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NCT03899792 · FLOW

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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.

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 BID (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
    id
    FG000
    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
    FG001
    title
    Cohort 1 (Phase 2): Medullary Thyroid Cancer (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
    FG002
    title
    Cohort 2 (Phase 2): Papillary Thyroid Cancer (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
    FG003
    title
    Cohort 3 (Phase 2): Other Cancer Group
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        2
      type
      Ongoing Treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Out of 15 participants, 2 participants transitioned from Phase 1.
        group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        15
      4. comment
        Out of 6 participants, 1 participant transitioned from Phase 1.
        group Id
        FG003
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        6
      type
      Received At Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Phase 2
pre Assignment Details
In Phase 2, participants were assigned to one of three disease-based groups: medullary thyroid cancer (MTC), papillary thyroid cancer (PTC), or Other Solid Tumors and received selpercatinib at the RP2D. Current primary results are reported, and additional results will be reported during study completion.
recruitment Details
The study consisted of two parts: Phase 1 (dose-escalation) and Phase 2 (dose-expansion). In Phase 1, three participants received selpercatinib, with dosing based on body surface area. The starting dose level was 92 mg/m\^2 (maximum 160 mg, twice daily (BID\]), selected to approximate the exposure associated with the recommended Phase 2 dose (RP2D) in adults. The Phase 2 portion opened for enrollment after confirmation of the RP2D of 92 mg/m\^2 (maximum 160 mg BID).
Complete source fields
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 BID (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
    id
    FG000
    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
    FG001
    title
    Cohort 1 (Phase 2): Medullary Thyroid Cancer (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
    FG002
    title
    Cohort 2 (Phase 2): Papillary Thyroid Cancer (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
    FG003
    title
    Cohort 3 (Phase 2): Other Cancer Group
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        2
      type
      Ongoing Treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Out of 15 participants, 2 participants transitioned from Phase 1.
        group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        15
      4. comment
        Out of 6 participants, 1 participant transitioned from Phase 1.
        group Id
        FG003
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        6
      type
      Received At Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Phase 2
pre Assignment Details
In Phase 2, participants were assigned to one of three disease-based groups: medullary thyroid cancer (MTC), papillary thyroid cancer (PTC), or Other Solid Tumors and received selpercatinib at the RP2D. Current primary results are reported, and additional results will be reported during study completion.
recruitment Details
The study consisted of two parts: Phase 1 (dose-escalation) and Phase 2 (dose-expansion). In Phase 1, three participants received selpercatinib, with dosing based on body surface area. The starting dose level was 92 mg/m\^2 (maximum 160 mg, twice daily (BID\]), selected to approximate the exposure associated with the recommended Phase 2 dose (RP2D) in adults. The Phase 2 portion opened for enrollment after confirmation of the RP2D of 92 mg/m\^2 (maximum 160 mg BID).

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Preserved source evidence · Not medical advice