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NCT04607421 · OUTCOME

SLI: Maximum Plasma Concentration (Cmax) of Encorafenib and Its Metabolite LHY746

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 hour [hr]), 0.75, 1.5, 2.5, 3.5, 5.5, 7.5, and 48 hrs post-dose on Day 15 of Cycle 1; Cohort 2: Pre-dose (0 hr), 1, 2, 3, 4, 6, 8, and 48 hrs post-dose on Days 1 and 15 of Cycle 1

What was measured

Cmax was observed directly from data. LHY746 is a metabolite of Encorafenib.

Analysis population: Pharmacokinetic (PK) parameter analysis set: all enrolled participants treated who had sufficient information to estimate at least 1 of PK parameters of interest and had no major protocol deviations affecting PK assessment. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. Cohort 1 participants did not receive encorafenib until Cycle 1 Day 3, so there was no analysis done at Cycle 1 Day 1.

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.

SLI: Cohort 2 [EC + mFOLFOX6]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes 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 oxaliplatin 85 mg/m\^2 IV infusion for 120 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]23
SLI: Cohort 2 [EC + mFOLFOX6]23

Reported measurements

Encorafenib: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]0
SLI: Cohort 2 [EC + mFOLFOX6]23
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 2 [EC + mFOLFOX6]287095.4Not reportedNot reportedNot reported
LHY746: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]0
SLI: Cohort 2 [EC + mFOLFOX6]23
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 2 [EC + mFOLFOX6]58284.2Not reportedNot reportedNot reported
Encorafenib: Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]23
SLI: Cohort 2 [EC + mFOLFOX6]16
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]297045.8Not reportedNot reportedNot reported
SLI: Cohort 2 [EC + mFOLFOX6]232059.8Not reportedNot reportedNot reported
LHY746: Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]23
SLI: Cohort 2 [EC + mFOLFOX6]16
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]86468.8Not reportedNot reportedNot reported
SLI: Cohort 2 [EC + mFOLFOX6]87382.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        95.4
        value
        2870
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    Encorafenib: Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG001
        spread
        84.2
        value
        582
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    LHY746: Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.8
        value
        2970
      2. group Id
        OG001
        spread
        59.8
        value
        2320
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    Encorafenib: Cycle 1 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        68.8
        value
        864
      2. group Id
        OG001
        spread
        82.3
        value
        873
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    LHY746: Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Cmax was observed directly from data. LHY746 is a metabolite of Encorafenib.
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]
  2. description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes 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 oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG001
    title
    SLI: Cohort 2 [EC + mFOLFOX6]
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) parameter analysis set: all enrolled participants treated who had sufficient information to estimate at least 1 of PK parameters of interest and had no major protocol deviations affecting PK assessment. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. Cohort 1 participants did not receive encorafenib until Cycle 1 Day 3, so there was no analysis done at Cycle 1 Day 1.
reporting Status
POSTED
time Frame
Cohort 1: Pre-dose (0 hour [hr]), 0.75, 1.5, 2.5, 3.5, 5.5, 7.5, and 48 hrs post-dose on Day 15 of Cycle 1; Cohort 2: Pre-dose (0 hr), 1, 2, 3, 4, 6, 8, and 48 hrs post-dose on Days 1 and 15 of Cycle 1
title
SLI: Maximum Plasma Concentration (Cmax) of Encorafenib and Its Metabolite LHY746
type
SECONDARY
unit Of Measure
Nanograms per milliliter

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Preserved source evidence · Not medical advice