TriangleNCT04607421 · OUTCOME
SLI, Cohort 1: Ratio of AUClast on Cycle 1 Day 15 as Compared to Cycle 1 Day 1 for Irinotecan and Its Metabolite SN-38
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Ratio
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Cohort 1: Pre-dose (0 hr), 0.75, 1.5, 2.5, 3.5, 5.5, 7.5, and 48 hrs post-dose on Days 1 and 15 of Cycle 1
What was measured
AUClast was defined as area under the plasma concentration time curve from time zero to the last measurable concentration. AUClast was calculated using linear/log trapezoidal method. The ratio between geometric LS mean (within Cohort 1) for AUClast on Cycle 1 Day 15 and geometric LS mean (within Cohort 1) for AUClast on Cycle 1 Day 1 for irinotecan and its metabolite SN-38 has been presented in this outcome measure, which explains the data reported for this outcome measure using measure type as "Number".
Analysis population: The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants received irinotecan in Cohort 1 of SLI, hence data is reported only for Cohort 1 and not for Cohort 2.
Groups in this outcome
SLI: Cohort 1 [EC + FOLFIRI]
Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 24 |
Reported measurements
Irinotecan
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 0.76 | Not reported | 0.675 | 0.856 | Not reported |
SN-38
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 0.723 | Not reported | 0.565 | 0.926 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.675
- upper Limit
- 0.856
- value
- 0.76
- title
- Irinotecan
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.565
- upper Limit
- 0.926
- value
- 0.723
- title
- SN-38
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- description
- AUClast was defined as area under the plasma concentration time curve from time zero to the last measurable concentration. AUClast was calculated using linear/log trapezoidal method. The ratio between geometric LS mean (within Cohort 1) for AUClast on Cycle 1 Day 15 and geometric LS mean (within Cohort 1) for AUClast on Cycle 1 Day 1 for irinotecan and its metabolite SN-38 has been presented in this outcome measure, which explains the data reported for this outcome measure using measure type as "Number".
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- SLI: Cohort 1 [EC + FOLFIRI]
- param Type
- NUMBER
- population Description
- The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants received irinotecan in Cohort 1 of SLI, hence data is reported only for Cohort 1 and not for Cohort 2.
- reporting Status
- POSTED
- time Frame
- Cohort 1: Pre-dose (0 hr), 0.75, 1.5, 2.5, 3.5, 5.5, 7.5, and 48 hrs post-dose on Days 1 and 15 of Cycle 1
- title
- SLI, Cohort 1: Ratio of AUClast on Cycle 1 Day 15 as Compared to Cycle 1 Day 1 for Irinotecan and Its Metabolite SN-38
- type
- SECONDARY
- unit Of Measure
- Ratio
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice