TriangleNCT03245151 · OUTCOME
Phase 2: 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
- From the date of the first dose of study drug to the date of first documentation of disease progression or death, which ever occurred first (up to 6.5 months)
What was measured
ORR was defined as the percentage of participants with BOR of CR or PR based on investigator assessment according to RECIST version 1.1 for non-HGG cohorts and RANO for HGG cohort. CR was defined as disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters.
Analysis population: Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease.
Groups in this outcome
Phase 2: Cohort 1, Ewing Sarcoma
Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Cohort 2, Rhabdomyosarcoma
Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Cohort 3, HGG
Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
| Group | Source count |
|---|---|
| Phase 2: Cohort 1, Ewing Sarcoma | 10 |
| Phase 2: Cohort 2, Rhabdomyosarcoma | 20 |
| Phase 2: Cohort 3, HGG | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1, Ewing Sarcoma | 0.0 | 0.0 | 0.0 | 30.8 | Not reported |
| Phase 2: Cohort 2, Rhabdomyosarcoma | 10.0 | 1.2 | 1.2 | 31.7 | Not reported |
| Phase 2: Cohort 3, HGG | 0.0 | 0.0 | 0.0 | 30.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- spread
- 0.0
- upper Limit
- 30.8
- value
- 0.0
- group Id
- OG001
- lower Limit
- 1.2
- spread
- 1.2
- upper Limit
- 31.7
- value
- 10.0
- group Id
- OG002
- lower Limit
- 0.0
- spread
- 0.0
- upper Limit
- 30.8
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- ORR was defined as the percentage of participants with BOR of CR or PR based on investigator assessment according to RECIST version 1.1 for non-HGG cohorts and RANO for HGG cohort. CR was defined as disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
- id
- OG000
- title
- Phase 2: Cohort 1, Ewing Sarcoma
- description
- Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
- id
- OG001
- title
- Phase 2: Cohort 2, Rhabdomyosarcoma
- description
- Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
- id
- OG002
- title
- Phase 2: Cohort 3, HGG
- param Type
- NUMBER
- population Description
- Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease.
- reporting Status
- POSTED
- time Frame
- From the date of the first dose of study drug to the date of first documentation of disease progression or death, which ever occurred first (up to 6.5 months)
- title
- Phase 2: 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