NCT02928224 · OUTCOME

(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Cetuximab

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: Nanogram/milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

Analysis population: The PK set included all participants in the Safety Set who had at least 1 post-dose blood collection for PK with associated bioanalytical results. Participants were analyzed according to the actual treatment and dose received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.

Groups in this outcome

Combined Safety Lead-in

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

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
Combined Safety Lead-in	37

Reported measurements

Cycle 1

Analysis denominator · Participants

Group	Source count
Combined Safety Lead-in	34

Values in Nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combined Safety Lead-in	195000	22.2	Not reported	Not reported	Not reported

Cycle 2

Analysis denominator · Participants

Group	Source count
Combined Safety Lead-in	32

Values in Nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combined Safety Lead-in	199000	26.8	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
22.2
value
195000
denoms
counts
group Id
OG000
value
34
units
Participants
title
Cycle 1
categories
measurements
group Id
OG000
spread
26.8
value
199000
denoms
counts
group Id
OG000
value
32
units
Participants
title
Cycle 2

denoms

counts
group Id
OG000
value
37
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
id
OG000
title
Combined Safety Lead-in

param Type

GEOMETRIC_MEAN

population Description

The PK set included all participants in the Safety Set who had at least 1 post-dose blood collection for PK with associated bioanalytical results. Participants were analyzed according to the actual treatment and dose received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.

reporting Status

POSTED

time Frame

Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

title

(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Cetuximab

type

SECONDARY

unit Of Measure

Nanogram/milliliter

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

Preserved source evidence · Independent clinical review pending · Not medical advice