1
Values in L/h · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
INCB054329 Monotherapy - 15 mg QD61.821.3Not reportedNot reportedNot reported
INCB054329 Monotherapy - 15 mg BID85.042.9Not reportedNot reportedNot reported
INCB054329 Monotherapy - 22.5 mg BID81.729.4Not reportedNot reportedNot reported
INCB054329 Monotherapy - 30 mg QD234184Not reportedNot reportedNot reported
INCB054329 Monotherapy - 20 mg BID92.3201Not reportedNot reportedNot reported
INCB054329 Monotherapy - 22.5 mg QD48.333.7Not reportedNot reportedNot reported
INCB054329 Monotherapy - 25 mg BID130127Not reportedNot reportedNot reported
INCB054329 Monotherapy - Overall Dosing Regimen95.5135Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.3
        value
        61.8
      2. group Id
        OG001
        spread
        42.9
        value
        85.0
      3. group Id
        OG002
        spread
        29.4
        value
        81.7
      4. group Id
        OG003
        spread
        184
        value
        234
      5. group Id
        OG004
        spread
        201
        value
        92.3
      6. group Id
        OG005
        spread
        33.7
        value
        48.3
      7. group Id
        OG006
        spread
        127
        value
        130
      8. group Id
        OG007
        spread
        135
        value
        95.5
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      14
    6. group Id
      OG005
      value
      11
    7. group Id
      OG006
      value
      7
    8. group Id
      OG007
      value
      48
    units
    Participants
description
Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.
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 BID
  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 QD
  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
Cl/F Analysis of INCB054329
type
SECONDARY
unit Of Measure
L/h

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Preserved source evidence · Not medical advice