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NCT04607421 · OUTCOME

Cohort 3: Trough Plasma Concentration 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
Predose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1

What was measured

Trough plasma concentration of encorafenib and its metabolite LHY746 was measured in this outcome measure.

Analysis population: PK concentration set was defined as all enrolled participants who were treated and had at least 1 analyte concentration. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable at specified timepoints. As pre-specified in the protocol of the study, this outcome measure was planned only for Arm D of Cohort 3. Hence, data is not reported for Arm E.

Groups in this outcome

Cohort 3: Arm D [EC + FOLFIRI]

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 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
Cohort 3: Arm D [EC + FOLFIRI]45

Reported measurements

Encorafenib: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]28
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]NANANot reportedNot reportedGeometric mean and geometric coefficient of variation could not be estimated as none of the observations were above the lower limit of quantification.
Encorafenib: Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]39
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]10.53212Not reportedNot reportedNot reported
Encorafenib: Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]36
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]11.26417Not reportedNot reportedNot reported
Encorafenib: Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]37
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]9.336141Not reportedNot reportedNot reported
Encorafenib: Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]45
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]9.175111Not reportedNot reportedNot reported
Encorafenib: Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]39
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]13.90466Not reportedNot reportedNot reported
LHY746: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]28
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]NANANot reportedNot reportedGeometric mean and geometric coefficient of variation could not be estimated as none of the observations were above the lower limit of quantification.
LHY746: Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]39
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]40.80258Not reportedNot reportedNot reported
LHY746: Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]36
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]33.86250Not reportedNot reportedNot reported
LHY746: Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]37
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]25.85153Not reportedNot reportedNot reported
LHY746: Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]45
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]29.49210Not reportedNot reportedNot reported
LHY746: Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Arm D [EC + FOLFIRI]39
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 3: Arm D [EC + FOLFIRI]43.71271Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Geometric mean and geometric coefficient of variation could not be estimated as none of the observations were above the lower limit of quantification.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Encorafenib: Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        212
        value
        10.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    Encorafenib: Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        417
        value
        11.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Encorafenib: Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        141
        value
        9.336
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Encorafenib: Cycle 4 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        111
        value
        9.175
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Encorafenib: Cycle 5 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        466
        value
        13.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    Encorafenib: Cycle 6 Day 1
  7. categories
    1. measurements
      1. comment
        Geometric mean and geometric coefficient of variation could not be estimated as none of the observations were above the lower limit of quantification.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    LHY746: Cycle 1 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        258
        value
        40.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    LHY746: Cycle 2 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        250
        value
        33.86
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    LHY746: Cycle 3 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        153
        value
        25.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    LHY746: Cycle 4 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        210
        value
        29.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    LHY746: Cycle 5 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        271
        value
        43.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    LHY746: Cycle 6 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Trough plasma concentration of encorafenib and its metabolite LHY746 was measured in this outcome measure.
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG000
    title
    Cohort 3: Arm D [EC + FOLFIRI]
param Type
GEOMETRIC_MEAN
population Description
PK concentration set was defined as all enrolled participants who were treated and had at least 1 analyte concentration. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable at specified timepoints. As pre-specified in the protocol of the study, this outcome measure was planned only for Arm D of Cohort 3. Hence, data is not reported for Arm E.
reporting Status
POSTED
time Frame
Predose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1
title
Cohort 3: Trough Plasma Concentration of Encorafenib and Its Metabolite LHY746
type
SECONDARY
unit Of Measure
Nanograms per milliliter

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Preserved source evidence · Not medical advice