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NCT02530476 · BASELINE

Baseline characteristics

Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia · Source last updated 2020-03-31

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
      3
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      17
    units
    Participants
groups
  1. description
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    BG000
    title
    Phase I Group 1 Selinexor + Sorafenib
  2. description
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.
    id
    BG001
    title
    Phase I Group 2 Selinexor + Sorafenib
  3. description
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    BG002
    title
    Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)
  4. description
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    BG003
    title
    Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. 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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          11
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          81
          value
          78.5
        2. group Id
          BG001
          lower Limit
          68
          upper Limit
          74
          value
          68
        3. group Id
          BG002
          lower Limit
          38
          upper Limit
          75
          value
          63
        4. group Id
          BG003
          lower Limit
          31
          upper Limit
          79
          value
          77
        5. group Id
          BG004
          lower Limit
          24
          upper Limit
          81
          value
          68
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. 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
        title
        American Indian or Alaska Native
      2. 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
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          9
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          16
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      17
    units
    Participants
groups
  1. description
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    BG000
    title
    Phase I Group 1 Selinexor + Sorafenib
  2. description
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.
    id
    BG001
    title
    Phase I Group 2 Selinexor + Sorafenib
  3. description
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    BG002
    title
    Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)
  4. description
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    BG003
    title
    Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. 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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          11
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          81
          value
          78.5
        2. group Id
          BG001
          lower Limit
          68
          upper Limit
          74
          value
          68
        3. group Id
          BG002
          lower Limit
          38
          upper Limit
          75
          value
          63
        4. group Id
          BG003
          lower Limit
          31
          upper Limit
          79
          value
          77
        5. group Id
          BG004
          lower Limit
          24
          upper Limit
          81
          value
          68
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. 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
        title
        American Indian or Alaska Native
      2. 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
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          9
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          16
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice