TriangleNCT00602667 · OUTCOME
Topotecan AUC0-24h in Maintenance Chemotherapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- µg·h/L
- Interval / dispersion
- Full Range
- Time frame
- Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose
What was measured
Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
Analysis population: Eligible patients who received oral topotecan during maintenance therapy cycle A1 and had samples collected for PK analysis.
Groups in this outcome
Low-Risk Group
Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma
Intermediate-Risk Group
Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
High-Risk Group
Patients with central nervous system (CNS) metastatic disease
| Group | Source count |
|---|---|
| Low-Risk Group | 18 |
| Intermediate-Risk Group | 33 |
| High-Risk Group | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 10.90 | Not reported | 9.04 | 24.36 | Not reported |
| Intermediate-Risk Group | 11.60 | Not reported | 7.93 | 20.50 | Not reported |
| High-Risk Group | 10.33 | Not reported | 7.96 | 16.61 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.04
- upper Limit
- 24.36
- value
- 10.90
- group Id
- OG001
- lower Limit
- 7.93
- upper Limit
- 20.50
- value
- 11.60
- group Id
- OG002
- lower Limit
- 7.96
- upper Limit
- 16.61
- value
- 10.33
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
- dispersion Type
- Full Range
- groups
- description
- Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma
- id
- OG000
- title
- Low-Risk Group
- description
- Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
- id
- OG001
- title
- Intermediate-Risk Group
- description
- Patients with central nervous system (CNS) metastatic disease
- id
- OG002
- title
- High-Risk Group
- param Type
- MEDIAN
- population Description
- Eligible patients who received oral topotecan during maintenance therapy cycle A1 and had samples collected for PK analysis.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose
- title
- Topotecan AUC0-24h in Maintenance Chemotherapy
- type
- SECONDARY
- unit Of Measure
- µg·h/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice