TriangleNCT01136733 · OUTCOME
Summary of Blood Concentrations of Everolimus for Sparse PK Sampling for Phase 1b and Phase 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)
What was measured
Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Whole blood concentrations of everolimus were measured and concentration data were summarized. The summary statistics at time points with one or more BLQ values were calculated by assigning zero for each BLQ value.
Analysis population: Pharmacokinetic analysis set included all participants who received at least one dose of study drug (lenvatinib or everolimus) and had evaluable concentration data.
Groups in this outcome
Cycle 1, Day 1 (0 Hours)
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
Cycle 1, Day 1 (2-8 Hours)
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
Cycle 2, Day 1 (0 Hours)
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
Cycle 2, Day 1 (2-8 Hours)
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
Cycle 3, Day 1 (0 Hours)
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
Cycle 3, Day 1 (2-8 Hours)
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
| Group | Source count |
|---|---|
| Cycle 1, Day 1 (0 Hours) | 37 |
| Cycle 1, Day 1 (2-8 Hours) | 35 |
| Cycle 2, Day 1 (0 Hours) | 29 |
| Cycle 2, Day 1 (2-8 Hours) | 28 |
| Cycle 3, Day 1 (0 Hours) | 27 |
| Cycle 3, Day 1 (2-8 Hours) | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cycle 1, Day 1 (0 Hours) | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Cycle 1, Day 1 (2-8 Hours) | 19.4 | 9.16 | Not reported | Not reported | Not reported |
| Cycle 2, Day 1 (0 Hours) | 10.0 | 7.28 | Not reported | Not reported | Not reported |
| Cycle 2, Day 1 (2-8 Hours) | 24.3 | 14.2 | Not reported | Not reported | Not reported |
| Cycle 3, Day 1 (0 Hours) | 6.8 | 6.06 | Not reported | Not reported | Not reported |
| Cycle 3, Day 1 (2-8 Hours) | 26.4 | 14.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.00
- value
- 0.0
- group Id
- OG001
- spread
- 9.16
- value
- 19.4
- group Id
- OG002
- spread
- 7.28
- value
- 10.0
- group Id
- OG003
- spread
- 14.2
- value
- 24.3
- group Id
- OG004
- spread
- 6.06
- value
- 6.8
- group Id
- OG005
- spread
- 14.8
- value
- 26.4
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 27
- group Id
- OG005
- value
- 25
- units
- Participants
- description
- Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Whole blood concentrations of everolimus were measured and concentration data were summarized. The summary statistics at time points with one or more BLQ values were calculated by assigning zero for each BLQ value.
- dispersion Type
- Standard Deviation
- groups
- description
- Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
- id
- OG000
- title
- Cycle 1, Day 1 (0 Hours)
- description
- Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
- id
- OG001
- title
- Cycle 1, Day 1 (2-8 Hours)
- description
- Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
- id
- OG002
- title
- Cycle 2, Day 1 (0 Hours)
- description
- Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
- id
- OG003
- title
- Cycle 2, Day 1 (2-8 Hours)
- description
- Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
- id
- OG004
- title
- Cycle 3, Day 1 (0 Hours)
- description
- Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
- id
- OG005
- title
- Cycle 3, Day 1 (2-8 Hours)
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic analysis set included all participants who received at least one dose of study drug (lenvatinib or everolimus) and had evaluable concentration data.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)
- title
- Summary of Blood Concentrations of Everolimus for Sparse PK Sampling for Phase 1b and Phase 2
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice