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NCT03037385 · FLOW

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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.

groups
  1. description
    Participants received pralsetinib 30 milligrams (mg), orally, once a day (QD) until discontinuation due to toxicity, disease progression, or other reasons.
    id
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    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
    FG008
    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
    FG009
    title
    Phase II: Pralsetinib 400 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        240
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      type
      Initiation of Another Therapy
    4. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        16
      type
      Lost to Follow-up
    5. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Physician Decision
    6. 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
        5
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        30
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        52
      type
      Withdrawal by Subject
    8. 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
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        181
      type
      Reason Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        13
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        528
      type
      STARTED
    2. 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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        13
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        528
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For Phase I, The number of participants in each arm within the participant flow reflects the arms they were originally assigned to, whereas numbers reported in the pharmacokinetics outcome measure (OM) represent the number based on actual treatment received by the participants. 1 participant assigned to the 200/100 mg arm received the 100/100 mg treatment. Hence, was counted under the 100/100 mg arm in the PK-evaluable population.
recruitment Details
A total of 590 participants with rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), RET mutation-positive medullary thyroid cancer (also known as RET-mutant MTC), RET fusion-positive thyroid cancer (TC) and other advanced solid tumors took part in the study at 74 investigative sites across 13 countries from 17 March 2017 to 21 March 2024. The study was divided into two parts: Phase 1 (Dose Escalation) and Phase 2 (Dose Expansion).
Complete source fields
groups
  1. description
    Participants received pralsetinib 30 milligrams (mg), orally, once a day (QD) until discontinuation due to toxicity, disease progression, or other reasons.
    id
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    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
    FG008
    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
    FG009
    title
    Phase II: Pralsetinib 400 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        240
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      type
      Initiation of Another Therapy
    4. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        16
      type
      Lost to Follow-up
    5. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Physician Decision
    6. 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
        5
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        30
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        52
      type
      Withdrawal by Subject
    8. 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
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        181
      type
      Reason Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        13
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        528
      type
      STARTED
    2. 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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        13
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        528
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For Phase I, The number of participants in each arm within the participant flow reflects the arms they were originally assigned to, whereas numbers reported in the pharmacokinetics outcome measure (OM) represent the number based on actual treatment received by the participants. 1 participant assigned to the 200/100 mg arm received the 100/100 mg treatment. Hence, was counted under the 100/100 mg arm in the PK-evaluable population.
recruitment Details
A total of 590 participants with rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), RET mutation-positive medullary thyroid cancer (also known as RET-mutant MTC), RET fusion-positive thyroid cancer (TC) and other advanced solid tumors took part in the study at 74 investigative sites across 13 countries from 17 March 2017 to 21 March 2024. The study was divided into two parts: Phase 1 (Dose Escalation) and Phase 2 (Dose Expansion).

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