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NCT02601950 · OUTCOME

All Cohorts: Progression-Free Survival (PFS)

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
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)

What was measured

PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.

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

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rhabdoid Tumors: Cohort 17.9Not reported7.715.1Not reported
Synovial Sarcoma: Cohort 28.0Not reported7.68.1Not reported
Other INI1-negative: Cohort 315.7Not reported7.731.7Not reported
RMC: Cohort 47.3Not reported6.315.1Not reported
ES: Cohort 523.7Not reported14.725.7Not reported
ES Paired Biopsy: Cohort 616.1Not reported8.416.6Not reported
Chordoma: Cohort 724.0Not reported6.3175.3Not reported
ES 1600 mg: Cohort 839.9Not reported4.1NANA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events at study closure.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.7
        upper Limit
        15.1
        value
        7.9
      2. group Id
        OG001
        lower Limit
        7.6
        upper Limit
        8.1
        value
        8.0
      3. group Id
        OG002
        lower Limit
        7.7
        upper Limit
        31.7
        value
        15.7
      4. group Id
        OG003
        lower Limit
        6.3
        upper Limit
        15.1
        value
        7.3
      5. group Id
        OG004
        lower Limit
        14.7
        upper Limit
        25.7
        value
        23.7
      6. group Id
        OG005
        lower Limit
        8.4
        upper Limit
        16.6
        value
        16.1
      7. group Id
        OG006
        lower Limit
        6.3
        upper Limit
        175.3
        value
        24.0
      8. comment
        NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events at study closure.
        group Id
        OG007
        lower Limit
        4.1
        upper Limit
        NA
        value
        39.9
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
PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.
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
MEDIAN
population Description
ITT population included all participants who received at least 1 dose of tazemetostat.
reporting Status
POSTED
time Frame
Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)
title
All Cohorts: Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
Weeks

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Preserved source evidence · Not medical advice