Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02587598 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      12
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      6
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      9
    10. group Id
      BG009
      value
      3
    11. group Id
      BG010
      value
      14
    12. group Id
      BG011
      value
      97
    units
    Participants
groups
  1. description
    INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
    id
    BG000
    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
    BG001
    title
    Parts 1 and 2: INCB053914 50 mg BID
  3. description
    INCB053914 will be self-administered orally twice day as a 65mg immediate release monotherapy dose.
    id
    BG002
    title
    Parts 1 and 2: INB053914 65 mg BID
  4. description
    INCB053914 will be self-administered orally twice day as a 80mg immediate release monotherapy dose.
    id
    BG003
    title
    Parts 1 and 2: INB053914 80 mg BID
  5. description
    INCB053914 will be self-administered orally twice day s a 100mg immediate release monotherapy dose.
    id
    BG004
    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
    BG005
    title
    Parts 1 and 2: INB053914 115 mg BID
  7. description
    Combination Treatment Group A: 50 mg BID + I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.
    id
    BG006
    title
    Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
  8. description
    Combination Treatment Group B: Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914 50 mg BID.
    id
    BG007
    title
    Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
  9. description
    Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
    id
    BG008
    title
    Part 3 and 4 - INCB053914 80 mg BID + Azacitidine
  10. description
    Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
    id
    BG009
    title
    Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib
  11. description
    Combination Treatment Group C: INCB053914 80 mg + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
    id
    BG010
    title
    Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib
  12. description
    Total of all reporting groups
    id
    BG011
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.25
          value
          59.5
        2. group Id
          BG001
          spread
          14.64
          value
          67.1
        3. group Id
          BG002
          spread
          9.18
          value
          67.3
        4. group Id
          BG003
          spread
          11.50
          value
          70.8
        5. group Id
          BG004
          spread
          7.19
          value
          76.5
        6. group Id
          BG005
          spread
          9.67
          value
          70.5
        7. group Id
          BG006
          spread
          6.46
          value
          70.8
        8. group Id
          BG007
          spread
          20.83
          value
          60.9
        9. group Id
          BG008
          spread
          6.31
          value
          72.9
        10. group Id
          BG009
          spread
          5.0
          value
          70.0
        11. group Id
          BG010
          spread
          7.48
          value
          72.6
        12. group Id
          BG011
          spread
          11.38
          value
          70.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          47
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          50
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          13
        12. group Id
          BG011
          value
          83
      title
      White/Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          11
      title
      Black/African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
      title
      Other
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
      title
      Native Hawaiian/Pacific Islander
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          3
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          11
        12. group Id
          BG011
          value
          89
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          5
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      12
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      6
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      9
    10. group Id
      BG009
      value
      3
    11. group Id
      BG010
      value
      14
    12. group Id
      BG011
      value
      97
    units
    Participants
groups
  1. description
    INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
    id
    BG000
    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
    BG001
    title
    Parts 1 and 2: INCB053914 50 mg BID
  3. description
    INCB053914 will be self-administered orally twice day as a 65mg immediate release monotherapy dose.
    id
    BG002
    title
    Parts 1 and 2: INB053914 65 mg BID
  4. description
    INCB053914 will be self-administered orally twice day as a 80mg immediate release monotherapy dose.
    id
    BG003
    title
    Parts 1 and 2: INB053914 80 mg BID
  5. description
    INCB053914 will be self-administered orally twice day s a 100mg immediate release monotherapy dose.
    id
    BG004
    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
    BG005
    title
    Parts 1 and 2: INB053914 115 mg BID
  7. description
    Combination Treatment Group A: 50 mg BID + I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.
    id
    BG006
    title
    Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
  8. description
    Combination Treatment Group B: Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914 50 mg BID.
    id
    BG007
    title
    Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
  9. description
    Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
    id
    BG008
    title
    Part 3 and 4 - INCB053914 80 mg BID + Azacitidine
  10. description
    Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
    id
    BG009
    title
    Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib
  11. description
    Combination Treatment Group C: INCB053914 80 mg + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
    id
    BG010
    title
    Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib
  12. description
    Total of all reporting groups
    id
    BG011
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.25
          value
          59.5
        2. group Id
          BG001
          spread
          14.64
          value
          67.1
        3. group Id
          BG002
          spread
          9.18
          value
          67.3
        4. group Id
          BG003
          spread
          11.50
          value
          70.8
        5. group Id
          BG004
          spread
          7.19
          value
          76.5
        6. group Id
          BG005
          spread
          9.67
          value
          70.5
        7. group Id
          BG006
          spread
          6.46
          value
          70.8
        8. group Id
          BG007
          spread
          20.83
          value
          60.9
        9. group Id
          BG008
          spread
          6.31
          value
          72.9
        10. group Id
          BG009
          spread
          5.0
          value
          70.0
        11. group Id
          BG010
          spread
          7.48
          value
          72.6
        12. group Id
          BG011
          spread
          11.38
          value
          70.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          47
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          50
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          13
        12. group Id
          BG011
          value
          83
      title
      White/Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          11
      title
      Black/African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
      title
      Other
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
      title
      Native Hawaiian/Pacific Islander
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          3
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          11
        12. group Id
          BG011
          value
          89
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          5
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice