TriangleNCT01677858 · OUTCOME
Volume of Distribution Observed at Steady State (Vss) for Carfilzomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- liters
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Analysis population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Groups in this outcome
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
| Group | Source count |
|---|---|
| Carfilzomib 20 mg/m² | 24 |
| Carfilzomib 70 mg/m² | 16 |
| Carfilzomib 88 mg/m² | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib 20 mg/m² | 17.0 | 133.3 | Not reported | Not reported | Not reported |
| Carfilzomib 70 mg/m² | 14.2 | 54.2 | Not reported | Not reported | Not reported |
| Carfilzomib 88 mg/m² | 7.87 | 78.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 133.3
- value
- 17.0
- group Id
- OG001
- spread
- 54.2
- value
- 14.2
- group Id
- OG002
- spread
- 78.4
- value
- 7.87
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 4
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
- id
- OG000
- title
- Carfilzomib 20 mg/m²
- description
- Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
- id
- OG001
- title
- Carfilzomib 70 mg/m²
- description
- Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
- id
- OG002
- title
- Carfilzomib 88 mg/m²
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
- reporting Status
- POSTED
- time Frame
- Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
- title
- Volume of Distribution Observed at Steady State (Vss) for Carfilzomib
- type
- SECONDARY
- unit Of Measure
- liters
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice