NCT02867592 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 1 year
What was measured
The 1-year Progression Free Survival will be estimated using Kaplan-Meier methodology. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as a \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Analysis population: All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol.
Groups in this outcome
Ewing's Sarcoma
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Rhabdomyosarcoma
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Non-Rhabdomyosarcoma Soft Tissue Sarcoma
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Wilms Tumor
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Rare Tumors
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Osteosarcoma
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Ewing's Sarcoma | 13 |
| Rhabdomyosarcoma | 13 |
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 13 |
| Wilms Tumor | 13 |
| Rare Tumors | 23 |
| Osteosarcoma | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ewing's Sarcoma | 15.39 | Not reported | 2.48 | 38.78 | Not reported |
| Rhabdomyosarcoma | 0 | Not reported | 0 | 0 | Not reported |
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 15.39 | Not reported | 2.48 | 38.78 | Not reported |
| Wilms Tumor | 23.08 | Not reported | 5.58 | 47.46 | Not reported |
| Rare Tumors | 13.04 | Not reported | 3.27 | 29.72 | Not reported |
| Osteosarcoma | 14.71 | Not reported | 4.66 | 30.19 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.48
- upper Limit
- 38.78
- value
- 15.39
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG002
- lower Limit
- 2.48
- upper Limit
- 38.78
- value
- 15.39
- group Id
- OG003
- lower Limit
- 5.58
- upper Limit
- 47.46
- value
- 23.08
- group Id
- OG004
- lower Limit
- 3.27
- upper Limit
- 29.72
- value
- 13.04
- group Id
- OG005
- lower Limit
- 4.66
- upper Limit
- 30.19
- value
- 14.71
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 23
- group Id
- OG005
- value
- 29
- units
- Participants
- description
- The 1-year Progression Free Survival will be estimated using Kaplan-Meier methodology. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as a \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Ewing's Sarcoma
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Rhabdomyosarcoma
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Non-Rhabdomyosarcoma Soft Tissue Sarcoma
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Wilms Tumor
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Rare Tumors
- description
- Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG005
- title
- Osteosarcoma
- param Type
- NUMBER
- population Description
- All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol.
- reporting Status
- POSTED
- time Frame
- Up to 1 year
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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