TriangleNCT01897571 · OUTCOME
Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during Cycles 2 to 6, and then every 12 weeks thereafter until confirmed PD/death, a maximum of approximately 82 months
What was measured
The time (in months) from the date of the initial response (CR or PR, whichever was first) until the date of the first documented disease progression per an Independent Review Committee (for Groups 1 and 2), per Investigator (Group 3), or death due to any cause. Patients who were alive and progression free at the time of the analysis were censored at the last date where the patient was known to be in response. Note: the DOR was censored, meaning data collection was stopped early for analysis, making the top limit of the 95% confidence interval not estimable (NE). Per RECIST v.1.0, CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Analysis population: Patients who had a complete or partial response per an Independent Review Committee. Note: the DOR for some patients was censored, meaning data collection was stopped early for analysis making the top limit of the 95% confidence interval not estimable.
Groups in this outcome
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2
Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
Phase 2 Group 4: Tazemetostat + Prednisone in R/R DLBCL Combination Therapy
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
| Group | Source count |
|---|---|
| Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2 | 34 |
| Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2 | 19 |
| Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy | 163 |
| Phase 2 Group 4: Tazemetostat + Prednisone in R/R DLBCL Combination Therapy | 71 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2 | 11.3 | Not reported | 7.2 | NA | NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events at study closure. |
| Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2 | 13.0 | Not reported | 5.6 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure. |
| Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy | 5.8 | Not reported | 3.7 | 12.8 | Not reported |
| Phase 2 Group 4: Tazemetostat + Prednisone in R/R DLBCL Combination Therapy | 5.7 | Not reported | 2.1 | 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
- comment
- NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events at study closure.
- group Id
- OG000
- lower Limit
- 7.2
- upper Limit
- NA
- value
- 11.3
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 13.0
- group Id
- OG002
- lower Limit
- 3.7
- upper Limit
- 12.8
- value
- 5.8
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
- group Id
- OG003
- lower Limit
- 2.1
- upper Limit
- NA
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 163
- group Id
- OG003
- value
- 71
- units
- Participants
- description
- The time (in months) from the date of the initial response (CR or PR, whichever was first) until the date of the first documented disease progression per an Independent Review Committee (for Groups 1 and 2), per Investigator (Group 3), or death due to any cause. Patients who were alive and progression free at the time of the analysis were censored at the last date where the patient was known to be in response. Note: the DOR was censored, meaning data collection was stopped early for analysis, making the top limit of the 95% confidence interval not estimable (NE). Per RECIST v.1.0, CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2
- description
- Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
- description
- Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
- id
- OG002
- title
- Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
- description
- Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
- id
- OG003
- title
- Phase 2 Group 4: Tazemetostat + Prednisone in R/R DLBCL Combination Therapy
- param Type
- MEDIAN
- population Description
- Patients who had a complete or partial response per an Independent Review Committee. Note: the DOR for some patients was censored, meaning data collection was stopped early for analysis making the top limit of the 95% confidence interval not estimable.
- reporting Status
- POSTED
- time Frame
- Radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during Cycles 2 to 6, and then every 12 weeks thereafter until confirmed PD/death, a maximum of approximately 82 months
- title
- Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice