NCT04607421 · OUTCOME

Phase 3: Tmax 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: MEDIAN
Unit: Hours
Interval / dispersion: Full Range
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

Tmax: time (hours) to Cmax. 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 Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	2	Not reported	1.02	24	Not reported

LHY746: Cycle 1 Day 1

Values in Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	6.07	Not reported	2	24	Not reported

Encorafenib: Cycle 1 Day 15

Values in Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	2	Not reported	0.533	24	Not reported

LHY746: Cycle 1 Day 15

Values in Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	3	Not reported	1.08	5.1	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.02
upper Limit
24
value
2
title
Encorafenib: Cycle 1 Day 1
categories
measurements
group Id
OG000
lower Limit
2
upper Limit
24
value
6.07
title
LHY746: Cycle 1 Day 1
categories
measurements
group Id
OG000
lower Limit
0.533
upper Limit
24
value
2
title
Encorafenib: Cycle 1 Day 15
categories
measurements
group Id
OG000
lower Limit
1.08
upper Limit
5.1
value
3
title
LHY746: Cycle 1 Day 15

denoms

counts
group Id
OG000
value
11
units
Participants

description

Tmax: time (hours) to Cmax. LHY746 is a metabolite of Encorafenib.

dispersion Type

Full Range

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

MEDIAN

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

type

SECONDARY

unit Of Measure

Hours

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

Preserved source evidence · Not medical advice