TriangleNCT02601950 · OUTCOME
All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56
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 24, 32 and 56
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. 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.
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
Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rhabdoid Tumors: Cohort 1 | 17.6 | Not reported | 6.5 | 33.1 | Not reported |
| Synovial Sarcoma: Cohort 2 | 15.9 | Not reported | 5.1 | 32.0 | Not reported |
| Other INI1-negative: Cohort 3 | 34.4 | Not reported | 18.2 | 51.2 | Not reported |
| RMC: Cohort 4 | 15.4 | Not reported | 2.5 | 38.8 | Not reported |
| ES: Cohort 5 | 42.1 | Not reported | 29.3 | 54.4 | Not reported |
| ES Paired Biopsy: Cohort 6 | 33.8 | Not reported | 22.9 | 45.0 | Not reported |
| Chordoma: Cohort 7 | 43.6 | Not reported | 18.2 | 66.7 | Not reported |
| ES 1600 mg: Cohort 8 | 53.6 | Not reported | 13.2 | 82.5 | Not reported |
Week 32
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rhabdoid Tumors: Cohort 1 | 14.1 | Not reported | 4.5 | 28.9 | Not reported |
| Synovial Sarcoma: Cohort 2 | 10.6 | Not reported | 2.2 | 26.7 | Not reported |
| Other INI1-negative: Cohort 3 | 26.7 | Not reported | 12.3 | 43.5 | Not reported |
| RMC: Cohort 4 | 15.4 | Not reported | 2.5 | 38.8 | Not reported |
| ES: Cohort 5 | 29.1 | Not reported | 17.9 | 41.2 | Not reported |
| ES Paired Biopsy: Cohort 6 | 29.3 | Not reported | 19.1 | 40.4 | Not reported |
| Chordoma: Cohort 7 | 43.6 | Not reported | 18.2 | 66.7 | Not reported |
| ES 1600 mg: Cohort 8 | 53.6 | Not reported | 13.2 | 82.5 | Not reported |
Week 56
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rhabdoid Tumors: Cohort 1 | 3.5 | Not reported | 0.3 | 15.2 | Not reported |
| Synovial Sarcoma: Cohort 2 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Other INI1-negative: Cohort 3 | 13.8 | Not reported | 3.8 | 29.9 | Not reported |
| RMC: Cohort 4 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| ES: Cohort 5 | 21.3 | Not reported | 11.6 | 33.0 | Not reported |
| ES Paired Biopsy: Cohort 6 | 22.6 | Not reported | 13.3 | 33.3 | Not reported |
| Chordoma: Cohort 7 | 18.2 | Not reported | 1.5 | 50.3 | Not reported |
| ES 1600 mg: Cohort 8 | 26.8 | Not reported | 1.3 | 67.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.5
- upper Limit
- 33.1
- value
- 17.6
- group Id
- OG001
- lower Limit
- 5.1
- upper Limit
- 32.0
- value
- 15.9
- group Id
- OG002
- lower Limit
- 18.2
- upper Limit
- 51.2
- value
- 34.4
- group Id
- OG003
- lower Limit
- 2.5
- upper Limit
- 38.8
- value
- 15.4
- group Id
- OG004
- lower Limit
- 29.3
- upper Limit
- 54.4
- value
- 42.1
- group Id
- OG005
- lower Limit
- 22.9
- upper Limit
- 45.0
- value
- 33.8
- group Id
- OG006
- lower Limit
- 18.2
- upper Limit
- 66.7
- value
- 43.6
- group Id
- OG007
- lower Limit
- 13.2
- upper Limit
- 82.5
- value
- 53.6
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 28.9
- value
- 14.1
- group Id
- OG001
- lower Limit
- 2.2
- upper Limit
- 26.7
- value
- 10.6
- group Id
- OG002
- lower Limit
- 12.3
- upper Limit
- 43.5
- value
- 26.7
- group Id
- OG003
- lower Limit
- 2.5
- upper Limit
- 38.8
- value
- 15.4
- group Id
- OG004
- lower Limit
- 17.9
- upper Limit
- 41.2
- value
- 29.1
- group Id
- OG005
- lower Limit
- 19.1
- upper Limit
- 40.4
- value
- 29.3
- group Id
- OG006
- lower Limit
- 18.2
- upper Limit
- 66.7
- value
- 43.6
- group Id
- OG007
- lower Limit
- 13.2
- upper Limit
- 82.5
- value
- 53.6
- title
- Week 32
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.3
- upper Limit
- 15.2
- value
- 3.5
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 3.8
- upper Limit
- 29.9
- value
- 13.8
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG004
- lower Limit
- 11.6
- upper Limit
- 33.0
- value
- 21.3
- group Id
- OG005
- lower Limit
- 13.3
- upper Limit
- 33.3
- value
- 22.6
- group Id
- OG006
- lower Limit
- 1.5
- upper Limit
- 50.3
- value
- 18.2
- group Id
- OG007
- lower Limit
- 1.3
- upper Limit
- 67.0
- value
- 26.8
- title
- Week 56
- 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
- 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.
- 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
- NUMBER
- population Description
- ITT population included all participants who received at least 1 dose of tazemetostat.
- reporting Status
- POSTED
- time Frame
- At Weeks 24, 32 and 56
- title
- All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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