TriangleNCT02601950 · OUTCOME
Cohorts 2 and 8: Objective Response Rate (ORR)
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
- 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
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.
Analysis population: ITT population included all participants who received at least 1 dose of tazemetostat.
Groups in this outcome
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.
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 |
|---|---|
| Synovial Sarcoma: Cohort 2 | 33 |
| ES 1600 mg: Cohort 8 | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Synovial Sarcoma: Cohort 2 | 0 | Not reported | 0.0 | 10.6 | Not reported |
| ES 1600 mg: Cohort 8 | 14.3 | Not reported | 0.4 | 57.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 10.6
- value
- 0
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 57.9
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- title
- Synovial Sarcoma: Cohort 2
- 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
- OG001
- 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
- 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
- Cohorts 2 and 8: Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice