Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00939627 · BASELINE

Baseline characteristics

Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab · Source last updated 2026-03-10

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
      27
    2. group Id
      BG001
      value
      28
    3. group Id
      BG002
      value
      55
    units
    Participants
groups
  1. description
    Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
    id
    BG000
    title
    Arm A - Cetuximab
  2. description
    Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
    id
    BG001
    title
    Arm B - Cetuximab and Sorafenib Tosylate
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          41
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        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
          lower Limit
          26
          upper Limit
          74
          value
          59
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          71
          value
          60
        3. group Id
          BG002
          lower Limit
          26
          upper Limit
          74
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          48
        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
          27
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          55
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Baseline participant measures are based on total eligible, consented, patients. Three of 55 consenting patients did not receive treatment. One patient had disease progression before treatment and 2 patients withdrew before treatment, resulting in 52 patients on treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      27
    2. group Id
      BG001
      value
      28
    3. group Id
      BG002
      value
      55
    units
    Participants
groups
  1. description
    Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
    id
    BG000
    title
    Arm A - Cetuximab
  2. description
    Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
    id
    BG001
    title
    Arm B - Cetuximab and Sorafenib Tosylate
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          41
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        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
          lower Limit
          26
          upper Limit
          74
          value
          59
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          71
          value
          60
        3. group Id
          BG002
          lower Limit
          26
          upper Limit
          74
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          48
        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
          27
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          55
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Baseline participant measures are based on total eligible, consented, patients. Three of 55 consenting patients did not receive treatment. One patient had disease progression before treatment and 2 patients withdrew before treatment, resulting in 52 patients on treatment.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice