NCT04607421 · OUTCOME

Phase 3: AUCtau of Encorafenib and Its Metabolite LHY746 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: Nanogram*hour per milliliter
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

AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval. tau = 24 hrs for QD dosing of encorafenib. LHY746 is a metabolite of encorafenib.

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

Group	Source count
Phase 3: Arm A [EC]	11

Reported measurements

Encorafenib: Cycle 1 Day 1

Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	26800	47	Not reported	Not reported	Not reported

LHY746: Cycle 1 Day 1

Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	11900	65.5	Not reported	Not reported	Not reported

Encorafenib: Cycle 1 Day 15

Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	11100	32.2	Not reported	Not reported	Not reported

LHY746: Cycle 1 Day 15

Values in Nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	11300	103	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
47
value
26800
title
Encorafenib: Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
65.5
value
11900
title
LHY746: Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
32.2
value
11100
title
Encorafenib: Cycle 1 Day 15
categories
measurements
group Id
OG000
spread
103
value
11300
title
LHY746: Cycle 1 Day 15

denoms

counts
group Id
OG000
value
11
units
Participants

description

AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval. tau = 24 hrs for QD dosing of encorafenib. LHY746 is a metabolite of encorafenib.

dispersion Type

Geometric Coefficient of Variation

groups

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: AUCtau of Encorafenib and Its Metabolite LHY746 in Mainland China Participants

type

SECONDARY

unit Of Measure

Nanogram*hour per milliliter

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

Preserved source evidence · Not medical advice