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NCT05185947 · BASELINE

Baseline characteristics

Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis · Source last updated 2026-06-25

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
      7
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      21
    units
    Participants
groups
  1. description
    Participants were enrolled, assigned to Arm/Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m\^2 then 80mg/m\^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m\^2 then Cycles 4-6 80mg/m\^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID). Participants enrolled, assigned to an Arm/Cohort, and start protocol treatment.
    id
    BG000
    title
    Participants Enrolled, Assigned to Cohort 1/Arm 1 Peritoneal Carcinomatosis, and Treated
  2. description
    Participants were enrolled, assigned to Arm/(Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m\^2 then 80mg/m\^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m\^2 then Cycles 4-6 80mg/m\^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID)); but opted to come off-study prior to start of protocol treatment.
    id
    BG001
    title
    Participants Enrolled, Assigned to an Arm/Cohort, But Not Treated
  3. description
    Participants were enrolled, were not assigned to an Arm/Cohort, and were not treated.
    id
    BG002
    title
    Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. 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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          15
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.051
          value
          58.000
        2. group Id
          BG001
          spread
          0.707
          value
          46.500
        3. group Id
          BG002
          spread
          10.364
          value
          59.833
        4. group Id
          BG003
          spread
          9.032
          value
          58.095
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. 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
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          16
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        title
        American Indian or Alaska Native
      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
          1
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          14
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          20
      title
      United States
    2. categories
      1. 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
      title
      Canada
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
We report all participants enrolled to the study. As such, baseline data collected for participants enrolled, not assigned to an Arm/Cohort and not treated are reported here.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      21
    units
    Participants
groups
  1. description
    Participants were enrolled, assigned to Arm/Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m\^2 then 80mg/m\^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m\^2 then Cycles 4-6 80mg/m\^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID). Participants enrolled, assigned to an Arm/Cohort, and start protocol treatment.
    id
    BG000
    title
    Participants Enrolled, Assigned to Cohort 1/Arm 1 Peritoneal Carcinomatosis, and Treated
  2. description
    Participants were enrolled, assigned to Arm/(Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m\^2 then 80mg/m\^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m\^2 then Cycles 4-6 80mg/m\^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID)); but opted to come off-study prior to start of protocol treatment.
    id
    BG001
    title
    Participants Enrolled, Assigned to an Arm/Cohort, But Not Treated
  3. description
    Participants were enrolled, were not assigned to an Arm/Cohort, and were not treated.
    id
    BG002
    title
    Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. 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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          15
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.051
          value
          58.000
        2. group Id
          BG001
          spread
          0.707
          value
          46.500
        3. group Id
          BG002
          spread
          10.364
          value
          59.833
        4. group Id
          BG003
          spread
          9.032
          value
          58.095
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. 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
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          16
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        title
        American Indian or Alaska Native
      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
          1
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          14
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          20
      title
      United States
    2. categories
      1. 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
      title
      Canada
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
We report all participants enrolled to the study. As such, baseline data collected for participants enrolled, not assigned to an Arm/Cohort and not treated are reported here.

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Preserved source evidence · Not medical advice