TriangleNCT02867592 · OUTCOME
Objective Response (Non-Osteosarcoma Strata)
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 the first 6 cycles of therapy
What was measured
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Response rates will be calculated as the percent of evaluable patients who are responders (Overall Best Response of Partial Response or Complete Response), and confidence intervals will be constructed accounting for the two-stage design.
Analysis population: All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol in non-osteosarcoma strata which were either statistical strata (Ewing's Sarcoma, Rhabdomyosarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, and Rare Tumors) or accrued enough patients to be analyzed (Wilms Tumor). Data is limited for Rare tumors due to low accrual.
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.
| Group | Source count |
|---|---|
| Ewing's Sarcoma | 13 |
| Rhabdomyosarcoma | 13 |
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 13 |
| Wilms Tumor | 13 |
| Rare Tumors | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ewing's Sarcoma | 0 | Not reported | 0.0 | 24.71 | Not reported |
| Rhabdomyosarcoma | 0 | Not reported | 0.0 | 24.71 | Not reported |
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma | 0 | Not reported | 0.0 | 24.71 | Not reported |
| Wilms Tumor | 0 | Not reported | 0.0 | 24.71 | Not reported |
| Rare Tumors | 13.04 | Not reported | 2.78 | 33.59 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 24.71
- value
- 0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 24.71
- value
- 0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 24.71
- value
- 0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 24.71
- value
- 0
- group Id
- OG004
- lower Limit
- 2.78
- upper Limit
- 33.59
- value
- 13.04
- 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
- units
- Participants
- description
- Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Response rates will be calculated as the percent of evaluable patients who are responders (Overall Best Response of Partial Response or Complete Response), and confidence intervals will be constructed accounting for the two-stage design.
- 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
- param Type
- NUMBER
- population Description
- All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol in non-osteosarcoma strata which were either statistical strata (Ewing's Sarcoma, Rhabdomyosarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, and Rare Tumors) or accrued enough patients to be analyzed (Wilms Tumor). Data is limited for Rare tumors due to low accrual.
- reporting Status
- POSTED
- time Frame
- Up to the first 6 cycles of therapy
- title
- Objective Response (Non-Osteosarcoma Strata)
- type
- PRIMARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice