TriangleNCT03194867 · OUTCOME
Phase 1 and 2: Maximum Observed Concentration (Cmax) 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
- mcg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- At start of infusion (SOI), EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
What was measured
Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Cmax. It was calculated using NCA after the first administration in Cycle 1.
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 | 264 | 68.0 | Not reported | Not reported | Not reported |
| Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab | 247 | 65.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 68.0
- value
- 264
- group Id
- OG001
- spread
- 65.9
- value
- 247
- 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 Cmax. It was calculated using NCA after the first administration in Cycle 1.
- 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 start of infusion (SOI), EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
- title
- Phase 1 and 2: Maximum Observed Concentration (Cmax) of Isatuximab Alone and in Combination With Cemiplimab
- type
- SECONDARY
- unit Of Measure
- mcg/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice