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NCT02101788 · BASELINE

Baseline characteristics

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer · Source last updated 2026-08-04

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
      130
    2. group Id
      BG001
      value
      130
    3. group Id
      BG002
      value
      260
    units
    Participants
groups
  1. description
    Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
    id
    BG000
    title
    Arm A - Control Arm
  2. description
    Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
    id
    BG001
    title
    Arm B - Experimental Arm
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.03
          value
          53.89
        2. group Id
          BG001
          spread
          14.13
          value
          53.57
        3. group Id
          BG002
          spread
          14.1
          value
          53.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      20-29 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          34
      title
      30-39 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          43
      title
      40-49 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          63
      title
      50-59 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          72
      title
      60-69 years
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          29
      title
      >= 70 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          130
        3. group Id
          BG002
          value
          260
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          236
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          229
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        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
          102
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          205
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          55
      title
      United Kingdom
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          59
      title
      1 Prior Treatment Regimens
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          76
      title
      2 Prior Treatment Regimens
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
      title
      3 or More Prior Treatment Regimens
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Treatment Regimens
    unit Of Measure
    Participants
population Description
All enrolled patients.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      130
    2. group Id
      BG001
      value
      130
    3. group Id
      BG002
      value
      260
    units
    Participants
groups
  1. description
    Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
    id
    BG000
    title
    Arm A - Control Arm
  2. description
    Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
    id
    BG001
    title
    Arm B - Experimental Arm
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.03
          value
          53.89
        2. group Id
          BG001
          spread
          14.13
          value
          53.57
        3. group Id
          BG002
          spread
          14.1
          value
          53.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      20-29 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          34
      title
      30-39 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          43
      title
      40-49 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          63
      title
      50-59 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          72
      title
      60-69 years
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          29
      title
      >= 70 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          130
        3. group Id
          BG002
          value
          260
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          236
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          229
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        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
          102
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          205
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          55
      title
      United Kingdom
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          59
      title
      1 Prior Treatment Regimens
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          76
      title
      2 Prior Treatment Regimens
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
      title
      3 or More Prior Treatment Regimens
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Treatment Regimens
    unit Of Measure
    Participants
population Description
All enrolled patients.

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

Preserved source evidence · Not medical advice