TriangleNCT02601950 · OUTCOME
All Cohorts: Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- Full Range
- 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
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.
Analysis population: 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.
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 | 3 |
| Synovial Sarcoma: Cohort 2 | 0 |
| Other INI1-negative: Cohort 3 | 3 |
| RMC: Cohort 4 | 0 |
| ES: Cohort 5 | 10 |
| ES Paired Biopsy: Cohort 6 | 11 |
| Chordoma: Cohort 7 | 1 |
| ES 1600 mg: Cohort 8 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rhabdoid Tumors: Cohort 1 | 29.0 | Not reported | 24.1 | 32.1 | Not reported |
| Other INI1-negative: Cohort 3 | 80.1 | Not reported | 24.1 | 87.6 | Not reported |
| ES: Cohort 5 | 88.0 | Not reported | 7.1 | 224.4 | Not reported |
| ES Paired Biopsy: Cohort 6 | 96.1 | Not reported | 10.3 | 112.3 | Not reported |
| Chordoma: Cohort 7 | 151.6 | Not reported | 151.6 | 151.6 | Not reported |
| ES 1600 mg: Cohort 8 | 119.4 | Not reported | 119.4 | 119.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.1
- upper Limit
- 32.1
- value
- 29.0
- group Id
- OG002
- lower Limit
- 24.1
- upper Limit
- 87.6
- value
- 80.1
- group Id
- OG004
- lower Limit
- 7.1
- upper Limit
- 224.4
- value
- 88.0
- group Id
- OG005
- lower Limit
- 10.3
- upper Limit
- 112.3
- value
- 96.1
- group Id
- OG006
- lower Limit
- 151.6
- upper Limit
- 151.6
- value
- 151.6
- group Id
- OG007
- lower Limit
- 119.4
- upper Limit
- 119.4
- value
- 119.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- units
- Participants
- description
- 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.
- dispersion Type
- Full Range
- 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. Only those participants with a confirmed CR or PR (responders) were analyzed.
- 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: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Weeks
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Preserved source evidence · Not medical advice