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NCT01283516 · OUTCOME

Primary Pharmacokinetics (PK) Parameter: Cmax

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/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 ion phase, Cycle 2 Day 1 of dose escalation & expansion phases

What was measured

Cmax is the maximum observed concentration. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Cmax.

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/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg13.1NANot reportedNot reportedN/A = not estimable
LDK378 100 mg29.310.1Not reportedNot reportedNot reported
LDK378 200 mg40.288.5Not reportedNot reportedNot reported
LDK378 300 mg19841.5Not reportedNot reportedNot reported
LDK378 400 mg12080.9Not reportedNot reportedNot reported
LDK378 500 mg15386.5Not reportedNot reportedNot reported
LDK378 600 mg21259.7Not reportedNot reportedNot reported
LDK378 700 mg206145.6Not reportedNot reportedNot reported
LDK378 750 mg186126.9Not reportedNot reportedNot reported
C1D8 dose escalation phase

Analysis denominator · Participants

GroupSource count
LDK378 50 mg2
LDK378 100 mg2
LDK378 200 mg3
LDK378 300 mg3
LDK378 400 mg13
LDK378 500 mg9
LDK378 600 mg9
LDK378 700 mg5
LDK378 750 mg8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg25.137.5Not reportedNot reportedNot reported
LDK378 100 mg76.720.9Not reportedNot reportedNot reported
LDK378 200 mg21218.0Not reportedNot reportedNot reported
LDK378 300 mg381167.5Not reportedNot reportedNot reported
LDK378 400 mg41969.7Not reportedNot reportedNot reported
LDK378 500 mg64140.0Not reportedNot reportedNot reported
LDK378 600 mg68868.3Not reportedNot reportedNot reported
LDK378 700 mg114037.7Not reportedNot reportedNot reported
LDK378 750 mg67476.2Not 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 mg208
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 750 mg203100.9Not reportedNot reportedNot reported
C2D1 dose escalation & dose expansion phases

Analysis denominator · Participants

GroupSource count
LDK378 50 mg2
LDK378 100 mg1
LDK378 200 mg3
LDK378 300 mg0
LDK378 400 mg0
LDK378 500 mg0
LDK378 600 mg0
LDK378 700 mg0
LDK378 750 mg133
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg21.99.4Not reportedNot reportedNot reported
LDK378 100 mg53.5NANot reportedNot reportedN/A = not estimable
LDK378 200 mg229120.7Not reportedNot reportedNot reported
LDK378 750 mg101044.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N/A = not estimable
        group Id
        OG000
        spread
        NA
        value
        13.1
      2. group Id
        OG001
        spread
        10.1
        value
        29.3
      3. group Id
        OG002
        spread
        88.5
        value
        40.2
      4. group Id
        OG003
        spread
        41.5
        value
        198
      5. group Id
        OG004
        spread
        80.9
        value
        120
      6. group Id
        OG005
        spread
        86.5
        value
        153
      7. group Id
        OG006
        spread
        59.7
        value
        212
      8. group Id
        OG007
        spread
        145.6
        value
        206
      9. group Id
        OG008
        spread
        126.9
        value
        186
    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
        37.5
        value
        25.1
      2. group Id
        OG001
        spread
        20.9
        value
        76.7
      3. group Id
        OG002
        spread
        18.0
        value
        212
      4. group Id
        OG003
        spread
        167.5
        value
        381
      5. group Id
        OG004
        spread
        69.7
        value
        419
      6. group Id
        OG005
        spread
        40.0
        value
        641
      7. group Id
        OG006
        spread
        68.3
        value
        688
      8. group Id
        OG007
        spread
        37.7
        value
        1140
      9. group Id
        OG008
        spread
        76.2
        value
        674
    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
        13
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        9
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        8
      units
      Participants
    title
    C1D8 dose escalation phase
  3. categories
    1. measurements
      1. group Id
        OG008
        spread
        100.9
        value
        203
    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
        208
      units
      Participants
    title
    C1D1 dose escalation phase for 750mg
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.4
        value
        21.9
      2. comment
        N/A = not estimable
        group Id
        OG001
        spread
        NA
        value
        53.5
      3. group Id
        OG002
        spread
        120.7
        value
        229
      4. group Id
        OG008
        spread
        44.8
        value
        1010
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      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
        133
      units
      Participants
    title
    C2D1 dose escalation & dose 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
Cmax is the maximum observed concentration. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Cmax.
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 ion phase, Cycle 2 Day 1 of dose escalation & expansion phases
title
Primary Pharmacokinetics (PK) Parameter: Cmax
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice