TriangleNCT03194867 · OUTCOME
Phase 1 and 2: Plasma Concentration Observed at the End of IV Infusion (Ceoi) of Isatuximab Alone and in Combination With Cemiplimab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- microgram (mcg)/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- At end of infusion (EOI) on Cycle 1 Day 1
What was measured
Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Ceoi. It was calculated using non-compartmental analysis (NCA) after the first administration in Cycle 1. The PK population was defined independently for isatuximab and cemiplimab and consisted of all participants from the all-treated (AT) population with at least 1 available concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times.
Analysis population: Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms.
Groups in this outcome
Phase 2: Isatuximab
Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab
All participants who received isatuximab in combination with cemiplimab were included in this arm.
| Group | Source count |
|---|---|
| Phase 2: Isatuximab | 10 |
| Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Isatuximab | 255 | 72.1 | Not reported | Not reported | Not reported |
| Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab | 239 | 67.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 72.1
- value
- 255
- group Id
- OG001
- spread
- 67.7
- value
- 239
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Ceoi. It was calculated using non-compartmental analysis (NCA) after the first administration in Cycle 1. The PK population was defined independently for isatuximab and cemiplimab and consisted of all participants from the all-treated (AT) population with at least 1 available concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
- id
- OG000
- title
- Phase 2: Isatuximab
- description
- All participants who received isatuximab in combination with cemiplimab were included in this arm.
- id
- OG001
- title
- Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab
- param Type
- MEAN
- population Description
- Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms.
- reporting Status
- POSTED
- time Frame
- At end of infusion (EOI) on Cycle 1 Day 1
- title
- Phase 1 and 2: Plasma Concentration Observed at the End of IV Infusion (Ceoi) of Isatuximab Alone and in Combination With Cemiplimab
- type
- SECONDARY
- unit Of Measure
- microgram (mcg)/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice