NCT02180867 · OUTCOME
Feasible Dose: Adult
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- milligram
- Interval / dispersion
- Not reported
- Time frame
- After the first 6 weeks of Induction
What was measured
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
Analysis population: Adult patients, excluding 1 ineligible patient in Dose-Finding RT group
Groups in this outcome
All Adult Dose Finding CR Cohorts
Dose-Finding CR: Chemoradiation plus pazopanib
All Adult Dose Finding RT Cohorts
Dose-Finding RT: Radiation therapy plus pazopanib
| Group | Source count |
|---|---|
| All Adult Dose Finding CR Cohorts | 4 |
| All Adult Dose Finding RT Cohorts | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Adult Dose Finding CR Cohorts | 600 | Not reported | Not reported | Not reported | Not reported |
| All Adult Dose Finding RT Cohorts | 800 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 600
- group Id
- OG001
- value
- 800
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
- groups
- description
- Dose-Finding CR: Chemoradiation plus pazopanib
- id
- OG000
- title
- All Adult Dose Finding CR Cohorts
- description
- Dose-Finding RT: Radiation therapy plus pazopanib
- id
- OG001
- title
- All Adult Dose Finding RT Cohorts
- param Type
- NUMBER
- population Description
- Adult patients, excluding 1 ineligible patient in Dose-Finding RT group
- reporting Status
- POSTED
- time Frame
- After the first 6 weeks of Induction
- title
- Feasible Dose: Adult
- type
- PRIMARY
- unit Of Measure
- milligram
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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