TriangleNCT02812706 · OUTCOME
Phase 1: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-week) After First Infusion of Isatuximab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- micrograms*hours per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)
What was measured
AUC was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval.
Analysis population: Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.
Groups in this outcome
Phase 1, Cohort 1: Isatuximab 10 mg/kg
Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
Phase 1, Cohort 2: Isatuximab 20 mg/kg
Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
| Group | Source count |
|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 3 |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 9300 | 3010 | Not reported | Not reported | Not reported |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 21300 | 5520 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3010
- value
- 9300
- group Id
- OG001
- spread
- 5520
- value
- 21300
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- AUC was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
- id
- OG000
- title
- Phase 1, Cohort 1: Isatuximab 10 mg/kg
- description
- Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
- id
- OG001
- title
- Phase 1, Cohort 2: Isatuximab 20 mg/kg
- param Type
- MEAN
- population Description
- Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)
- title
- Phase 1: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-week) After First Infusion of Isatuximab
- type
- SECONDARY
- unit Of Measure
- micrograms*hours per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice