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NCT02431260 · FLOW

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An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies · Source last updated 2019-06-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG000
    title
    Part 1 / Treatment Group A: 15 MG QD INCB054329
  2. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG001
    title
    Part 1 / Treatment Group A: 22.5 MG QD INCB054329
  3. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG002
    title
    Part 1 / Treatment Group A: 15 MG BID INCB054329
  4. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG003
    title
    Part 1 / Treatment Group A: 30 MG QD INCB054329
  5. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG004
    title
    Part 1 / Treatment Group A: 22.5 MG BID INCB054329
  6. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG005
    title
    Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
  7. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG006
    title
    Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
  8. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG007
    title
    Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
  9. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG008
    title
    Part 1 / Treatment Group A: 20 MG BID INCB054329
  10. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG009
    title
    Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
  11. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG010
    title
    Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
  12. description
    Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
    id
    FG011
    title
    Part 1 / Treatment Group B: 20 MG BID INCB054329
periods
  1. drop Withdraws
    1. 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
      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
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      Subject Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        6
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        2
      type
      Death
    3. 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
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      12. group Id
        FG011
        num Subjects
        0
      type
      Study Terminated by the Sponsor
    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
        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
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Physician Decision
    6. 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
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      Other Unspecified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        8
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        4
      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
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        8
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG000
    title
    Part 1 / Treatment Group A: 15 MG QD INCB054329
  2. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG001
    title
    Part 1 / Treatment Group A: 22.5 MG QD INCB054329
  3. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG002
    title
    Part 1 / Treatment Group A: 15 MG BID INCB054329
  4. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG003
    title
    Part 1 / Treatment Group A: 30 MG QD INCB054329
  5. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG004
    title
    Part 1 / Treatment Group A: 22.5 MG BID INCB054329
  6. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG005
    title
    Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
  7. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG006
    title
    Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
  8. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG007
    title
    Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
  9. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG008
    title
    Part 1 / Treatment Group A: 20 MG BID INCB054329
  10. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG009
    title
    Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
  11. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    FG010
    title
    Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
  12. description
    Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
    id
    FG011
    title
    Part 1 / Treatment Group B: 20 MG BID INCB054329
periods
  1. drop Withdraws
    1. 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
      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
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      Subject Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        6
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        2
      type
      Death
    3. 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
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      12. group Id
        FG011
        num Subjects
        0
      type
      Study Terminated by the Sponsor
    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
        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
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Physician Decision
    6. 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
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      Other Unspecified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        8
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        4
      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
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        8
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study

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