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NCT00819169 · BASELINE

Baseline characteristics

QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors · Source last updated 2024-08-20

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

denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      15
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      16
    7. group Id
      BG006
      value
      16
    8. group Id
      BG007
      value
      9
    9. group Id
      BG008
      value
      16
    10. group Id
      BG009
      value
      89
    units
    Participants
groups
  1. description
    AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    BG000
    title
    Part 1 Cohort 1
  2. description
    AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    BG001
    title
    Part 1 Cohort 2
  3. description
    AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    BG002
    title
    Part 1 Cohort 3
  4. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
    id
    BG003
    title
    Part 2 Cohort 1
  5. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC
    id
    BG004
    title
    Part 2 Cohort 2
  6. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC
    id
    BG005
    title
    Part 2 Cohort 3
  7. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
    id
    BG006
    title
    Part 2 Cohort 4
  8. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
    id
    BG007
    title
    Part 2 Cohort 5
  9. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
    id
    BG008
    title
    Part 2 Cohort 6
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.9
          value
          48.0
        2. group Id
          BG001
          spread
          1.2
          value
          65.3
        3. group Id
          BG002
          spread
          4.4
          value
          46.0
        4. group Id
          BG009
          spread
          14.1
          value
          53.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          9
        units
        Participants
      title
      Part 1
    2. categories
      1. measurements
        1. group Id
          BG003
          spread
          10.3
          value
          61.0
        2. group Id
          BG004
          spread
          7.3
          value
          67.0
        3. group Id
          BG005
          spread
          11.0
          value
          59.1
        4. group Id
          BG006
          spread
          8.8
          value
          60.2
        5. group Id
          BG007
          spread
          15.8
          value
          58.0
        6. group Id
          BG008
          spread
          9.8
          value
          51.3
        7. group Id
          BG009
          spread
          11.1
          value
          58.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          80
        units
        Participants
      title
      Part 2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Part 1 and Part 2 were analyzed separately.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          44
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          43
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          15
        10. group Id
          BG009
          value
          87
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    For part 2 the full analysis population was used which included only those subjects that received investigational product.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          73
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          15
        10. group Id
          BG009
          value
          87
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    For part 2 the full analysis population was used which included only those subjects that received investigational product.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      15
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      16
    7. group Id
      BG006
      value
      16
    8. group Id
      BG007
      value
      9
    9. group Id
      BG008
      value
      16
    10. group Id
      BG009
      value
      89
    units
    Participants
groups
  1. description
    AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    BG000
    title
    Part 1 Cohort 1
  2. description
    AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    BG001
    title
    Part 1 Cohort 2
  3. description
    AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    BG002
    title
    Part 1 Cohort 3
  4. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
    id
    BG003
    title
    Part 2 Cohort 1
  5. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC
    id
    BG004
    title
    Part 2 Cohort 2
  6. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC
    id
    BG005
    title
    Part 2 Cohort 3
  7. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
    id
    BG006
    title
    Part 2 Cohort 4
  8. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
    id
    BG007
    title
    Part 2 Cohort 5
  9. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
    id
    BG008
    title
    Part 2 Cohort 6
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.9
          value
          48.0
        2. group Id
          BG001
          spread
          1.2
          value
          65.3
        3. group Id
          BG002
          spread
          4.4
          value
          46.0
        4. group Id
          BG009
          spread
          14.1
          value
          53.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          9
        units
        Participants
      title
      Part 1
    2. categories
      1. measurements
        1. group Id
          BG003
          spread
          10.3
          value
          61.0
        2. group Id
          BG004
          spread
          7.3
          value
          67.0
        3. group Id
          BG005
          spread
          11.0
          value
          59.1
        4. group Id
          BG006
          spread
          8.8
          value
          60.2
        5. group Id
          BG007
          spread
          15.8
          value
          58.0
        6. group Id
          BG008
          spread
          9.8
          value
          51.3
        7. group Id
          BG009
          spread
          11.1
          value
          58.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          80
        units
        Participants
      title
      Part 2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Part 1 and Part 2 were analyzed separately.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          44
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          43
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          15
        10. group Id
          BG009
          value
          87
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    For part 2 the full analysis population was used which included only those subjects that received investigational product.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          73
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          15
        10. group Id
          BG009
          value
          87
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    For part 2 the full analysis population was used which included only those subjects that received investigational product.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice