TriangleNCT02601950 · OUTCOME
All Cohorts: Overall Survival (OS)
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
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.
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 | Source count |
|---|---|
| Rhabdoid Tumors: Cohort 1 | 32 |
| Synovial Sarcoma: Cohort 2 | 33 |
| Other INI1-negative: Cohort 3 | 32 |
| RMC: Cohort 4 | 14 |
| ES: Cohort 5 | 62 |
| ES Paired Biopsy: Cohort 6 | 69 |
| Chordoma: Cohort 7 | 18 |
| ES 1600 mg: Cohort 8 | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rhabdoid Tumors: Cohort 1 | 22.1 | Not reported | 14.4 | 54.6 | Not reported |
| Synovial Sarcoma: Cohort 2 | 43.4 | Not reported | 31.7 | 58.1 | Not reported |
| Other INI1-negative: Cohort 3 | 37.9 | Not reported | 23.3 | 104.0 | Not reported |
| RMC: Cohort 4 | 24.6 | Not reported | 8.4 | 73.6 | Not reported |
| ES: Cohort 5 | 82.4 | Not reported | 47.4 | 117.0 | Not reported |
| ES Paired Biopsy: Cohort 6 | 111.4 | Not reported | 63.0 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure. |
| Chordoma: Cohort 7 | 77.7 | Not reported | 32.9 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure. |
| ES 1600 mg: Cohort 8 | 49.6 | Not reported | 19.3 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.4
- upper Limit
- 54.6
- value
- 22.1
- group Id
- OG001
- lower Limit
- 31.7
- upper Limit
- 58.1
- value
- 43.4
- group Id
- OG002
- lower Limit
- 23.3
- upper Limit
- 104.0
- value
- 37.9
- group Id
- OG003
- lower Limit
- 8.4
- upper Limit
- 73.6
- value
- 24.6
- group Id
- OG004
- lower Limit
- 47.4
- upper Limit
- 117.0
- value
- 82.4
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
- group Id
- OG005
- lower Limit
- 63.0
- upper Limit
- NA
- value
- 111.4
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
- group Id
- OG006
- lower Limit
- 32.9
- upper Limit
- NA
- value
- 77.7
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
- group Id
- OG007
- lower Limit
- 19.3
- upper Limit
- NA
- value
- 49.6
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 32
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 62
- group Id
- OG005
- value
- 69
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 7
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Weeks
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Preserved source evidence · Not medical advice