TriangleNCT01136733 · OUTCOME
Maximum Concentration (Cmax) of Lenvatinib in Plasma When Administered Alone or in Combination With Everolimus
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Phase 2: Cycle 1 Day 15
What was measured
Cmax for lenvatinib was defined as the maximum observed concentration of lenvatinib in plasma following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured plasma concentration-time curves.
Analysis population: PK sub analysis set
Groups in this outcome
Phase 2: 18 mg Lenvatinib + 5 mg Everolimus
Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
Phase 2: 24 mg Lenvatinib
Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
| Group | Source count |
|---|---|
| Phase 2: 18 mg Lenvatinib + 5 mg Everolimus | 8 |
| Phase 2: 24 mg Lenvatinib | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: 18 mg Lenvatinib + 5 mg Everolimus | 327 | 179 | Not reported | Not reported | Not reported |
| Phase 2: 24 mg Lenvatinib | 403 | 165 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 179
- value
- 327
- group Id
- OG001
- spread
- 165
- value
- 403
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Cmax for lenvatinib was defined as the maximum observed concentration of lenvatinib in plasma following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured plasma concentration-time curves.
- dispersion Type
- Standard Deviation
- groups
- description
- Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
- id
- OG000
- title
- Phase 2: 18 mg Lenvatinib + 5 mg Everolimus
- description
- Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
- id
- OG001
- title
- Phase 2: 24 mg Lenvatinib
- param Type
- MEAN
- population Description
- PK sub analysis set
- reporting Status
- POSTED
- time Frame
- Phase 2: Cycle 1 Day 15
- title
- Maximum Concentration (Cmax) of Lenvatinib in Plasma When Administered Alone or in Combination With Everolimus
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice