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NCT04607421 · OUTCOME

Phase 3: CL/F of Encorafenib in Mainland China Participants

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
Liters per hour
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose (0 hr), 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hrs post-dose on Days 1 and 15 of Cycle 1

What was measured

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by area under the concentration curve from time 0 extrapolated to infinite time (AUCinf). AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.

Analysis population: The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. As pre-specified in the protocol of the study, 12 PK evaluable participants in mainland China were randomized in Arm A, no additional participants were required from Arm B and participants did not receive encorafenib in Arm C. Hence, data is reported only for Arm A and not for Arms B and C.

Groups in this outcome

Phase 3: Arm A [EC]

Participants received encorafenib 300 mg QD orally and cetuximab 500 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
Phase 3: Arm A [EC]11

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Phase 3: Arm A [EC]9
Values in Liters per hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]11.453.3Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Phase 3: Arm A [EC]11
Values in Liters per hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]2732.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.3
        value
        11.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.3
        value
        27
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by area under the concentration curve from time 0 extrapolated to infinite time (AUCinf). AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
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. Participants received treatment in 28-day cycles.
    id
    OG000
    title
    Phase 3: Arm A [EC]
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. As pre-specified in the protocol of the study, 12 PK evaluable participants in mainland China were randomized in Arm A, no additional participants were required from Arm B and participants did not receive encorafenib in Arm C. Hence, data is reported only for Arm A and not for Arms B and C.
reporting Status
POSTED
time Frame
Pre-dose (0 hr), 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hrs post-dose on Days 1 and 15 of Cycle 1
title
Phase 3: CL/F of Encorafenib in Mainland China Participants
type
SECONDARY
unit Of Measure
Liters per hour

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

Preserved source evidence · Not medical advice