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NCT02587598 · OUTCOME

Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD)

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
Percentage of Inhibition
Interval / dispersion
Full Range
Time frame
1 month

What was measured

Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay

Analysis population: The PD evaluable population includes those in the safety population who have at least 1 valid PD measurements at both pre- and postdose.

Groups in this outcome

Parts 1 and 2: INCB053914 100 mg QD

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

Parts 1 and 2: INCB053914 50 mg BID

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

Parts 1 and 2: INB053914 65 mg BID

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

Parts 1 and 2: INB053914 80 mg BID

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

Parts 1 and 2: INB053914 100 mg BID

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

Parts 1 and 2: INB053914 115 mg BID

INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a 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
Parts 1 and 2: INCB053914 100 mg QD4
Parts 1 and 2: INCB053914 50 mg BID10
Parts 1 and 2: INB053914 65 mg BID3
Parts 1 and 2: INB053914 80 mg BID3
Parts 1 and 2: INB053914 100 mg BID8
Parts 1 and 2: INB053914 115 mg BID3

Reported measurements

Source class 1
Values in Percentage of Inhibition · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Parts 1 and 2: INCB053914 100 mg QD41Not reported1667Not reported
Parts 1 and 2: INCB053914 50 mg BID37Not reported1759Not reported
Parts 1 and 2: INB053914 65 mg BID68Not reported5291Not reported
Parts 1 and 2: INB053914 80 mg BID78Not reported63104Not reported
Parts 1 and 2: INB053914 100 mg BID55Not reported2892Not reported
Parts 1 and 2: INB053914 115 mg BID58Not reported3480Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16
        upper Limit
        67
        value
        41
      2. group Id
        OG001
        lower Limit
        17
        upper Limit
        59
        value
        37
      3. group Id
        OG002
        lower Limit
        52
        upper Limit
        91
        value
        68
      4. group Id
        OG003
        lower Limit
        63
        upper Limit
        104
        value
        78
      5. group Id
        OG004
        lower Limit
        28
        upper Limit
        92
        value
        55
      6. group Id
        OG005
        lower Limit
        34
        upper Limit
        80
        value
        58
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      3
    units
    Participants
description
Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay
dispersion Type
Full Range
groups
  1. description
    INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy.
    id
    OG000
    title
    Parts 1 and 2: INCB053914 100 mg QD
  2. description
    INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy.
    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 tablet as a monotherapy.
    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 tablet as a monotherapy.
    id
    OG003
    title
    Parts 1 and 2: INB053914 80 mg BID
  5. description
    INCB053914 will be self-administered orally twice day in as a 100mg immediate release tablet as a monotherapy.
    id
    OG004
    title
    Parts 1 and 2: INB053914 100 mg BID
  6. description
    INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a monotherapy.
    id
    OG005
    title
    Parts 1 and 2: INB053914 115 mg BID
param Type
MEAN
population Description
The PD evaluable population includes those in the safety population who have at least 1 valid PD measurements at both pre- and postdose.
reporting Status
POSTED
time Frame
1 month
title
Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD)
type
SECONDARY
unit Of Measure
Percentage of Inhibition

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Preserved source evidence · Not medical advice