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NCT02928224 · OUTCOME

(Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Encorafenib

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
Liter/hour
Interval / dispersion
95% Confidence Interval
Time frame
2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)

What was measured

The reported cross-arm CL/F value is a fixed-effect parameter determined from a population PK analysis. The analysis included pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register.

Analysis population: The analysis set included all participants in the PK set with measurable plasma concentrations of the test drug plus concentrations from subjects from 4 additional clinical studies. Participants were analyzed according to the actual treatment and dose received.

Groups in this outcome

Pharmacokinetic Population of Encorafenib

Encorafenib + binimetinib + cetuximab. Encorafenib + cetuximab. Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Pharmacokinetic Population of Encorafenib394

Reported measurements

Source class 1
Values in Liter/hour · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pharmacokinetic Population of Encorafenib16.4Not reported14.917.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.9
        upper Limit
        17.5
        value
        16.4
denoms
  1. counts
    1. group Id
      OG000
      value
      394
    units
    Participants
description
The reported cross-arm CL/F value is a fixed-effect parameter determined from a population PK analysis. The analysis included pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register.
dispersion Type
95% Confidence Interval
groups
  1. description
    Encorafenib + binimetinib + cetuximab. Encorafenib + cetuximab. Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.
    id
    OG000
    title
    Pharmacokinetic Population of Encorafenib
param Type
GEOMETRIC_MEAN
population Description
The analysis set included all participants in the PK set with measurable plasma concentrations of the test drug plus concentrations from subjects from 4 additional clinical studies. Participants were analyzed according to the actual treatment and dose received.
reporting Status
POSTED
time Frame
2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)
title
(Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Encorafenib
type
SECONDARY
unit Of Measure
Liter/hour

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

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