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NCT02601950 · OUTCOME

All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48

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.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
At Weeks 12, 24, 32 and 48

What was measured

DCR was defined as the percentage of participants who achieved a confirmed response (CR or PR, as per RECIST v 1.1 criteria) or who have SD lasting at least 32 weeks from the start of treatment until disease progression or the start of subsequent anti-cancer therapy. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. SD was defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

Analysis population: ITT population included all participants who received at least 1 dose of tazemetostat.

Groups in this outcome

Rhabdoid Tumors: Cohort 1

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.

Synovial Sarcoma: Cohort 2

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.

Other INI1-negative: Cohort 3

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.

RMC: Cohort 4

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.

ES: Cohort 5

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.

ES Paired Biopsy: Cohort 6

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.

Chordoma: Cohort 7

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.

ES 1600 mg: Cohort 8

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Rhabdoid Tumors: Cohort 132
Synovial Sarcoma: Cohort 233
Other INI1-negative: Cohort 332
RMC: Cohort 414
ES: Cohort 562
ES Paired Biopsy: Cohort 669
Chordoma: Cohort 718
ES 1600 mg: Cohort 87

Reported measurements

Week 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rhabdoid Tumors: Cohort 121.9Not reported9.340.0Not reported
Synovial Sarcoma: Cohort 215.2Not reported5.131.9Not reported
Other INI1-negative: Cohort 340.6Not reported23.759.4Not reported
RMC: Cohort 421.4Not reported4.750.8Not reported
ES: Cohort 545.2Not reported32.558.3Not reported
ES Paired Biopsy: Cohort 636.2Not reported25.048.7Not reported
Chordoma: Cohort 750.0Not reported26.074.0Not reported
ES 1600 mg: Cohort 842.9Not reported9.981.6Not reported
Week 24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rhabdoid Tumors: Cohort 112.5Not reported3.529.0Not reported
Synovial Sarcoma: Cohort 29.1Not reported1.924.3Not reported
Other INI1-negative: Cohort 321.9Not reported9.340.0Not reported
RMC: Cohort 414.3Not reported1.842.8Not reported
ES: Cohort 529.0Not reported18.241.9Not reported
ES Paired Biopsy: Cohort 630.4Not reported19.942.7Not reported
Chordoma: Cohort 733.3Not reported13.359.0Not reported
ES 1600 mg: Cohort 842.9Not reported9.981.6Not reported
Week 32
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rhabdoid Tumors: Cohort 19.4Not reported2.025.0Not reported
Synovial Sarcoma: Cohort 23.0Not reported0.115.8Not reported
Other INI1-negative: Cohort 318.8Not reported7.236.4Not reported
RMC: Cohort 47.1Not reported0.233.9Not reported
ES: Cohort 525.8Not reported15.538.5Not reported
ES Paired Biopsy: Cohort 629.0Not reported18.741.2Not reported
Chordoma: Cohort 727.8Not reported9.753.5Not reported
ES 1600 mg: Cohort 814.3Not reported0.457.9Not reported
Week 48
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rhabdoid Tumors: Cohort 19.4Not reported2.025.0Not reported
Synovial Sarcoma: Cohort 23.0Not reported0.115.8Not reported
Other INI1-negative: Cohort 312.5Not reported3.529.0Not reported
RMC: Cohort 40.0Not reported0.023.2Not reported
ES: Cohort 524.2Not reported14.236.7Not reported
ES Paired Biopsy: Cohort 623.2Not reported13.934.9Not reported
Chordoma: Cohort 711.1Not reported1.434.7Not reported
ES 1600 mg: Cohort 814.3Not reported0.457.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.3
        upper Limit
        40.0
        value
        21.9
      2. group Id
        OG001
        lower Limit
        5.1
        upper Limit
        31.9
        value
        15.2
      3. group Id
        OG002
        lower Limit
        23.7
        upper Limit
        59.4
        value
        40.6
      4. group Id
        OG003
        lower Limit
        4.7
        upper Limit
        50.8
        value
        21.4
      5. group Id
        OG004
        lower Limit
        32.5
        upper Limit
        58.3
        value
        45.2
      6. group Id
        OG005
        lower Limit
        25.0
        upper Limit
        48.7
        value
        36.2
      7. group Id
        OG006
        lower Limit
        26.0
        upper Limit
        74.0
        value
        50.0
      8. group Id
        OG007
        lower Limit
        9.9
        upper Limit
        81.6
        value
        42.9
    title
    Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.5
        upper Limit
        29.0
        value
        12.5
      2. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        24.3
        value
        9.1
      3. group Id
        OG002
        lower Limit
        9.3
        upper Limit
        40.0
        value
        21.9
      4. group Id
        OG003
        lower Limit
        1.8
        upper Limit
        42.8
        value
        14.3
      5. group Id
        OG004
        lower Limit
        18.2
        upper Limit
        41.9
        value
        29.0
      6. group Id
        OG005
        lower Limit
        19.9
        upper Limit
        42.7
        value
        30.4
      7. group Id
        OG006
        lower Limit
        13.3
        upper Limit
        59.0
        value
        33.3
      8. group Id
        OG007
        lower Limit
        9.9
        upper Limit
        81.6
        value
        42.9
    title
    Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        25.0
        value
        9.4
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        15.8
        value
        3.0
      3. group Id
        OG002
        lower Limit
        7.2
        upper Limit
        36.4
        value
        18.8
      4. group Id
        OG003
        lower Limit
        0.2
        upper Limit
        33.9
        value
        7.1
      5. group Id
        OG004
        lower Limit
        15.5
        upper Limit
        38.5
        value
        25.8
      6. group Id
        OG005
        lower Limit
        18.7
        upper Limit
        41.2
        value
        29.0
      7. group Id
        OG006
        lower Limit
        9.7
        upper Limit
        53.5
        value
        27.8
      8. group Id
        OG007
        lower Limit
        0.4
        upper Limit
        57.9
        value
        14.3
    title
    Week 32
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        25.0
        value
        9.4
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        15.8
        value
        3.0
      3. group Id
        OG002
        lower Limit
        3.5
        upper Limit
        29.0
        value
        12.5
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        23.2
        value
        0.0
      5. group Id
        OG004
        lower Limit
        14.2
        upper Limit
        36.7
        value
        24.2
      6. group Id
        OG005
        lower Limit
        13.9
        upper Limit
        34.9
        value
        23.2
      7. group Id
        OG006
        lower Limit
        1.4
        upper Limit
        34.7
        value
        11.1
      8. group Id
        OG007
        lower Limit
        0.4
        upper Limit
        57.9
        value
        14.3
    title
    Week 48
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      33
    3. group Id
      OG002
      value
      32
    4. group Id
      OG003
      value
      14
    5. group Id
      OG004
      value
      62
    6. group Id
      OG005
      value
      69
    7. group Id
      OG006
      value
      18
    8. group Id
      OG007
      value
      7
    units
    Participants
description
DCR was defined as the percentage of participants who achieved a confirmed response (CR or PR, as per RECIST v 1.1 criteria) or who have SD lasting at least 32 weeks from the start of treatment until disease progression or the start of subsequent anti-cancer therapy. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. SD was defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    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
    OG004
    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
    OG005
    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
    OG006
    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
    OG007
    title
    ES 1600 mg: Cohort 8
param Type
NUMBER
population Description
ITT population included all participants who received at least 1 dose of tazemetostat.
reporting Status
POSTED
time Frame
At Weeks 12, 24, 32 and 48
title
All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice