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NCT04607421 · OUTCOME

SLI: Area Under the Concentration Time Profile From Time Zero to 6 Hours (AUC6) for 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
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, and 6 hrs post-dose on Day 15 of Cycle 1; Cohort 2: Predose (0 hr), 1, 2, 3, 4, and 6 hrs post-dose on Days 1 and 15 of Cycle 1

What was measured

The AUC was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. LHY746 is a metabolite of Encorafenib.

Analysis population: 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]19
SLI: Cohort 2 [EC + mFOLFOX6]21

Reported measurements

Encorafenib: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]0
SLI: Cohort 2 [EC + mFOLFOX6]21
Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 2 [EC + mFOLFOX6]938097.4Not reportedNot reportedNot reported
LHY746: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]0
SLI: Cohort 2 [EC + mFOLFOX6]21
Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 2 [EC + mFOLFOX6]1640109Not reportedNot reportedNot reported
Encorafenib: Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]19
SLI: Cohort 2 [EC + mFOLFOX6]14
Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]891036.2Not reportedNot reportedNot reported
SLI: Cohort 2 [EC + mFOLFOX6]613049.4Not reportedNot reportedNot reported
LHY746: Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]19
SLI: Cohort 2 [EC + mFOLFOX6]14
Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]340067.9Not reportedNot reportedNot reported
SLI: Cohort 2 [EC + mFOLFOX6]2820123Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        97.4
        value
        9380
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    Encorafenib: Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG001
        spread
        109
        value
        1640
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    LHY746: Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.2
        value
        8910
      2. group Id
        OG001
        spread
        49.4
        value
        6130
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    Encorafenib: Cycle 1 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.9
        value
        3400
      2. group Id
        OG001
        spread
        123
        value
        2820
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    LHY746: Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      21
    units
    Participants
description
The AUC was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. 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
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 hr), 0.75, 1.5, 2.5, 3.5, 5.5, and 6 hrs post-dose on Day 15 of Cycle 1; Cohort 2: Predose (0 hr), 1, 2, 3, 4, and 6 hrs post-dose on Days 1 and 15 of Cycle 1
title
SLI: Area Under the Concentration Time Profile From Time Zero to 6 Hours (AUC6) for Encorafenib and Its Metabolite LHY746
type
SECONDARY
unit Of Measure
Nanogram*hour per milliliter

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice