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NCT04209465 · BASELINE

Baseline characteristics

A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. · Source last updated 2025-04-17

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
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      18
    7. group Id
      BG006
      value
      13
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      6
    10. group Id
      BG009
      value
      4
    11. group Id
      BG010
      value
      6
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Patients who received doses at 25 mg once daily under fasted conditions.
    id
    BG000
    title
    Dose Escalation 25 mg QD
  2. description
    Patients who received doses at 50 mg once daily under fasted conditions.
    id
    BG001
    title
    Dose Escalation 50 mg QD
  3. description
    Patients who received doses at 100 mg once daily under fasted conditions.
    id
    BG002
    title
    Dose Escalation 100 mg QD
  4. description
    Patients who received doses at 200 mg once daily under fasted conditions.
    id
    BG003
    title
    Dose Escalation 200 mg QD
  5. description
    Patients who received 400 mg once daily under fasted conditions.
    id
    BG004
    title
    Dose Escalation 400 mg QD
  6. description
    Patients who received 800 mg once daily under fasted conditions.
    id
    BG005
    title
    Dose Escalation 800 mg QD
  7. description
    Patients who received 800 mg once daily under not fasted conditions.
    id
    BG006
    title
    Dose Escalation 800 mg QD NF
  8. description
    Patients who received 1000 mg once daily under not fasted conditions
    id
    BG007
    title
    Dose Escalation 1000 mg QD
  9. description
    Patients who received 1200 mg once daily under fasted conditions.
    id
    BG008
    title
    Dose Escalation 1200 mg QD
  10. description
    Patients who received 400 mg twice daily under not fasted conditions.
    id
    BG009
    title
    Dose Escalation 400 mg BID
  11. description
    Patients who received 600 mg twice daily under not fasted conditions.
    id
    BG010
    title
    Dose Escalation 600 mg BID
  12. description
    Patients who received 800 mg twice daily under fasted conditions.
    id
    BG011
    title
    Dose Escalation 800 mg BID
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
        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
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          5
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          0
        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
          value
          56
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          spread
          17.0
          value
          60
        5. group Id
          BG004
          spread
          9.48
          value
          64.5
        6. group Id
          BG005
          spread
          11.94
          value
          65.4
        7. group Id
          BG006
          spread
          7.00
          value
          60.2
        8. group Id
          BG007
          spread
          7.00
          value
          61.4
        9. group Id
          BG008
          spread
          6.59
          value
          55.8
        10. group Id
          BG009
          spread
          6.06
          value
          71.0
        11. group Id
          BG010
          spread
          11.99
          value
          59.3
        12. group Id
          BG011
          spread
          5.70
          value
          58.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          2
        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
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          15
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          5
        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
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          5
      title
      United States
    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
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      18
    7. group Id
      BG006
      value
      13
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      6
    10. group Id
      BG009
      value
      4
    11. group Id
      BG010
      value
      6
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Patients who received doses at 25 mg once daily under fasted conditions.
    id
    BG000
    title
    Dose Escalation 25 mg QD
  2. description
    Patients who received doses at 50 mg once daily under fasted conditions.
    id
    BG001
    title
    Dose Escalation 50 mg QD
  3. description
    Patients who received doses at 100 mg once daily under fasted conditions.
    id
    BG002
    title
    Dose Escalation 100 mg QD
  4. description
    Patients who received doses at 200 mg once daily under fasted conditions.
    id
    BG003
    title
    Dose Escalation 200 mg QD
  5. description
    Patients who received 400 mg once daily under fasted conditions.
    id
    BG004
    title
    Dose Escalation 400 mg QD
  6. description
    Patients who received 800 mg once daily under fasted conditions.
    id
    BG005
    title
    Dose Escalation 800 mg QD
  7. description
    Patients who received 800 mg once daily under not fasted conditions.
    id
    BG006
    title
    Dose Escalation 800 mg QD NF
  8. description
    Patients who received 1000 mg once daily under not fasted conditions
    id
    BG007
    title
    Dose Escalation 1000 mg QD
  9. description
    Patients who received 1200 mg once daily under fasted conditions.
    id
    BG008
    title
    Dose Escalation 1200 mg QD
  10. description
    Patients who received 400 mg twice daily under not fasted conditions.
    id
    BG009
    title
    Dose Escalation 400 mg BID
  11. description
    Patients who received 600 mg twice daily under not fasted conditions.
    id
    BG010
    title
    Dose Escalation 600 mg BID
  12. description
    Patients who received 800 mg twice daily under fasted conditions.
    id
    BG011
    title
    Dose Escalation 800 mg BID
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
        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
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          5
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          0
        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
          value
          56
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          spread
          17.0
          value
          60
        5. group Id
          BG004
          spread
          9.48
          value
          64.5
        6. group Id
          BG005
          spread
          11.94
          value
          65.4
        7. group Id
          BG006
          spread
          7.00
          value
          60.2
        8. group Id
          BG007
          spread
          7.00
          value
          61.4
        9. group Id
          BG008
          spread
          6.59
          value
          55.8
        10. group Id
          BG009
          spread
          6.06
          value
          71.0
        11. group Id
          BG010
          spread
          11.99
          value
          59.3
        12. group Id
          BG011
          spread
          5.70
          value
          58.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          2
        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
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          15
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          5
        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
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          5
      title
      United States
    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
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice