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NCT01283516 · OUTCOME

Secondary Pharmacokinetics (PK) Parameter: CL/F

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase · Source last updated 2019-03-15

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

Measure
GEOMETRIC_MEAN
Unit
Litres/hour
Interval / dispersion
Geometric Coefficient of Variation
Time frame
PK Run-in dose escalation phase

What was measured

CL/F is the apparent total body clearance of drug from the plasma

Analysis population: Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \& had at least 1 evaluable PK sample

Groups in this outcome

LDK378 50 mg

Participants receiving 50 mg of LDK378

LDK378 100 mg

Participants receiving 100 mg of LDK378

LDK378 200 mg

Participants receiving 200 mg of LDK378

LDK378 300 mg

Participants receiving 300 mg of LDK378

LDK378 400 mg

Participants receiving 400 mg of LDK378

LDK378 500 mg

Participants receiving 500 mg of LDK378

LDK378 600 mg

Participants receiving 600 mg of LDK378

LDK378 700 mg

Participants receiving 700 mg of LDK378

LDK378 750 mg

Participants receiving 750 mg of LDK378.

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

Analysis denominator · Participants

GroupSource count
LDK378 50 mg1
LDK378 100 mg1
LDK378 200 mg1
LDK378 300 mg2
LDK378 400 mg5
LDK378 500 mg3
LDK378 600 mg2
LDK378 700 mg2
LDK378 750 mg3

Reported measurements

Source class 1
Values in Litres/hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg126NANot reportedNot reportedN/A = not estimable
LDK378 100 mg116NANot reportedNot reportedN/A = not estimable
LDK378 200 mg77.5NANot reportedNot reportedN/A = not estimable
LDK378 300 mg44.536.8Not reportedNot reportedNot reported
LDK378 400 mg95.958.6Not reportedNot reportedNot reported
LDK378 500 mg147.0170.3Not reportedNot reportedNot reported
LDK378 600 mg46.39.6Not reportedNot reportedNot reported
LDK378 700 mg66.635.8Not reportedNot reportedNot reported
LDK378 750 mg88.5162.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N/A = not estimable
        group Id
        OG000
        spread
        NA
        value
        126
      2. comment
        N/A = not estimable
        group Id
        OG001
        spread
        NA
        value
        116
      3. comment
        N/A = not estimable
        group Id
        OG002
        spread
        NA
        value
        77.5
      4. group Id
        OG003
        spread
        36.8
        value
        44.5
      5. group Id
        OG004
        spread
        58.6
        value
        95.9
      6. group Id
        OG005
        spread
        170.3
        value
        147.0
      7. group Id
        OG006
        spread
        9.6
        value
        46.3
      8. group Id
        OG007
        spread
        35.8
        value
        66.6
      9. group Id
        OG008
        spread
        162.5
        value
        88.5
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      2
    8. group Id
      OG007
      value
      2
    9. group Id
      OG008
      value
      3
    units
    Participants
description
CL/F is the apparent total body clearance of drug from the plasma
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants receiving 50 mg of LDK378
    id
    OG000
    title
    LDK378 50 mg
  2. description
    Participants receiving 100 mg of LDK378
    id
    OG001
    title
    LDK378 100 mg
  3. description
    Participants receiving 200 mg of LDK378
    id
    OG002
    title
    LDK378 200 mg
  4. description
    Participants receiving 300 mg of LDK378
    id
    OG003
    title
    LDK378 300 mg
  5. description
    Participants receiving 400 mg of LDK378
    id
    OG004
    title
    LDK378 400 mg
  6. description
    Participants receiving 500 mg of LDK378
    id
    OG005
    title
    LDK378 500 mg
  7. description
    Participants receiving 600 mg of LDK378
    id
    OG006
    title
    LDK378 600 mg
  8. description
    Participants receiving 700 mg of LDK378
    id
    OG007
    title
    LDK378 700 mg
  9. description
    Participants receiving 750 mg of LDK378.
    id
    OG008
    title
    LDK378 750 mg
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \& had at least 1 evaluable PK sample
reporting Status
POSTED
time Frame
PK Run-in dose escalation phase
title
Secondary Pharmacokinetics (PK) Parameter: CL/F
type
SECONDARY
unit Of Measure
Litres/hour

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Preserved source evidence · Not medical advice