Trial · NCT02601950
A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma
NCT02601950, Phase 2, Completed, Epizyme, Inc.; results first posted 2025-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma. Trials, record NCT02601950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02601950
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma
- NCT number
- NCT02601950
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 267 participants, actual
- Lead sponsor
- Epizyme, Inc.
- Conditions
Malignant Rhabdoid Tumors (MRT), Rhabdoid Tumors of the Kidney (RTK), Atypical Teratoid Rhabdoid Tumors (ATRT), Selected Tumors With Rhabdoid Features, Synovial Sarcoma, INI1-negative Tumors, Malignant Rhabdoid Tumor of Ovary, Renal Medullary Carcinoma, Epithelioid Sarcoma, Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval), Any Solid Tumor With an EZH2 GOF Mutation
- Interventions
- Tazemetostat
- First posted
- 2015-11-11
- Last updated
- 2025-06-22
- Other registries' IDs
- eudract:2015-002469-41
- Results first posted
- 2025-03-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR) | 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) | ORR was defined as percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) based on the investigator review from start of treatment until progressive disease (PD) or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per response assessment in neuro-oncology (RANO) criteria for primary brain tumors or response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in 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. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase from nadir of 5 mm. |
| Primary | Cohort 2: Progression-Free Survival (PFS) Rate at 16 Weeks of Treatment With Tazemetostat | At 16 Weeks | 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. PFS rate at 16 week was estimated. 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. |
| Primary | Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 148 weeks | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was medically significant. TEAEs were defined as AEs if one of the following conditions met: emerged after the time of first dose administration, having been absent prior to the first dose; re-emerged, having been present but stopped prior to the time of first dose administration; worsened in severity after the time of first dose administration relative to the pretreatment state, when the AE was continuous. |
| Secondary | All Cohorts: Duration of Response (DOR) | 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) | DOR was defined as time from the first documented evidence of CR or PR based on investigator review to the time of first documented PD or death due to any cause, whichever came first, as per RECIST v 1.1 criteria. 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. 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. |
| Secondary | All Cohorts: Progression-Free Survival (PFS) | 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) | 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. |
| Secondary | All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56 | At Weeks 24, 32 and 56 | 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. PFS rate at 24, 32 and 56 weeks were estimated. 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. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation. |
| Secondary | All Cohorts: Overall Survival (OS) | 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) | OS was defined as the interval of time between the date of the first dose of study treatment and the date of death due to any cause. |
| Secondary | All Cohorts: Overall Survival (OS) Rate at Weeks 24, 32 and 56 | At Weeks 24, 32 and 56 | OS was defined as the interval of time between the date of the first dose of study treatment and the date of death due to any cause. OS rate at 24, 32 and 56 weeks were estimated. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation. |
| Secondary | All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48 | At Weeks 12, 24, 32 and 48 | 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. |
| Secondary | Cohorts 2 and 8: Objective Response Rate (ORR) | 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) | ORR was defined as percentage of participants who achieved a confirmed CR or PR based on investigator assessment from start of treatment until PD or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per RANO criteria for primary brain tumors or RECIST v 1.1 criteria for all other solid tumors. 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. 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR) | 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) | ITT population included all participants who received at least 1 dose of tazemetostat. | Percentage of participants | NUMBER |
| PRIMARY | Cohort 2: Progression-Free Survival (PFS) Rate at 16 Weeks of Treatment With Tazemetostat | At 16 Weeks | ITT population included all participants who received at least 1 dose of tazemetostat. | Percentage of participants | NUMBER |
| PRIMARY | Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 148 weeks | Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cohorts: Duration of Response (DOR) | 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) | ITT population included all participants who received at least 1 dose of tazemetostat. Only those participants with a confirmed CR or PR (responders) were analyzed. | Weeks | MEDIAN |
