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NCT02928224 · OUTCOME

(Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) 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 *hour
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 pharmacokinetics (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.

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

GroupSource count
Combined Safety Lead-in37

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
Combined Safety Lead-in34
Values in Nanogram/milliliter *hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combined Safety Lead-in84100022.2Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
Combined Safety Lead-in32
Values in Nanogram/milliliter *hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combined Safety Lead-in97000020.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.2
        value
        841000
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.6
        value
        970000
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    Cycle 2
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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 pharmacokinetics (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.
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 Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Cetuximab
type
SECONDARY
unit Of Measure
Nanogram/milliliter *hour

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

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