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NCT02414139 · OUTCOME

Pharmacokinetic (PK) Concentrations 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
MEAN
Unit
nanogram/mililiter (ng/ml)
Interval / dispersion
Standard Deviation
Time frame
Cycle (C) 1 Day (D) 1 predose and 2 hours post-dose, C1D15 pre-dose and 2 hours post-dose, C3D1 pre-dose. Each Cycle is 21 days

What was measured

PK concentrations of capmatinib. Plasma concentrations of capmatinib were measured using validated liquid chromatography-tandem mass spectrometry (LCMS/MS) methods with a lower limit of quantification (LLOQ) of approximately 1.0 ng/mL. Capmatinib concentration data was summarized for Cohorts 1a, 1b, 2, 3, 4, 5a and 5b when capmatinib was administered in fasted state; and for Cohorts 6 and 7 when capmatinib was administered with or without food.

Analysis population: Participants who received at least one dose of capmatinib and provided at least one evaluable pharmacokinetic concentration for capmatinib at the specified time points. Participants who received capmatinib under the same administration conditions (fasted state or with/without food) were pooled together.

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

Cohorts 6-7: Capmatinib Administration With ot Without Food

Participants from Cohorts 6 and 7 who received capmatinib with or without food

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 State275
Cohorts 6-7: Capmatinib Administration With ot Without Food54

Reported measurements

Cycle 1 Day 1- pre-dose

Analysis denominator · Participants

GroupSource count
Cohorts 1-5: Capmatinib Administration in Fasted State275
Cohorts 6-7: Capmatinib Administration With ot Without Food54
Values in nanogram/mililiter (ng/ml) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohorts 1-5: Capmatinib Administration in Fasted State0.000.00Not reportedNot reportedNot reported
Cohorts 6-7: Capmatinib Administration With ot Without Food0.000.00Not reportedNot reportedNot reported
Cycle 1 Day 1- 2 hours post-dose

Analysis denominator · Participants

GroupSource count
Cohorts 1-5: Capmatinib Administration in Fasted State275
Cohorts 6-7: Capmatinib Administration With ot Without Food53
Values in nanogram/mililiter (ng/ml) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohorts 1-5: Capmatinib Administration in Fasted State33601920Not reportedNot reportedNot reported
Cohorts 6-7: Capmatinib Administration With ot Without Food30601780Not reportedNot reportedNot reported
Cycle 1 Day 15 - pre-dose

Analysis denominator · Participants

GroupSource count
Cohorts 1-5: Capmatinib Administration in Fasted State176
Cohorts 6-7: Capmatinib Administration With ot Without Food29
Values in nanogram/mililiter (ng/ml) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohorts 1-5: Capmatinib Administration in Fasted State727781Not reportedNot reportedNot reported
Cohorts 6-7: Capmatinib Administration With ot Without Food663806Not reportedNot reportedNot reported
Cycle 1 Day 15- 2 hours post-dose

Analysis denominator · Participants

GroupSource count
Cohorts 1-5: Capmatinib Administration in Fasted State209
Cohorts 6-7: Capmatinib Administration With ot Without Food47
Values in nanogram/mililiter (ng/ml) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohorts 1-5: Capmatinib Administration in Fasted State41002100Not reportedNot reportedNot reported
Cohorts 6-7: Capmatinib Administration With ot Without Food43402000Not reportedNot reportedNot reported
Cycle 3 Day 1 - pre-dose

Analysis denominator · Participants

GroupSource count
Cohorts 1-5: Capmatinib Administration in Fasted State96
Cohorts 6-7: Capmatinib Administration With ot Without Food18
Values in nanogram/mililiter (ng/ml) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohorts 1-5: Capmatinib Administration in Fasted State6871000Not reportedNot reportedNot reported
Cohorts 6-7: Capmatinib Administration With ot Without Food672745Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00
        value
        0.00
      2. group Id
        OG001
        spread
        0.00
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        275
      2. group Id
        OG001
        value
        54
      units
      Participants
    title
    Cycle 1 Day 1- pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1920
        value
        3360
      2. group Id
        OG001
        spread
        1780
        value
        3060
    denoms
    1. counts
      1. group Id
        OG000
        value
        275
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    Cycle 1 Day 1- 2 hours post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        781
        value
        727
      2. group Id
        OG001
        spread
        806
        value
        663
    denoms
    1. counts
      1. group Id
        OG000
        value
        176
      2. group Id
        OG001
        value
        29
      units
      Participants
    title
    Cycle 1 Day 15 - pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2100
        value
        4100
      2. group Id
        OG001
        spread
        2000
        value
        4340
    denoms
    1. counts
      1. group Id
        OG000
        value
        209
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Cycle 1 Day 15- 2 hours post-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1000
        value
        687
      2. group Id
        OG001
        spread
        745
        value
        672
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Cycle 3 Day 1 - pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      275
    2. group Id
      OG001
      value
      54
    units
    Participants
description
PK concentrations of capmatinib. Plasma concentrations of capmatinib were measured using validated liquid chromatography-tandem mass spectrometry (LCMS/MS) methods with a lower limit of quantification (LLOQ) of approximately 1.0 ng/mL. Capmatinib concentration data was summarized for Cohorts 1a, 1b, 2, 3, 4, 5a and 5b when capmatinib was administered in fasted state; and for Cohorts 6 and 7 when capmatinib was administered with or without food.
dispersion Type
Standard Deviation
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
  2. description
    Participants from Cohorts 6 and 7 who received capmatinib with or without food
    id
    OG001
    title
    Cohorts 6-7: Capmatinib Administration With ot Without Food
param Type
MEAN
population Description
Participants who received at least one dose of capmatinib and provided at least one evaluable pharmacokinetic concentration for capmatinib at the specified time points. Participants who received capmatinib under the same administration conditions (fasted state or with/without food) were pooled together.
reporting Status
POSTED
time Frame
Cycle (C) 1 Day (D) 1 predose and 2 hours post-dose, C1D15 pre-dose and 2 hours post-dose, C3D1 pre-dose. Each Cycle is 21 days
title
Pharmacokinetic (PK) Concentrations of Capmatinib
type
SECONDARY
unit Of Measure
nanogram/mililiter (ng/ml)

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Preserved source evidence · Not medical advice