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NCT03037385 · BASELINE

Baseline characteristics

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors · Source last updated 2025-05-31

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
      2
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      13
    5. group Id
      BG004
      value
      11
    6. group Id
      BG005
      value
      12
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      5
    9. group Id
      BG008
      value
      4
    10. group Id
      BG009
      value
      528
    11. group Id
      BG010
      value
      590
    units
    Participants
groups
  1. description
    Participants received pralsetinib 30 milligrams (mg) orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG000
    title
    Phase I: Pralsetinib 30 mg
  2. description
    Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG001
    title
    Phase I: Pralsetinib 60 mg
  3. description
    Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG002
    title
    Phase I: Pralsetinib 100 mg
  4. description
    Participants received pralsetinib 200 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG003
    title
    Phase I: Pralsetinib 200 mg
  5. description
    Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG004
    title
    Phase I: Pralsetinib 300 mg
  6. description
    Participants received pralsetinib 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG005
    title
    Phase I: Pralsetinib 400 mg
  7. description
    Participants received pralsetinib 600 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG006
    title
    Phase I: Pralsetinib 600 mg
  8. description
    Participants received pralsetinib 100 mg, orally, twice a day (BID) until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG007
    title
    Phase I: Pralsetinib 100/100 mg
  9. description
    Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG008
    title
    Phase I: Pralsetinib 200/100 mg
  10. description
    Participants with advanced NSCLC, advanced non-resectable TC and other advanced non-resectable solid tumors with various rearranged during transfection (RET)-alterations were enrolled in this arm to receive pralsetinib, 400 mg, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG009
    title
    Phase II: Pralsetinib 400 mg
  11. description
    Total of all reporting groups
    id
    BG010
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.2
          value
          54.5
        2. group Id
          BG001
          spread
          18.0
          value
          49.5
        3. group Id
          BG002
          spread
          13.2
          value
          51.2
        4. group Id
          BG003
          spread
          13.6
          value
          53.8
        5. group Id
          BG004
          spread
          11.0
          value
          60.6
        6. group Id
          BG005
          spread
          17.8
          value
          49.2
        7. group Id
          BG006
          spread
          9.1
          value
          59.5
        8. group Id
          BG007
          spread
          11.09
          value
          63.0
        9. group Id
          BG008
          spread
          18.25
          value
          61.8
        10. group Id
          BG009
          spread
          12.6
          value
          57.7
        11. group Id
          BG010
          spread
          12.8
          value
          57.5
    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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          257
        11. group Id
          BG010
          value
          283
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          271
        11. group Id
          BG010
          value
          307
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          19
        11. group Id
          BG010
          value
          28
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          465
        11. group Id
          BG010
          value
          516
        title
        Not Hispanic or Latino
      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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          44
        11. group Id
          BG010
          value
          46
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          203
        11. group Id
          BG010
          value
          209
      title
      Asian
    2. 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
          2
        11. group Id
          BG010
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          6
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          284
        11. group Id
          BG010
          value
          331
      title
      White
    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
          3
        11. group Id
          BG010
          value
          3
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        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
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          32
        11. group Id
          BG010
          value
          39
      title
      Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety population included all participants who had received at least 1 dose of the study drug regardless of the starting dose levels.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      2
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      13
    5. group Id
      BG004
      value
      11
    6. group Id
      BG005
      value
      12
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      5
    9. group Id
      BG008
      value
      4
    10. group Id
      BG009
      value
      528
    11. group Id
      BG010
      value
      590
    units
    Participants
groups
  1. description
    Participants received pralsetinib 30 milligrams (mg) orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG000
    title
    Phase I: Pralsetinib 30 mg
  2. description
    Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG001
    title
    Phase I: Pralsetinib 60 mg
  3. description
    Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG002
    title
    Phase I: Pralsetinib 100 mg
  4. description
    Participants received pralsetinib 200 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG003
    title
    Phase I: Pralsetinib 200 mg
  5. description
    Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG004
    title
    Phase I: Pralsetinib 300 mg
  6. description
    Participants received pralsetinib 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG005
    title
    Phase I: Pralsetinib 400 mg
  7. description
    Participants received pralsetinib 600 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG006
    title
    Phase I: Pralsetinib 600 mg
  8. description
    Participants received pralsetinib 100 mg, orally, twice a day (BID) until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG007
    title
    Phase I: Pralsetinib 100/100 mg
  9. description
    Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG008
    title
    Phase I: Pralsetinib 200/100 mg
  10. description
    Participants with advanced NSCLC, advanced non-resectable TC and other advanced non-resectable solid tumors with various rearranged during transfection (RET)-alterations were enrolled in this arm to receive pralsetinib, 400 mg, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    BG009
    title
    Phase II: Pralsetinib 400 mg
  11. description
    Total of all reporting groups
    id
    BG010
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.2
          value
          54.5
        2. group Id
          BG001
          spread
          18.0
          value
          49.5
        3. group Id
          BG002
          spread
          13.2
          value
          51.2
        4. group Id
          BG003
          spread
          13.6
          value
          53.8
        5. group Id
          BG004
          spread
          11.0
          value
          60.6
        6. group Id
          BG005
          spread
          17.8
          value
          49.2
        7. group Id
          BG006
          spread
          9.1
          value
          59.5
        8. group Id
          BG007
          spread
          11.09
          value
          63.0
        9. group Id
          BG008
          spread
          18.25
          value
          61.8
        10. group Id
          BG009
          spread
          12.6
          value
          57.7
        11. group Id
          BG010
          spread
          12.8
          value
          57.5
    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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          257
        11. group Id
          BG010
          value
          283
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          271
        11. group Id
          BG010
          value
          307
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          19
        11. group Id
          BG010
          value
          28
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          465
        11. group Id
          BG010
          value
          516
        title
        Not Hispanic or Latino
      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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          44
        11. group Id
          BG010
          value
          46
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          203
        11. group Id
          BG010
          value
          209
      title
      Asian
    2. 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
          2
        11. group Id
          BG010
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          6
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          284
        11. group Id
          BG010
          value
          331
      title
      White
    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
          3
        11. group Id
          BG010
          value
          3
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        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
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          32
        11. group Id
          BG010
          value
          39
      title
      Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety population included all participants who had received at least 1 dose of the study drug regardless of the starting dose levels.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice