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NCT02587598 · OUTCOME

Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Approximately 7 months

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.

Parts 3 and 4: INCB053914 50 mg BID + Cytarabine

Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine

Parts 3 and 4: INCB053914 50 mg BID + Azacitidine

Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine

Parts 3 and 4: INCB053914 80 mg BID + Azacitine

Combination Treatment Group B: INCB053914 80 mg BID + Azacitine

Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib

Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib

Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib

Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib

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 BID11
Parts 1 and 2: INB053914 65 mg BID4
Parts 1 and 2: INB053914 80 mg BID21
Parts 1 and 2: INB053914 100 mg BID12
Parts 1 and 2: INB053914 115 mg BID3
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine6
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine7
Parts 3 and 4: INCB053914 80 mg BID + Azacitine9
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib3
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib14

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Parts 1 and 2: INCB053914 100 mg QD4Not reportedNot reportedNot reportedNot reported
Parts 1 and 2: INCB053914 50 mg BID11Not reportedNot reportedNot reportedNot reported
Parts 1 and 2: INB053914 65 mg BID4Not reportedNot reportedNot reportedNot reported
Parts 1 and 2: INB053914 80 mg BID21Not reportedNot reportedNot reportedNot reported
Parts 1 and 2: INB053914 100 mg BID12Not reportedNot reportedNot reportedNot reported
Parts 1 and 2: INB053914 115 mg BID6Not reportedNot reportedNot reportedNot reported
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine6Not reportedNot reportedNot reportedNot reported
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine7Not reportedNot reportedNot reportedNot reported
Parts 3 and 4: INCB053914 80 mg BID + Azacitine9Not reportedNot reportedNot reportedNot reported
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib3Not reportedNot reportedNot reportedNot reported
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        21
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        7
      9. group Id
        OG008
        value
        9
      10. group Id
        OG009
        value
        3
      11. group Id
        OG010
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      7
    9. group Id
      OG008
      value
      9
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      14
    units
    Participants
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
  7. description
    Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
    id
    OG006
    title
    Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
  8. description
    Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
    id
    OG007
    title
    Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
  9. description
    Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
    id
    OG008
    title
    Parts 3 and 4: INCB053914 80 mg BID + Azacitine
  10. description
    Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
    id
    OG009
    title
    Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
  11. description
    Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
    id
    OG010
    title
    Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
param Type
NUMBER
reporting Status
POSTED
time Frame
Approximately 7 months
title
Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice