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NCT02587598 · OUTCOME

Pharmacokinetics: Cmax 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
MEAN
Unit
nM
Interval / dispersion
Standard Deviation
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 nM · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Parts 1 and 2: INCB053914 100 mg QD352126Not reportedNot reportedNot reported
Parts 1 and 2: INCB053914 50 mg BID227188Not reportedNot reportedNot reported
Parts 1 and 2: INB053914 65 mg BID333276Not reportedNot reportedNot reported
Parts 1 and 2: INB053914 80 mg BID591447Not reportedNot reportedNot reported
Parts 1 and 2: INB053914 100 mg BID796659Not reportedNot reportedNot reported
Parts 1 and 2: INB053914 115 mg BID578131Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        126
        value
        352
      2. group Id
        OG001
        spread
        188
        value
        227
      3. group Id
        OG002
        spread
        276
        value
        333
      4. group Id
        OG003
        spread
        447
        value
        591
      5. group Id
        OG004
        spread
        659
        value
        796
      6. group Id
        OG005
        spread
        131
        value
        578
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
Standard Deviation
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
MEAN
reporting Status
POSTED
time Frame
Cycle 1 Day 8
title
Pharmacokinetics: Cmax of INCB053914 Monotherapy
type
SECONDARY
unit Of Measure
nM

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

Preserved source evidence · Not medical advice