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NCT02587598 · OUTCOME

Pharmacokinetics: Tmax of INCB053914 Monotherapy

Study of INCB053914 in Subjects With Advanced Malignancies · Source last updated 2021-12-08

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
Cycle 1 Day 8

Groups in this outcome

Parts 1 and 2: INCB053914 100 mg QD

INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.

Parts 1 and 2: INCB053914 50 mg BID

INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.

Parts 1 and 2: INB053914 65 mg BID

INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose

Parts 1 and 2: INB053914 80 mg BID

INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.

Parts 1 and 2: INB053914 100 mg BID

INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.

Parts 1 and 2: INB053914 115 mg BID

INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.

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

Analysis denominator · Participants

GroupSource count
Parts 1 and 2: INCB053914 100 mg QD3
Parts 1 and 2: INCB053914 50 mg BID8
Parts 1 and 2: INB053914 65 mg BID3
Parts 1 and 2: INB053914 80 mg BID14
Parts 1 and 2: INB053914 100 mg BID11
Parts 1 and 2: INB053914 115 mg BID2

Reported measurements

Source class 1
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Parts 1 and 2: INCB053914 100 mg QD2.0Not reported1.02.2Not reported
Parts 1 and 2: INCB053914 50 mg BID1.0Not reported0.54.0Not reported
Parts 1 and 2: INB053914 65 mg BID2.0Not reported2.04.0Not reported
Parts 1 and 2: INB053914 80 mg BID1.5Not reported0.54.1Not reported
Parts 1 and 2: INB053914 100 mg BID1.0Not reported.52.2Not reported
Parts 1 and 2: INB053914 115 mg BIDNANot reported1.01.1Individual values presented given N=2
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        2.2
        value
        2.0
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        4.0
        value
        1.0
      3. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        4.0
        value
        2.0
      4. group Id
        OG003
        lower Limit
        0.5
        upper Limit
        4.1
        value
        1.5
      5. group Id
        OG004
        lower Limit
        .5
        upper Limit
        2.2
        value
        1.0
      6. comment
        Individual values presented given N=2
        group Id
        OG005
        lower Limit
        1.0
        upper Limit
        1.1
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      14
    5. group Id
      OG004
      value
      11
    6. group Id
      OG005
      value
      2
    units
    Participants
dispersion Type
Full Range
groups
  1. description
    INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
    id
    OG000
    title
    Parts 1 and 2: INCB053914 100 mg QD
  2. description
    INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
    id
    OG001
    title
    Parts 1 and 2: INCB053914 50 mg BID
  3. description
    INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
    id
    OG002
    title
    Parts 1 and 2: INB053914 65 mg BID
  4. description
    INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
    id
    OG003
    title
    Parts 1 and 2: INB053914 80 mg BID
  5. description
    INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
    id
    OG004
    title
    Parts 1 and 2: INB053914 100 mg BID
  6. description
    INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
    id
    OG005
    title
    Parts 1 and 2: INB053914 115 mg BID
param Type
MEDIAN
reporting Status
POSTED
time Frame
Cycle 1 Day 8
title
Pharmacokinetics: Tmax of INCB053914 Monotherapy
type
SECONDARY
unit Of Measure
hour

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Preserved source evidence · Not medical advice