NCT04607421 · OUTCOME
SLI, Cohort 1: AUClast of Irinotecan and Its Metabolite SN-38
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Nanogram*hour per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- 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. SN-38 is a metabolite of Irinotecan.
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 at specified timepoints. 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 28 |
|---|
Reported measurements
Irinotecan: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 28 |
|---|
Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 11000 | 35.4 | Not reported | Not reported | Not reported |
|---|
SN-38: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 28 |
|---|
Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 225 | 119 | Not reported | Not reported | Not reported |
|---|
Irinotecan: Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 24 |
|---|
Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 8180 | 45.6 | Not reported | Not reported | Not reported |
|---|
SN-38: Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 24 |
|---|
Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 145 | 98.3 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 35.4
- value
- 11000
- title
- Irinotecan: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 119
- value
- 225
- title
- SN-38: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 45.6
- value
- 8180
- title
- Irinotecan: Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 98.3
- value
- 145
- title
- SN-38: Cycle 1 Day 15
- 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. SN-38 is a metabolite of Irinotecan.
- dispersion Type
- Geometric Coefficient of Variation
- 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
- GEOMETRIC_MEAN
- 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 at specified timepoints. 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: AUClast of Irinotecan and Its Metabolite SN-38
- type
- SECONDARY
- unit Of Measure
- Nanogram*hour per milliliter
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