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NCT03899792 · BASELINE

Baseline characteristics

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors · Source last updated 2026-01-06

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
      3
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      15
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      36
    units
    Participants
groups
  1. description
    Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m\^2 (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
    id
    BG000
    title
    Dose Escalation Cohort (Phase 1)
  2. description
    Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    BG001
    title
    Cohort 1 (Phase 2): MTC Group
  3. description
    Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    BG002
    title
    Cohort 2 (Phase 2): PTC Group
  4. description
    Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    BG003
    title
    Cohort 3 (Phase 2): Other Cancer Group
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          30
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
        title
        Between 18 and 65 years
      title
      Age
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          26
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    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
          7
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          10
        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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          18
        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
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. 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
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
      title
      South Korea
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          11
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
      title
      Japan
    5. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Denmark
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      Italy
    7. 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
          0
        5. group Id
          BG004
          value
          1
      title
      France
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
      title
      Australia
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      Germany
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All participants who received at least one dose of study drug. The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      15
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      36
    units
    Participants
groups
  1. description
    Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m\^2 (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
    id
    BG000
    title
    Dose Escalation Cohort (Phase 1)
  2. description
    Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    BG001
    title
    Cohort 1 (Phase 2): MTC Group
  3. description
    Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    BG002
    title
    Cohort 2 (Phase 2): PTC Group
  4. description
    Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    BG003
    title
    Cohort 3 (Phase 2): Other Cancer Group
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          30
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
        title
        Between 18 and 65 years
      title
      Age
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          26
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    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
          7
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          10
        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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          18
        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
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. 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
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
      title
      South Korea
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          11
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
      title
      Japan
    5. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Denmark
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      Italy
    7. 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
          0
        5. group Id
          BG004
          value
          1
      title
      France
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
      title
      Australia
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      Germany
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All participants who received at least one dose of study drug. The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.

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Preserved source evidence · Not medical advice