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A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13

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

groups
  1. description
    Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
    id
    FG000
    title
    Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
  2. description
    Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
    id
    FG001
    title
    Part 1: PF-06801591 1 mg/kg (IV)
  3. description
    Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
    id
    FG002
    title
    Part 1: PF-06801591 3 mg/kg (IV)
  4. description
    Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
    id
    FG003
    title
    Part 1: PF-06801591 10 mg/kg (IV)
  5. description
    Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
    id
    FG004
    title
    Part 1: PF-06801591 300 mg (Subcutaneously [SC])
  6. description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    FG005
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  7. description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    FG006
    title
    Part 2: PF-06801591 300 mg (SC) for UC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        32
      7. group Id
        FG006
        num Subjects
        21
      type
      Death
    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
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        20
      7. group Id
        FG006
        num Subjects
        7
      type
      Participant refused further 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
        1
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        5
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        15
      6. group Id
        FG005
        num Subjects
        68
      7. group Id
        FG006
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        15
      6. group Id
        FG005
        num Subjects
        68
      7. group Id
        FG006
        num Subjects
        38
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      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
        2
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        5
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        13
      6. group Id
        FG005
        num Subjects
        58
      7. group Id
        FG006
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 147 participants were enrolled in this study, and 146 participants received study treatment. For Part 1, 40 participants were enrolled and treated. For Part 2, 107 participants were enrolled including 68 participants with non small cell lung cancer (NSCLC) and 39 participants with urothelial carcinoma (UC), and 106 participants received study treatment.
Complete source fields
groups
  1. description
    Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
    id
    FG000
    title
    Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
  2. description
    Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
    id
    FG001
    title
    Part 1: PF-06801591 1 mg/kg (IV)
  3. description
    Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
    id
    FG002
    title
    Part 1: PF-06801591 3 mg/kg (IV)
  4. description
    Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
    id
    FG003
    title
    Part 1: PF-06801591 10 mg/kg (IV)
  5. description
    Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
    id
    FG004
    title
    Part 1: PF-06801591 300 mg (Subcutaneously [SC])
  6. description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    FG005
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  7. description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    FG006
    title
    Part 2: PF-06801591 300 mg (SC) for UC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        32
      7. group Id
        FG006
        num Subjects
        21
      type
      Death
    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
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        20
      7. group Id
        FG006
        num Subjects
        7
      type
      Participant refused further 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
        1
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        5
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        15
      6. group Id
        FG005
        num Subjects
        68
      7. group Id
        FG006
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        15
      6. group Id
        FG005
        num Subjects
        68
      7. group Id
        FG006
        num Subjects
        38
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      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
        2
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        5
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        13
      6. group Id
        FG005
        num Subjects
        58
      7. group Id
        FG006
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 147 participants were enrolled in this study, and 146 participants received study treatment. For Part 1, 40 participants were enrolled and treated. For Part 2, 107 participants were enrolled including 68 participants with non small cell lung cancer (NSCLC) and 39 participants with urothelial carcinoma (UC), and 106 participants received study treatment.

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Preserved source evidence · Not medical advice