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NCT04607421 · OUTCOME

SLI, Cohort 2: Cmax of Oxaliplatin

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 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. Oxaliplatin was evaluated as total platinum in plasma and platinum in plasma ultrafiltrate.

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 oxaliplatin in Cohort 2 of SLI, hence data is reported only for Cohort 2 and not for Cohort 1.

Groups in this outcome

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 2 [EC + mFOLFOX6]25

Reported measurements

Platinum in plasma: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
SLI: Cohort 2 [EC + mFOLFOX6]25
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 2 [EC + mFOLFOX6]240017.1Not reportedNot reportedNot reported
Platinum in plasma-ultrafiltrate: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
SLI: Cohort 2 [EC + mFOLFOX6]25
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 2 [EC + mFOLFOX6]63640.7Not reportedNot reportedNot reported
Platinum in plasma: Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
SLI: Cohort 2 [EC + mFOLFOX6]17
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 2 [EC + mFOLFOX6]242016.3Not reportedNot reportedNot reported
Platinum in plasma-ultrafiltrate: Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
SLI: Cohort 2 [EC + mFOLFOX6]17
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SLI: Cohort 2 [EC + mFOLFOX6]69732.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.1
        value
        2400
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    Platinum in plasma: Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.7
        value
        636
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    Platinum in plasma-ultrafiltrate: Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.3
        value
        2420
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Platinum in plasma: Cycle 1 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.5
        value
        697
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Platinum in plasma-ultrafiltrate: Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Cmax was observed directly from data. Oxaliplatin was evaluated as total platinum in plasma and platinum in plasma ultrafiltrate.
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 oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG000
    title
    SLI: Cohort 2 [EC + mFOLFOX6]
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 oxaliplatin in Cohort 2 of SLI, hence data is reported only for Cohort 2 and not for Cohort 1.
reporting Status
POSTED
time Frame
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, Cohort 2: Cmax of Oxaliplatin
type
SECONDARY
unit Of Measure
Nanograms per milliliter

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Preserved source evidence · Not medical advice