Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02601950 · BASELINE

Baseline characteristics

A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma · Source last updated 2025-06-22

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
      32
    2. group Id
      BG001
      value
      33
    3. group Id
      BG002
      value
      32
    4. group Id
      BG003
      value
      14
    5. group Id
      BG004
      value
      62
    6. group Id
      BG005
      value
      69
    7. group Id
      BG006
      value
      18
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      267
    units
    Participants
groups
  1. description
    Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG000
    title
    Rhabdoid Tumors: Cohort 1
  2. description
    Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG001
    title
    Synovial Sarcoma: Cohort 2
  3. description
    Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG002
    title
    Other INI1-negative: Cohort 3
  4. description
    Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG003
    title
    RMC: Cohort 4
  5. description
    Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG004
    title
    ES: Cohort 5
  6. description
    Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG005
    title
    ES Paired Biopsy: Cohort 6
  7. description
    Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG006
    title
    Chordoma: Cohort 7
  8. description
    Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG007
    title
    ES 1600 mg: Cohort 8
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.31
          value
          37.9
        2. group Id
          BG001
          spread
          9.54
          value
          38.8
        3. group Id
          BG002
          spread
          16.94
          value
          46.9
        4. group Id
          BG003
          spread
          10.71
          value
          30.7
        5. group Id
          BG004
          spread
          15.08
          value
          37.0
        6. group Id
          BG005
          spread
          14.00
          value
          41.3
        7. group Id
          BG006
          spread
          17.49
          value
          38.9
        8. group Id
          BG007
          spread
          15.74
          value
          40.9
        9. group Id
          BG008
          spread
          14.89
          value
          39.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          23
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          113
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          39
        6. group Id
          BG005
          value
          43
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          154
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          21
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          53
        6. group Id
          BG005
          value
          55
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          231
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          22
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          26
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          47
        6. group Id
          BG005
          value
          54
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          200
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          17
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all participants who received at least 1 dose of tazemetostat.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      32
    2. group Id
      BG001
      value
      33
    3. group Id
      BG002
      value
      32
    4. group Id
      BG003
      value
      14
    5. group Id
      BG004
      value
      62
    6. group Id
      BG005
      value
      69
    7. group Id
      BG006
      value
      18
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      267
    units
    Participants
groups
  1. description
    Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG000
    title
    Rhabdoid Tumors: Cohort 1
  2. description
    Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG001
    title
    Synovial Sarcoma: Cohort 2
  3. description
    Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG002
    title
    Other INI1-negative: Cohort 3
  4. description
    Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG003
    title
    RMC: Cohort 4
  5. description
    Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG004
    title
    ES: Cohort 5
  6. description
    Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG005
    title
    ES Paired Biopsy: Cohort 6
  7. description
    Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG006
    title
    Chordoma: Cohort 7
  8. description
    Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    BG007
    title
    ES 1600 mg: Cohort 8
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.31
          value
          37.9
        2. group Id
          BG001
          spread
          9.54
          value
          38.8
        3. group Id
          BG002
          spread
          16.94
          value
          46.9
        4. group Id
          BG003
          spread
          10.71
          value
          30.7
        5. group Id
          BG004
          spread
          15.08
          value
          37.0
        6. group Id
          BG005
          spread
          14.00
          value
          41.3
        7. group Id
          BG006
          spread
          17.49
          value
          38.9
        8. group Id
          BG007
          spread
          15.74
          value
          40.9
        9. group Id
          BG008
          spread
          14.89
          value
          39.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          23
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          113
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          39
        6. group Id
          BG005
          value
          43
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          154
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          21
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          53
        6. group Id
          BG005
          value
          55
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          231
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          22
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          26
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          47
        6. group Id
          BG005
          value
          54
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          200
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          17
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all participants who received at least 1 dose of tazemetostat.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice