TriangleNCT03194867 · OUTCOME
Phase 1 and 2: Last Concentration Observed Above the Lower Limit of Quantitation (Clast) 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 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 Clast. 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 | 85.7 | 44.9 | Not reported | Not reported | Not reported |
| Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab | 64.1 | 32.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 44.9
- value
- 85.7
- group Id
- OG001
- spread
- 32.1
- value
- 64.1
- 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 Clast. 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 SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
- title
- Phase 1 and 2: Last Concentration Observed Above the Lower Limit of Quantitation (Clast) of Isatuximab Alone and in Combination With Cemiplimab
- type
- SECONDARY
- unit Of Measure
- mcg/mL
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Preserved source evidence · Not medical advice