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NCT02494570 · BASELINE

Baseline characteristics

A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa · Source last updated 2023-04-07

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
      34
    units
    Participants
groups
  1. description
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.
    id
    BG000
    title
    Experimental: Nab-Sirolimus
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          78
          value
          60
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
      title
      0 (Fully active, able to carry on all pre-disease performance without restriction)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
      title
      1 (Restricted in physically strenuous activity but ambulatory and able to carry out light work)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Score
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    For the assessment of overall tumor burden and measurable advanced disease (metastatic or locally advanced) at baseline, computed tomography (CT) or contrast enhanced magnetic resonance imaging (MRI) could be used, as long as the same modality was used throughout the study. Baseline scans were done at done within 4 weeks of starting therapy and must have included (as clinically indicated), chest, abdominal, and pelvic CT or MRI.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Metastatic PEComa
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    For the assessment of overall tumor burden and measurable advanced disease (metastatic or locally advanced) at baseline, computed tomography (CT) or contrast enhanced magnetic resonance imaging (MRI) could be used, as long as the same modality was used throughout the study. Baseline scans were done at done within 4 weeks of starting therapy and must have included (as clinically indicated), chest, abdominal, and pelvic CT or MRI.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Locally Advanced, Inoperable PEComa
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Systemic Therapy for Advanced PEComa
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        Uterus
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Pelvis, extrauterine
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        Retroperitoneum
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Lung
      5. measurements
        1. group Id
          BG000
          value
          4
        title
        Kidney
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Aorta
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Brain
      8. measurements
        1. group Id
          BG000
          value
          1
        title
        Liver
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        Muscle
      10. measurements
        1. group Id
          BG000
          value
          1
        title
        Ovary
      11. measurements
        1. group Id
          BG000
          value
          1
        title
        Small Bowel
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    PEComa can be located at various anatomic sites.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Location of PEComa
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        1 metastatic site (best)
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        2 metastatic sites
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        3 metastatic sites
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        >3 metastatic sites (worst)
      denoms
      1. counts
        1. group Id
          BG000
          value
          29
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients with metastatic lesions n = 29.
    title
    Number of Metastatic Sites
    unit Of Measure
    Participants
population Description
Safety Analysis Set: patients treated with nab-sirolimus (N = 34)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      34
    units
    Participants
groups
  1. description
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.
    id
    BG000
    title
    Experimental: Nab-Sirolimus
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          78
          value
          60
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
      title
      0 (Fully active, able to carry on all pre-disease performance without restriction)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
      title
      1 (Restricted in physically strenuous activity but ambulatory and able to carry out light work)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Score
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    For the assessment of overall tumor burden and measurable advanced disease (metastatic or locally advanced) at baseline, computed tomography (CT) or contrast enhanced magnetic resonance imaging (MRI) could be used, as long as the same modality was used throughout the study. Baseline scans were done at done within 4 weeks of starting therapy and must have included (as clinically indicated), chest, abdominal, and pelvic CT or MRI.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Metastatic PEComa
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    For the assessment of overall tumor burden and measurable advanced disease (metastatic or locally advanced) at baseline, computed tomography (CT) or contrast enhanced magnetic resonance imaging (MRI) could be used, as long as the same modality was used throughout the study. Baseline scans were done at done within 4 weeks of starting therapy and must have included (as clinically indicated), chest, abdominal, and pelvic CT or MRI.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Locally Advanced, Inoperable PEComa
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Systemic Therapy for Advanced PEComa
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        Uterus
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Pelvis, extrauterine
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        Retroperitoneum
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Lung
      5. measurements
        1. group Id
          BG000
          value
          4
        title
        Kidney
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Aorta
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Brain
      8. measurements
        1. group Id
          BG000
          value
          1
        title
        Liver
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        Muscle
      10. measurements
        1. group Id
          BG000
          value
          1
        title
        Ovary
      11. measurements
        1. group Id
          BG000
          value
          1
        title
        Small Bowel
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    PEComa can be located at various anatomic sites.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Location of PEComa
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        1 metastatic site (best)
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        2 metastatic sites
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        3 metastatic sites
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        >3 metastatic sites (worst)
      denoms
      1. counts
        1. group Id
          BG000
          value
          29
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients with metastatic lesions n = 29.
    title
    Number of Metastatic Sites
    unit Of Measure
    Participants
population Description
Safety Analysis Set: patients treated with nab-sirolimus (N = 34)

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Preserved source evidence · Not medical advice