TriangleNCT03245151 · OUTCOME
Phase 2: Objective Response Rate (ORR) at Week 16
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
- Week 16
What was measured
ORR at Week 16 was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at Week 16 based on investigator assessment according to response evaluation criteria in solid tumors (RECIST) version 1.1 for non-HGG cohorts and response assessment in neuro-oncology (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 less than (\<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (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 | 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
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- ORR at Week 16 was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at Week 16 based on investigator assessment according to response evaluation criteria in solid tumors (RECIST) version 1.1 for non-HGG cohorts and response assessment in neuro-oncology (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 less than (\<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (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
- Week 16
- title
- Phase 2: Objective Response Rate (ORR) at Week 16
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice