TriangleNCT01041404 · OUTCOME
Steady State Trastuzumab Area Under the Concentration (AUC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- mg*day/L
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106
What was measured
Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by \[\*\] day per liter \[L\]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.
Analysis population: Pharmacokinetic (PK) population: all participants with at least 1 measurement of trastuzumab serum concentration associated with a documented trastuzumab dosing history.
Groups in this outcome
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
| Group | Source count |
|---|---|
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 266 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 1030 | Not reported | 565 | 1726 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 565
- upper Limit
- 1726
- value
- 1030
- denoms
- counts
- group Id
- OG000
- value
- 266
- units
- Participants
- description
- Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by \[\*\] day per liter \[L\]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
- id
- OG000
- title
- Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
- param Type
- MEDIAN
- population Description
- Pharmacokinetic (PK) population: all participants with at least 1 measurement of trastuzumab serum concentration associated with a documented trastuzumab dosing history.
- reporting Status
- POSTED
- time Frame
- Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106
- title
- Steady State Trastuzumab Area Under the Concentration (AUC)
- type
- SECONDARY
- unit Of Measure
- mg*day/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice