NCT04607421 · OUTCOME

SLI, Cohort 2: Ratio of Cmax on Cycle 1 Day 15 as Compared to Cycle 1 Day 1 for 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: NUMBER
Unit: Ratio
Interval / dispersion: 90% Confidence Interval
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. The ratio between geometric LS mean (within Cohort 2) for Cmax on Cycle 1 Day 15 and geometric LS mean (within Cohort 2) for Cmax on Cycle 1 Day 1 for Oxaliplatin has been presented in this outcome measure, which explains the data reported for this outcome measure using measure type as "Number".

Analysis population: The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. 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

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

Reported measurements

Platinum in plasma

Values in Ratio · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
SLI: Cohort 2 [EC + mFOLFOX6]	0.984	Not reported	0.904	1.07	Not reported

Platinum in ultrafiltrate

Values in Ratio · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
SLI: Cohort 2 [EC + mFOLFOX6]	1.11	Not reported	0.940	1.32	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.904
upper Limit
1.07
value
0.984
title
Platinum in plasma
categories
measurements
group Id
OG000
lower Limit
0.940
upper Limit
1.32
value
1.11
title
Platinum in ultrafiltrate

denoms

counts
group Id
OG000
value
15
units
Participants

description

dispersion Type

90% Confidence Interval

groups

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

NUMBER

population Description

The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. 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: Ratio of Cmax on Cycle 1 Day 15 as Compared to Cycle 1 Day 1 for Oxaliplatin

type

SECONDARY

unit Of Measure

Ratio

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

Preserved source evidence · Not medical advice