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NCT02014116 · FLOW

Participant flow

A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body · Source last updated 2019-12-27

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

groups
  1. description
    50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG000
    title
    Cohort 1
  2. description
    100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG001
    title
    Cohort 2
  3. description
    200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG002
    title
    Cohort 3
  4. description
    400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG003
    title
    Cohort 4
  5. description
    500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG004
    title
    Cohort 5
  6. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG005
    title
    Cohort 6
  7. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase
    id
    FG006
    title
    Cohort A
  8. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase
    id
    FG007
    title
    Cohort B
  9. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose confirmation Phase
    id
    FG008
    title
    Cohort C
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        13
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        7
      type
      Progressive Disease
    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
        0
      5. group Id
        FG004
        num Subjects
        1
      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
      type
      Adverse Event
    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
        1
      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
        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
        1
      type
      Death
    5. 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
        1
      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
      type
      Withdrawal by Subject
    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
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Withdrawal Caregiver Decision
    7. 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
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        10
      type
      Received at Least One 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
      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
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of two parts: Part A, a dose escalation phase to determine recommend Phase 2 dose. During Part A, safety data will be assessed and used as primary criteria for dose escalation. Part B, a tumor-specific expansion of treatment groups (cohorts) for dose confirmation.
Complete source fields
groups
  1. description
    50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG000
    title
    Cohort 1
  2. description
    100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG001
    title
    Cohort 2
  3. description
    200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG002
    title
    Cohort 3
  4. description
    400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG003
    title
    Cohort 4
  5. description
    500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG004
    title
    Cohort 5
  6. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase
    id
    FG005
    title
    Cohort 6
  7. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase
    id
    FG006
    title
    Cohort A
  8. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase
    id
    FG007
    title
    Cohort B
  9. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose confirmation Phase
    id
    FG008
    title
    Cohort C
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        13
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        7
      type
      Progressive Disease
    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
        0
      5. group Id
        FG004
        num Subjects
        1
      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
      type
      Adverse Event
    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
        1
      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
        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
        1
      type
      Death
    5. 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
        1
      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
      type
      Withdrawal by Subject
    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
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Withdrawal Caregiver Decision
    7. 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
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        10
      type
      Received at Least One 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
      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
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of two parts: Part A, a dose escalation phase to determine recommend Phase 2 dose. During Part A, safety data will be assessed and used as primary criteria for dose escalation. Part B, a tumor-specific expansion of treatment groups (cohorts) for dose confirmation.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice