TriangleNCT01949532 · OUTCOME
Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-389/M14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.
Analysis population: PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was \> 20% were excluded. AUC0-∞ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.
Groups in this outcome
Normal Renal Function
Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
End Stage Renal Disease
Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
| Group | Source count |
|---|---|
| Normal Renal Function | 10 |
| End Stage Renal Disease | 0 |
Reported measurements
Cycle 1, Day 16
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal Renal Function | 355 | 25.1 | Not reported | Not reported | Not reported |
Cycle 2, Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal Renal Function | 650 | 22.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 25.1
- value
- 355
- title
- Cycle 1, Day 16
- categories
- measurements
- group Id
- OG000
- spread
- 22.5
- value
- 650
- title
- Cycle 2, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 0
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
- id
- OG000
- title
- Normal Renal Function
- description
- Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
- id
- OG001
- title
- End Stage Renal Disease
- param Type
- GEOMETRIC_MEAN
- population Description
- PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was \> 20% were excluded. AUC0-∞ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.
- reporting Status
- POSTED
- time Frame
- Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.
- title
- Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-389/M14
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice