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NCT04607421 · OUTCOME

SLI, Cohort 1: Cmax 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
Nanograms 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

Cmax was observed directly from data. 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

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]28

Reported measurements

Irinotecan: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]28
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]182018.9Not reportedNot reportedNot reported
SN-38: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]28
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]21.949.3Not reportedNot reportedNot reported
Irinotecan: Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]24
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]165026Not reportedNot reportedNot reported
SN-38: Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]24
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]23.960.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.9
        value
        1820
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Irinotecan: Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.3
        value
        21.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    SN-38: Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        26
        value
        1650
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Irinotecan: Cycle 1 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.6
        value
        23.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    SN-38: Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
description
Cmax was observed directly from data. SN-38 is a metabolite of Irinotecan.
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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: Cmax of Irinotecan and Its Metabolite SN-38
type
SECONDARY
unit Of Measure
Nanograms per milliliter

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Preserved source evidence · Not medical advice