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NCT02414139 · OUTCOME

Time to Reach Maximum Concentration (Tmax) of Capmatinib

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1) · Source last updated 2024-03-20

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

Measure
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days

What was measured

Tmax of capmatinib was estimated by non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL. Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis

Analysis population: Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (Tmax for capmatinib) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis

Groups in this outcome

Cohorts 1-5: Capmatinib Administration in Fasted State

Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state

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

Analysis denominator · Participants

GroupSource count
Cohorts 1-5: Capmatinib Administration in Fasted State55

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Cohorts 1-5: Capmatinib Administration in Fasted State55
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohorts 1-5: Capmatinib Administration in Fasted State1.87Not reported0.5834.03Not reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Cohorts 1-5: Capmatinib Administration in Fasted State44
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohorts 1-5: Capmatinib Administration in Fasted State1.09Not reported0.56.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.583
        upper Limit
        4.03
        value
        1.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        6.07
        value
        1.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      units
      Participants
    title
    Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
Tmax of capmatinib was estimated by non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL. Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
dispersion Type
Full Range
groups
  1. description
    Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
    id
    OG000
    title
    Cohorts 1-5: Capmatinib Administration in Fasted State
param Type
MEDIAN
population Description
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (Tmax for capmatinib) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
reporting Status
POSTED
time Frame
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
title
Time to Reach Maximum Concentration (Tmax) of Capmatinib
type
SECONDARY
unit Of Measure
hour

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

Preserved source evidence · Not medical advice