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NCT02601950 · FLOW

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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.

groups
  1. description
    Participants with rhabdoid tumors (malignant rhabdoid tumor \[MRT\], rhabdoid tumors of the kidney \[RTK\], atypical teratoid rhabdoid tumor \[ATRT\], and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type \[SCCOHT\], also known as malignant rhabdoid tumor of the ovary \[MRTO\]) received tazemetostat 800 milligram (mg) twice daily (BID) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    FG000
    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
    FG001
    title
    Synovial Sarcoma: Cohort 2
  3. description
    Participants with other integrase interactor 1 (INI-1)-negative tumors or any solid tumor with enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (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
    FG002
    title
    Other INI1-negative: Cohort 3
  4. description
    Participants with renal medullary carcinoma (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
    FG003
    title
    RMC: Cohort 4
  5. description
    Participants with epithelioid sarcoma (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
    FG004
    title
    ES: Cohort 5
  6. description
    Participants with ES undergoing optional tumor 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
    FG005
    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
    FG006
    title
    Chordoma: Cohort 7
  8. description
    Participants with ES received tazemetostat 1600 mg once daily (QD) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    FG007
    title
    ES 1600 mg: Cohort 8
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Participant enrolled in rollover study
    2. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        46
      6. group Id
        FG005
        num Subjects
        52
      7. group Id
        FG006
        num Subjects
        7
      8. group Id
        FG007
        num Subjects
        5
      type
      Disease progression - radiological
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        1
      type
      Disease progression - clinical
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Unacceptable toxicity (related to study treatment)
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Adverse event (not related to study treatment)
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Non-compliance
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        1
      type
      Participant refused further study treatment
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Investigator discretion
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        32
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        62
      6. group Id
        FG005
        num Subjects
        69
      7. group Id
        FG006
        num Subjects
        18
      8. group Id
        FG007
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        32
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        62
      6. group Id
        FG005
        num Subjects
        69
      7. group Id
        FG006
        num Subjects
        18
      8. group Id
        FG007
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were enrolled into 1 of the 8 cohorts based on tumor type. A total of 267 participants were enrolled in the study.
recruitment Details
This Phase II, open-label study was conducted at 28 sites in 9 countries (Australia, Belgium, Canada, France, Germany, Italy, Taiwan, United Kingdom, and United States) from 22 December 2015 to 26 February 2024.
Complete source fields
groups
  1. description
    Participants with rhabdoid tumors (malignant rhabdoid tumor \[MRT\], rhabdoid tumors of the kidney \[RTK\], atypical teratoid rhabdoid tumor \[ATRT\], and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type \[SCCOHT\], also known as malignant rhabdoid tumor of the ovary \[MRTO\]) received tazemetostat 800 milligram (mg) twice daily (BID) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    FG000
    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
    FG001
    title
    Synovial Sarcoma: Cohort 2
  3. description
    Participants with other integrase interactor 1 (INI-1)-negative tumors or any solid tumor with enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (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
    FG002
    title
    Other INI1-negative: Cohort 3
  4. description
    Participants with renal medullary carcinoma (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
    FG003
    title
    RMC: Cohort 4
  5. description
    Participants with epithelioid sarcoma (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
    FG004
    title
    ES: Cohort 5
  6. description
    Participants with ES undergoing optional tumor 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
    FG005
    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
    FG006
    title
    Chordoma: Cohort 7
  8. description
    Participants with ES received tazemetostat 1600 mg once daily (QD) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    FG007
    title
    ES 1600 mg: Cohort 8
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Participant enrolled in rollover study
    2. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        46
      6. group Id
        FG005
        num Subjects
        52
      7. group Id
        FG006
        num Subjects
        7
      8. group Id
        FG007
        num Subjects
        5
      type
      Disease progression - radiological
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        1
      type
      Disease progression - clinical
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Unacceptable toxicity (related to study treatment)
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Adverse event (not related to study treatment)
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Non-compliance
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        1
      type
      Participant refused further study treatment
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Investigator discretion
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        32
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        62
      6. group Id
        FG005
        num Subjects
        69
      7. group Id
        FG006
        num Subjects
        18
      8. group Id
        FG007
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        32
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        62
      6. group Id
        FG005
        num Subjects
        69
      7. group Id
        FG006
        num Subjects
        18
      8. group Id
        FG007
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were enrolled into 1 of the 8 cohorts based on tumor type. A total of 267 participants were enrolled in the study.
recruitment Details
This Phase II, open-label study was conducted at 28 sites in 9 countries (Australia, Belgium, Canada, France, Germany, Italy, Taiwan, United Kingdom, and United States) from 22 December 2015 to 26 February 2024.

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