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NCT02860286 · BASELINE

Baseline characteristics

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma · Source last updated 2021-04-09

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
      13
    2. group Id
      BG001
      value
      61
    3. group Id
      BG002
      value
      74
    units
    Participants
groups
  1. description
    Subjects enrolled in Part 1were to receive a single 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was to be administered at a dose of 800 mg twice daily. PK blood samples were to be collected after administration of a single dose of 800 mg tazemetostat on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Plasma samples were to be analyzed for tazemetostat after each set of 6 subjects completed the PK sampling procedures on Cycle 1 Day 15.
    id
    BG000
    title
    Part 1 (Pharmacokenitc)
  2. description
    In Part 2, subjects with BAP1-deficient relapsed or refractory malignant mesothelioma were to receive orally administered tazemetostat 800 mg twice daily starting on Cycle 1 Day 1. A 2-stage Green-Dahlberg design was utilized with a stopping rule to allow early termination at the end of Stage 1 if there was strong evidence of lack of efficacy based on results from the first 30 treated subjects who completed at least the 12-week assessment, completed the final study visit, or terminated early from the study, whichever was sooner. If early stopping criteria were met, enrollment was to be stopped. To avoid disruptions in the study, enrollment and treatment of subjects were not halted in order to conduct the interim analysis.
    id
    BG001
    title
    Part 2 (Efficacy)
  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
          6
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          43
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          31
        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
          8.58
          value
          64.7
        2. group Id
          BG001
          spread
          10.56
          value
          65.1
        3. group Id
          BG002
          spread
          10.18
          value
          65.0
    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
          3
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          25
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          49
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          49
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          21
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          23
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          37
      title
      United Kingdom
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          14
      title
      France
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          30
        title
        Solid Tumor with 1 prior line of systemic Anticancer Therapy
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          20
        title
        Solid Tumor with 2 prior lines of systemic Anticancer Therapy
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          15
        title
        Solid Tumor with 3 prior lines of systemic Anticancer Therapy
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Solid Tumor with 4 prior lines of systemic Anticancer Therapy
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        title
        Solid Tumor with >=5 prior lines of systemic Anticancer Therapy
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Disease Characteristics and Prior Therapies
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      13
    2. group Id
      BG001
      value
      61
    3. group Id
      BG002
      value
      74
    units
    Participants
groups
  1. description
    Subjects enrolled in Part 1were to receive a single 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was to be administered at a dose of 800 mg twice daily. PK blood samples were to be collected after administration of a single dose of 800 mg tazemetostat on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Plasma samples were to be analyzed for tazemetostat after each set of 6 subjects completed the PK sampling procedures on Cycle 1 Day 15.
    id
    BG000
    title
    Part 1 (Pharmacokenitc)
  2. description
    In Part 2, subjects with BAP1-deficient relapsed or refractory malignant mesothelioma were to receive orally administered tazemetostat 800 mg twice daily starting on Cycle 1 Day 1. A 2-stage Green-Dahlberg design was utilized with a stopping rule to allow early termination at the end of Stage 1 if there was strong evidence of lack of efficacy based on results from the first 30 treated subjects who completed at least the 12-week assessment, completed the final study visit, or terminated early from the study, whichever was sooner. If early stopping criteria were met, enrollment was to be stopped. To avoid disruptions in the study, enrollment and treatment of subjects were not halted in order to conduct the interim analysis.
    id
    BG001
    title
    Part 2 (Efficacy)
  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
          6
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          43
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          31
        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
          8.58
          value
          64.7
        2. group Id
          BG001
          spread
          10.56
          value
          65.1
        3. group Id
          BG002
          spread
          10.18
          value
          65.0
    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
          3
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          25
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          49
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          49
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          21
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          23
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          37
      title
      United Kingdom
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          14
      title
      France
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          30
        title
        Solid Tumor with 1 prior line of systemic Anticancer Therapy
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          20
        title
        Solid Tumor with 2 prior lines of systemic Anticancer Therapy
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          15
        title
        Solid Tumor with 3 prior lines of systemic Anticancer Therapy
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Solid Tumor with 4 prior lines of systemic Anticancer Therapy
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        title
        Solid Tumor with >=5 prior lines of systemic Anticancer Therapy
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Disease Characteristics and Prior Therapies
    unit Of Measure
    Participants

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