NCT04607421 · OUTCOME

SLI: Apparent Total Clearance (CL/F) of Encorafenib

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: Cohort 1: Pre-dose (0 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

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/AUCinf where dose is the 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 last plasma concentration from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Analysis population: PK parameter analysis set analyzed. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. For Cohort 2, Number Analyzed=0 on Cycle 1 Day 1 indicated there was no PK sample at end of dosing interval and kel could not be extrapolated to calculate CL/F on 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

Group	Source count
SLI: Cohort 1 [EC + FOLFIRI]	23
SLI: Cohort 2 [EC + mFOLFOX6]	15

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
SLI: Cohort 1 [EC + FOLFIRI]	0
SLI: Cohort 2 [EC + mFOLFOX6]	0

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
SLI: Cohort 1 [EC + FOLFIRI]	23
SLI: Cohort 2 [EC + mFOLFOX6]	15

Values in Liters per hour · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
SLI: Cohort 1 [EC + FOLFIRI]	23	37.1	Not reported	Not reported	Not reported
SLI: Cohort 2 [EC + mFOLFOX6]	32.7	28.1	Not reported	Not reported	Not reported

Complete source fields

classes

denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
37.1
value
23
group Id
OG001
spread
28.1
value
32.7
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
15
units
Participants
title
Cycle 1 Day 15

denoms

counts
group Id
OG000
value
23
group Id
OG001
value
15
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

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]
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 analyzed. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. For Cohort 2, Number Analyzed=0 on Cycle 1 Day 1 indicated there was no PK sample at end of dosing interval and kel could not be extrapolated to calculate CL/F on 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, 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: Apparent Total Clearance (CL/F) of Encorafenib

type

SECONDARY

unit Of Measure

Liters per hour

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

Preserved source evidence · Not medical advice