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NCT00585195 · BASELINE

Baseline characteristics

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer · Source last updated 2023-02-08

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
      4
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      7
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      6
    8. group Id
      BG007
      value
      5
    9. group Id
      BG008
      value
      3
    10. group Id
      BG009
      value
      6
    11. group Id
      BG010
      value
      9
    12. group Id
      BG011
      value
      53
    units
    Participants
groups
  1. description
    Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
    id
    BG000
    title
    Low Dose Escalation Cohort: Crizotinib 50 mg QD
  2. description
    Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
    id
    BG001
    title
    Low Dose Escalation Cohort: Crizotinib 100 mg QD
  3. description
    Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
    id
    BG002
    title
    Low Dose Escalation Cohort: Crizotinib 200 mg QD
  4. description
    Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
    id
    BG003
    title
    Low Dose Escalation Cohort: Crizotinib 200 mg BID
  5. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
    id
    BG004
    title
    Low Dose Escalation Cohort: Crizotinib 250 mg BID
  6. description
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
    id
    BG005
    title
    Low Dose Escalation Cohort: Crizotinib 300 mg BID
  7. description
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    BG006
    title
    High Dose Escalation Cohort: Crizotinib 300 mg QD
  8. description
    Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    BG007
    title
    High Dose Escalation Cohort: Crizotinib 400 mg QD
  9. description
    Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    BG008
    title
    High Dose Escalation Cohort: Crizotinib 500 mg QD
  10. description
    Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
    id
    BG009
    title
    High Dose Escalation Cohort: Crizotinib 650 mg QD
  11. description
    Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    BG010
    title
    High Dose Escalation Cohort: Crizotinib 800 mg QD
  12. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).
    id
    BG011
    title
    RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          23
      title
      less than 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          30
      title
      greater than or equals to 65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          23
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          30
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        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
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          21
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        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
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      7
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      6
    8. group Id
      BG007
      value
      5
    9. group Id
      BG008
      value
      3
    10. group Id
      BG009
      value
      6
    11. group Id
      BG010
      value
      9
    12. group Id
      BG011
      value
      53
    units
    Participants
groups
  1. description
    Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
    id
    BG000
    title
    Low Dose Escalation Cohort: Crizotinib 50 mg QD
  2. description
    Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
    id
    BG001
    title
    Low Dose Escalation Cohort: Crizotinib 100 mg QD
  3. description
    Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
    id
    BG002
    title
    Low Dose Escalation Cohort: Crizotinib 200 mg QD
  4. description
    Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
    id
    BG003
    title
    Low Dose Escalation Cohort: Crizotinib 200 mg BID
  5. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
    id
    BG004
    title
    Low Dose Escalation Cohort: Crizotinib 250 mg BID
  6. description
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
    id
    BG005
    title
    Low Dose Escalation Cohort: Crizotinib 300 mg BID
  7. description
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    BG006
    title
    High Dose Escalation Cohort: Crizotinib 300 mg QD
  8. description
    Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    BG007
    title
    High Dose Escalation Cohort: Crizotinib 400 mg QD
  9. description
    Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    BG008
    title
    High Dose Escalation Cohort: Crizotinib 500 mg QD
  10. description
    Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
    id
    BG009
    title
    High Dose Escalation Cohort: Crizotinib 650 mg QD
  11. description
    Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    BG010
    title
    High Dose Escalation Cohort: Crizotinib 800 mg QD
  12. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).
    id
    BG011
    title
    RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          23
      title
      less than 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          30
      title
      greater than or equals to 65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          23
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          30
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        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
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          21
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        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
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice