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PF-06671008 Dose Escalation Study in Advanced Solid Tumors · Source last updated 2020-05-06

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

groups
  1. description
    PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 nanogram/kilogram (ng/kg). PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG000
    title
    PF-06671008 1.5 ng/kg IV
  2. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
    id
    FG001
    title
    PF-06671008 7.5 ng/kg IV
  3. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG002
    title
    PF-06671008 20 ng/kg IV
  4. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    FG003
    title
    PF-06671008 50 ng/kg IV
  5. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG004
    title
    PF-06671008 100 ng/kg IV
  6. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
    id
    FG005
    title
    PF-06671008 200 ng/kg IV
  7. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG006
    title
    PF-06671008 300 ng/kg IV
  8. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    FG007
    title
    PF-06671008 400 ng/kg IV
  9. description
    PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
    id
    FG008
    title
    PF-06671008 200 ng/kg SC
  10. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG009
    title
    PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
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
        2
      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
      type
      Lost to Follow-up
    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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal prior to treatment
    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
        1
      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
        0
      type
      Participant refused further follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Death (follow-up phase)
    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
        1
      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
        0
      type
      Death (treatment phase)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      comment
      This study was terminated early and Part 2 was not initiated. The form only includes arms in Part 1.
      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
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Twenty-eight (28) participants were enrolled and 27 participants received study drug. One participant discontinued before receiving treatment.
Complete source fields
groups
  1. description
    PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 nanogram/kilogram (ng/kg). PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG000
    title
    PF-06671008 1.5 ng/kg IV
  2. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
    id
    FG001
    title
    PF-06671008 7.5 ng/kg IV
  3. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG002
    title
    PF-06671008 20 ng/kg IV
  4. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    FG003
    title
    PF-06671008 50 ng/kg IV
  5. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG004
    title
    PF-06671008 100 ng/kg IV
  6. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
    id
    FG005
    title
    PF-06671008 200 ng/kg IV
  7. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG006
    title
    PF-06671008 300 ng/kg IV
  8. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    FG007
    title
    PF-06671008 400 ng/kg IV
  9. description
    PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
    id
    FG008
    title
    PF-06671008 200 ng/kg SC
  10. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    FG009
    title
    PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
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
        2
      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
      type
      Lost to Follow-up
    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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal prior to treatment
    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
        1
      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
        0
      type
      Participant refused further follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Death (follow-up phase)
    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
        1
      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
        0
      type
      Death (treatment phase)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      comment
      This study was terminated early and Part 2 was not initiated. The form only includes arms in Part 1.
      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
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Twenty-eight (28) participants were enrolled and 27 participants received study drug. One participant discontinued before receiving treatment.

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Preserved source evidence · Not medical advice