TriangleNCT02546986 · OUTCOME
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of CC-486
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pharmacokinetic (PK) blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1
What was measured
Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as \[AUCt + Ct/ λz\]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC % extrap is ≥25%, AUCi inf was not reported.
Analysis population: The PK population includes participants with evaluable CC-486 plasma PK profile.
Groups in this outcome
CC-486 and Pembrolizumab (CC-486 + PBZ)
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
| Group | Source count |
|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 15 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 156.0 | 82.64 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 212.7 | 78.06 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 82.64
- value
- 156.0
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 78.06
- value
- 212.7
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as \[AUCt + Ct/ λz\]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC % extrap is ≥25%, AUCi inf was not reported.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
- id
- OG000
- title
- CC-486 and Pembrolizumab (CC-486 + PBZ)
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK population includes participants with evaluable CC-486 plasma PK profile.
- reporting Status
- POSTED
- time Frame
- Pharmacokinetic (PK) blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1
- title
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of CC-486
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice