TriangleNCT04447755 · OUTCOME
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment
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
- Up to 16 weeks
What was measured
ORR at Week 16 was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response was assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
Analysis population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
Groups in this outcome
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
High Grade Glioma
Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Diffuse Midline Glioma
Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Medulloblastoma
Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Ependymoma
Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
| Group | Source count |
|---|---|
| Ewing Sarcoma | 9 |
| Rhabdomyosarcoma | 17 |
| High Grade Glioma | 6 |
| Diffuse Midline Glioma | 9 |
| Medulloblastoma | 9 |
| Ependymoma | 9 |
| Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | 65 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ewing Sarcoma | 22.2 | Not reported | 2.8 | 60.0 | Not reported |
| Rhabdomyosarcoma | 11.8 | Not reported | 1.5 | 36.4 | Not reported |
| High Grade Glioma | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Diffuse Midline Glioma | 0.0 | Not reported | 0.0 | 33.6 | Not reported |
| Medulloblastoma | 0.0 | Not reported | 0.0 | 33.6 | Not reported |
| Ependymoma | 0.0 | Not reported | 0.0 | 33.6 | Not reported |
| Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | 7.7 | Not reported | 2.5 | 17.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 60.0
- value
- 22.2
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 36.4
- value
- 11.8
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 33.6
- value
- 0.0
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 33.6
- value
- 0.0
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 33.6
- value
- 0.0
- group Id
- OG006
- lower Limit
- 2.5
- upper Limit
- 17.0
- value
- 7.7
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 65
- units
- Participants
- description
- ORR at Week 16 was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response was assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- Ewing Sarcoma
- description
- Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
- id
- OG001
- title
- Rhabdomyosarcoma
- description
- Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
- id
- OG002
- title
- High Grade Glioma
- description
- Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
- id
- OG003
- title
- Diffuse Midline Glioma
- description
- Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
- id
- OG004
- title
- Medulloblastoma
- description
- Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
- id
- OG005
- title
- Ependymoma
- description
- Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
- id
- OG006
- title
- Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
- param Type
- NUMBER
- population Description
- All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
- reporting Status
- POSTED
- time Frame
- Up to 16 weeks
- title
- Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice