TriangleNCT04607421 · OUTCOME
SLI, Cohort 1: Ratio of AUCinf 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
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. The ratio between geometric least square (LS) mean (within Cohort 1) for AUCinf on Cycle 1 Day 15 and geometric LS mean (within Cohort 1) for AUCinf 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. Here, "Number Analyzed" signifies participants evaluable for specified rows. 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] | 20 |
Reported measurements
Irinotecan
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 20 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 0.746 | Not reported | 0.697 | 0.798 | Not reported |
SN-38
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 0.581 | Not reported | 0.453 | 0.745 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.697
- upper Limit
- 0.798
- value
- 0.746
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- title
- Irinotecan
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.453
- upper Limit
- 0.745
- value
- 0.581
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- title
- SN-38
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- AUCinf was calculated as AUClast + (Clast\*/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. The ratio between geometric least square (LS) mean (within Cohort 1) for AUCinf on Cycle 1 Day 15 and geometric LS mean (within Cohort 1) for AUCinf 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. Here, "Number Analyzed" signifies participants evaluable for specified rows. 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 AUCinf 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
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Preserved source evidence · Not medical advice