TriangleNCT01949532 · OUTCOME
Terminal Half-life (T½) of Metabolite PR-413/M15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- 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. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was \> 20% were excluded.
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 | 13 |
| End Stage Renal Disease | 7 |
Reported measurements
Cycle 1, Day 16 (n = 13, 7)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal Renal Function | 1.07 | Not reported | 0.544 | 1.33 | Not reported |
| End Stage Renal Disease | 1.41 | Not reported | 1.30 | 1.86 | Not reported |
Cycle 2, Day 1 (n = 10, 5)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal Renal Function | 0.962 | Not reported | 0.802 | 1.21 | Not reported |
| End Stage Renal Disease | 1.37 | Not reported | 1.04 | 1.44 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.544
- upper Limit
- 1.33
- value
- 1.07
- group Id
- OG001
- lower Limit
- 1.30
- upper Limit
- 1.86
- value
- 1.41
- title
- Cycle 1, Day 16 (n = 13, 7)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.802
- upper Limit
- 1.21
- value
- 0.962
- group Id
- OG001
- lower Limit
- 1.04
- upper Limit
- 1.44
- value
- 1.37
- title
- Cycle 2, Day 1 (n = 10, 5)
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 7
- units
- Participants
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was \> 20% were excluded.
- 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
- Terminal Half-life (T½) of Metabolite PR-413/M15
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice