TriangleNCT04447755 · OUTCOME
Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
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
- Up to approximately 21 months
What was measured
DOR was defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: 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, and demonstrated CR or PR.
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 | 2 |
| Rhabdomyosarcoma | 2 |
| High Grade Glioma | 0 |
| Diffuse Midline Glioma | 0 |
| Medulloblastoma | 0 |
| Ependymoma | 0 |
| Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ewing Sarcoma | NA | Not reported | 5.7 | NA | NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
| Rhabdomyosarcoma | 4.6 | Not reported | 3.7 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
| Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | 4.6 | Not reported | 3.7 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG000
- lower Limit
- 5.7
- upper Limit
- NA
- value
- NA
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- NA
- value
- 4.6
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG006
- lower Limit
- 3.7
- upper Limit
- NA
- value
- 4.6
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 5
- units
- Participants
- description
- DOR was defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: 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
- MEDIAN
- 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, and demonstrated CR or PR.
- reporting Status
- POSTED
- time Frame
- Up to approximately 21 months
- title
- Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice