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NCT01283516 · OUTCOME

Primary Pharmacokinetics (PK) Parameter: AUC0-24h

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
ng*h/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases

What was measured

Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. AUC0 - 24 is the AUC calculated to 24 hour. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter AUC0-24.

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 mg2
LDK378 100 mg2
LDK378 200 mg3
LDK378 300 mg3
LDK378 400 mg14
LDK378 500 mg10
LDK378 600 mg10
LDK378 700 mg5
LDK378 750 mg252

Reported measurements

PK Run-in dose escalation phase

Analysis denominator · Participants

GroupSource count
LDK378 50 mg1
LDK378 100 mg2
LDK378 200 mg2
LDK378 300 mg3
LDK378 400 mg12
LDK378 500 mg8
LDK378 600 mg9
LDK378 700 mg4
LDK378 750 mg10
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg226NANot reportedNot reportedN/A = not estimable
LDK378 100 mg46710.7Not reportedNot reportedNot reported
LDK378 200 mg70355.6Not reportedNot reportedNot reported
LDK378 300 mg344044.7Not reportedNot reportedNot reported
LDK378 400 mg192078.0Not reportedNot reportedNot reported
LDK378 500 mg235087.9Not reportedNot reportedNot reported
LDK378 600 mg359053.4Not reportedNot reportedNot reported
LDK378 700 mg3450137.9Not reportedNot reportedNot reported
LDK378 750 mg3390121.4Not reportedNot reportedNot reported
C1D8: dose escalation phase

Analysis denominator · Participants

GroupSource count
LDK378 50 mg2
LDK378 100 mg2
LDK378 200 mg3
LDK378 300 mg2
LDK378 400 mg9
LDK378 500 mg9
LDK378 600 mg7
LDK378 700 mg2
LDK378 750 mg8
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg43542.1Not reportedNot reportedNot reported
LDK378 100 mg152041.1Not reportedNot reportedNot reported
LDK378 200 mg415032.2Not reportedNot reportedNot reported
LDK378 300 mg7660402.8Not reportedNot reportedNot reported
LDK378 400 mg768077.4Not reportedNot reportedNot reported
LDK378 500 mg1230037.4Not reportedNot reportedNot reported
LDK378 600 mg1470071.7Not reportedNot reportedNot reported
LDK378 700 mg352000.800Not reportedNot reportedNot reported
LDK378 750 mg1390074.8Not reportedNot reportedNot reported
C1D1 dose escalation phase for 750mg

Analysis denominator · Participants

GroupSource count
LDK378 50 mg0
LDK378 100 mg0
LDK378 200 mg0
LDK378 300 mg0
LDK378 400 mg0
LDK378 500 mg0
LDK378 600 mg0
LDK378 700 mg0
LDK378 750 mg73
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 750 mg3340111.9Not reportedNot reportedNot reported
C2D1 dose escalation & expansion phases

Analysis denominator · Participants

GroupSource count
LDK378 50 mg1
LDK378 100 mg1
LDK378 200 mg0
LDK378 300 mg0
LDK378 400 mg0
LDK378 500 mg0
LDK378 600 mg0
LDK378 700 mg0
LDK378 750 mg23
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg376NANot reportedNot reportedN/A = not estimable
LDK378 100 mg894NANot reportedNot reportedN/A = not estimable
LDK378 750 mg2260037.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N/A = not estimable
        group Id
        OG000
        spread
        NA
        value
        226
      2. group Id
        OG001
        spread
        10.7
        value
        467
      3. group Id
        OG002
        spread
        55.6
        value
        703
      4. group Id
        OG003
        spread
        44.7
        value
        3440
      5. group Id
        OG004
        spread
        78.0
        value
        1920
      6. group Id
        OG005
        spread
        87.9
        value
        2350
      7. group Id
        OG006
        spread
        53.4
        value
        3590
      8. group Id
        OG007
        spread
        137.9
        value
        3450
      9. group Id
        OG008
        spread
        121.4
        value
        3390
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        8
      7. group Id
        OG006
        value
        9
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        10
      units
      Participants
    title
    PK Run-in dose escalation phase
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.1
        value
        435
      2. group Id
        OG001
        spread
        41.1
        value
        1520
      3. group Id
        OG002
        spread
        32.2
        value
        4150
      4. group Id
        OG003
        spread
        402.8
        value
        7660
      5. group Id
        OG004
        spread
        77.4
        value
        7680
      6. group Id
        OG005
        spread
        37.4
        value
        12300
      7. group Id
        OG006
        spread
        71.7
        value
        14700
      8. group Id
        OG007
        spread
        0.800
        value
        35200
      9. group Id
        OG008
        spread
        74.8
        value
        13900
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        7
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        8
      units
      Participants
    title
    C1D8: dose escalation phase
  3. categories
    1. measurements
      1. group Id
        OG008
        spread
        111.9
        value
        3340
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        73
      units
      Participants
    title
    C1D1 dose escalation phase for 750mg
  4. categories
    1. measurements
      1. comment
        N/A = not estimable
        group Id
        OG000
        spread
        NA
        value
        376
      2. comment
        N/A = not estimable
        group Id
        OG001
        spread
        NA
        value
        894
      3. group Id
        OG008
        spread
        37.1
        value
        22600
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        23
      units
      Participants
    title
    C2D1 dose escalation & expansion phases
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      14
    6. group Id
      OG005
      value
      10
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      5
    9. group Id
      OG008
      value
      252
    units
    Participants
description
Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. AUC0 - 24 is the AUC calculated to 24 hour. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter AUC0-24.
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 of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
title
Primary Pharmacokinetics (PK) Parameter: AUC0-24h
type
SECONDARY
unit Of Measure
ng*h/mL

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Preserved source evidence · Not medical advice