TriangleNCT01445080 · OUTCOME
Area Under the Plasma Concentration Versus Time Curve (AUC) of Sorafenib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- µg•h/ml
- Interval / dispersion
- Full Range
- Time frame
- During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
What was measured
Area under the plasma concentration versus time curve (AUC) of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.
Analysis population: Pharmacokinetic (PK) studies were completed for stratums I and II. Summary statistics for PK analysis was performed regardless of dose level as pre-specified in the protocol. PK was not performed in stratum III
Groups in this outcome
STRATUM I (REFRACTORY SOLID TUMOR)
Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined, up to 6 additional patients under 12 years of age may be treated at the MTD. The MTD dose level is also expanded to enroll up to 6 patients with refractory leukemia.
STRATUM II (REFRACTORY LEUKEMIA)
A cohort of 3-6 patients with leukemia receives treatment as in stratum 1 at the MTD determined in stratum 1. If 2 of 3 or 2 of 6 patients experience a DLT at the solid tumor MTD, sorafenib is reduced by one dose level. The leukemia MTD is defined as the dose at which \< 1/3 of patients experience DLT during course 1 of treatment
| Group | Source count |
|---|---|
| STRATUM I (REFRACTORY SOLID TUMOR) | 29 |
| STRATUM II (REFRACTORY LEUKEMIA) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| STRATUM I (REFRACTORY SOLID TUMOR) | 38.66 | Not reported | 2.54 | 104.61 | Not reported |
| STRATUM II (REFRACTORY LEUKEMIA) | 50.03 | Not reported | 20.25 | 97.78 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.54
- upper Limit
- 104.61
- value
- 38.66
- group Id
- OG001
- lower Limit
- 20.25
- upper Limit
- 97.78
- value
- 50.03
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Area under the plasma concentration versus time curve (AUC) of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.
- dispersion Type
- Full Range
- groups
- description
- Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined, up to 6 additional patients under 12 years of age may be treated at the MTD. The MTD dose level is also expanded to enroll up to 6 patients with refractory leukemia.
- id
- OG000
- title
- STRATUM I (REFRACTORY SOLID TUMOR)
- description
- A cohort of 3-6 patients with leukemia receives treatment as in stratum 1 at the MTD determined in stratum 1. If 2 of 3 or 2 of 6 patients experience a DLT at the solid tumor MTD, sorafenib is reduced by one dose level. The leukemia MTD is defined as the dose at which \< 1/3 of patients experience DLT during course 1 of treatment
- id
- OG001
- title
- STRATUM II (REFRACTORY LEUKEMIA)
- param Type
- MEAN
- population Description
- Pharmacokinetic (PK) studies were completed for stratums I and II. Summary statistics for PK analysis was performed regardless of dose level as pre-specified in the protocol. PK was not performed in stratum III
- reporting Status
- POSTED
- time Frame
- During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
- title
- Area Under the Plasma Concentration Versus Time Curve (AUC) of Sorafenib
- type
- PRIMARY
- unit Of Measure
- µg•h/ml
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Preserved source evidence · Not medical advice