| SECONDARY | All Cohorts: Progression-Free Survival (PFS) | 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) | ITT population included all participants who received at least 1 dose of tazemetostat. | Weeks | MEDIAN |
| SECONDARY | All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56 | At Weeks 24, 32 and 56 | ITT population included all participants who received at least 1 dose of tazemetostat. | Percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Overall Survival (OS) | 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) | ITT population included all participants who received at least 1 dose of tazemetostat. | Weeks | MEDIAN |
| SECONDARY | All Cohorts: Overall Survival (OS) Rate at Weeks 24, 32 and 56 | At Weeks 24, 32 and 56 | ITT population included all participants who received at least 1 dose of tazemetostat. | Percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48 | At Weeks 12, 24, 32 and 48 | ITT population included all participants who received at least 1 dose of tazemetostat. | Percentage of participants | NUMBER |
| SECONDARY | Cohorts 2 and 8: Objective Response Rate (ORR) | 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) | ITT population included all participants who received at least 1 dose of tazemetostat. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group113
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR) | Rhabdoid Tumors: Cohort 1 | 9.4 | 95% Confidence Interval 2.0 to 25.0 | Percentage of participants | |
| Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR) | Other INI1-negative: Cohort 3 | 9.4 | 95% Confidence Interval 2.0 to 25.0 | Percentage of participants | |
| Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR) | RMC: Cohort 4 | 0.0 | 95% Confidence Interval 0.0 to 23.2 | Percentage of participants | |
| Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR) | ES: Cohort 5 | 16.1 | 95% Confidence Interval 8.0 to 27.7 | Percentage of participants | |
| Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR) | ES Paired Biopsy: Cohort 6 | 15.9 | 95% Confidence Interval 8.2 to 26.7 | Percentage of participants | |
| Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR) | Chordoma: Cohort 7 | 5.6 | 95% Confidence Interval 0.1 to 27.3 | Percentage of participants | |
| Cohort 2: Progression-Free Survival (PFS) Rate at 16 Weeks of Treatment With Tazemetostat | Synovial Sarcoma: Cohort 2 | 15.2 | 95% Confidence Interval 5.1 to 31.9 | Percentage of participants | |
| Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | ES 1600 mg: Cohort 8 | TEAEs | 7 | Participants | |
| Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | ES 1600 mg: Cohort 8 | TESAEs | 2 | Participants | |
| All Cohorts: Duration of Response (DOR) | Rhabdoid Tumors: Cohort 1 | 29.0 | Full Range 24.1 to 32.1 | Weeks |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rhabdoid Tumors: Cohort 1 | 32 | |
| Overall Study | STARTED | Synovial Sarcoma: Cohort 2 | 33 | |
| Overall Study | STARTED | Other INI1-negative: Cohort 3 | 32 | |
| Overall Study | STARTED | RMC: Cohort 4 | 14 | |
| Overall Study | STARTED | ES: Cohort 5 | 62 | |
| Overall Study | STARTED | ES Paired Biopsy: Cohort 6 | 69 | |
| Overall Study | STARTED | Chordoma: Cohort 7 | 18 | |
| Overall Study | STARTED | ES 1600 mg: Cohort 8 | 7 | |
| Overall Study | COMPLETED | Rhabdoid Tumors: Cohort 1 | 0 | |
| Overall Study | COMPLETED | Synovial Sarcoma: Cohort 2 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events992
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Rhabdoid Tumors: Cohort 1 | 10 | 32 | 15 |
| other | Nausea | Gastrointestinal disorders | Synovial Sarcoma: Cohort 2 | 9 | 33 | 14 |
| other | Nausea | Gastrointestinal disorders | Other INI1-Negative: Cohort 3 | 9 | 32 | 18 |
| other | Nausea | Gastrointestinal disorders | RMC: Cohort 4 | 3 | 14 | 3 |
| other | Nausea | Gastrointestinal disorders | ES: Cohort 5 | 23 | 62 | 31 |
| other | Nausea | Gastrointestinal disorders | ES Paired Biopsy: Cohort 6 | 32 | 69 | 43 |
| other | Nausea | Gastrointestinal disorders | Chordoma: Cohort 7 | 8 | 18 | 10 |
| other | Nausea | Gastrointestinal disorders | ES 1600 mg: Cohort 8 | 3 | 7 | 5 |
| other | Vomiting | Gastrointestinal disorders | Rhabdoid Tumors: Cohort 1 | 13 | 32 | 18 |
| other | Vomiting | Gastrointestinal disorders | Synovial Sarcoma: Cohort 2 | 1 | 33 | 2 |
1 to 10 of 992Source ClinicalTrials.gov
See all 992 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rhabdoid Tumors: Cohort 1 | 9 | 32 |
| Total, all-cause mortality | Synovial Sarcoma: Cohort 2 | 2 | 33 |
| Total, all-cause mortality | Other INI1-Negative: Cohort 3 | 5 | 32 |
| Total, all-cause mortality | RMC: Cohort 4 | 3 | 14 |
| Total, all-cause mortality | ES: Cohort 5 | 8 | 62 |
| Total, all-cause mortality | ES Paired Biopsy: Cohort 6 | 6 | 69 |
| Total, all-cause mortality | Chordoma: Cohort 7 | 2 | 18 |
| Total, all-cause mortality | ES 1600 mg: Cohort 8 | 0 | 7 |
| Total, other adverse events | Rhabdoid Tumors: Cohort 1 | 27 | 32 |
| Total, other adverse events | Synovial Sarcoma: Cohort 2 | 28 | 33 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33035459 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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