TriangleNCT01897571 · OUTCOME
Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- 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 disease progression (PD)/death,a maximum of approximately 82 months
What was measured
Number of patients achieving an objective response (CR or PR)/number of patients treated x 100%. ORR was calculated as the percentage of patients with a confirmed complete response (CR) or partial response (PR) relative to the total number of patients in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (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.
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 + Prednisolone 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 | 48 |
| Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2 | 54 |
| Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy | 163 |
| Phase 2 Group 4: Tazemetostat + Prednisolone 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 | 34 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2 | 19 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy | 30 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 30
- group Id
- OG003
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 163
- group Id
- OG003
- value
- 71
- units
- Participants
- description
- Number of patients achieving an objective response (CR or PR)/number of patients treated x 100%. ORR was calculated as the percentage of patients with a confirmed complete response (CR) or partial response (PR) relative to the total number of patients in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (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.
- 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 + Prednisolone in R/R DLBCL Combination Therapy
- param Type
- COUNT_OF_PARTICIPANTS
- 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 disease progression (PD)/death,a maximum of approximately 82 months
- title
- Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice