TriangleNCT03275285 · OUTCOME
Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Carfilzomib: Primary Analysis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Liters
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
What was measured
Volume of Distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Analysis population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Groups in this outcome
Isatuximab + Carfilzomib + Dexamethasone (IKd)
Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
| Group | Source count |
|---|---|
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 453 | 1570 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1570
- value
- 453
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- Volume of Distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
- id
- OG000
- title
- Isatuximab + Carfilzomib + Dexamethasone (IKd)
- param Type
- MEAN
- population Description
- Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
- title
- Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Carfilzomib: Primary Analysis
- type
- SECONDARY
- unit Of Measure
- Liters
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice