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NCT01283516 · OUTCOME

Primary Pharmacokinetics (PK) Parameter: Tmax

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
MEDIAN
Unit
hour
Interval / dispersion
Full Range
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

Tmax is the time to reach Cmax. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. 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 Tmax.

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 hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LDK378 50 mg5.95Not reported5.955.95Not reported
LDK378 100 mg15.0Not reported6.0024.0Not reported
LDK378 200 mg5.08Not reported4.176.00Not reported
LDK378 300 mg4.00Not reported4.005.95Not reported
LDK378 400 mg4.99Not reported2.976.73Not reported
LDK378 500 mg3.98Not reported3.0023.5Not reported
LDK378 600 mg6.00Not reported3.0024.1Not reported
LDK378 700 mg6.00Not reported4.0025.0Not reported
LDK378 750 mg6.02Not reported3.9523.8Not 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 hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LDK378 50 mg2.46Not reported2.002.92Not reported
LDK378 100 mg3.49Not reported3.003.98Not reported
LDK378 200 mg3.00Not reported2.987.95Not reported
LDK378 300 mg4.00Not reported3.007.18Not reported
LDK378 400 mg6.08Not reported2.9824.0Not reported
LDK378 500 mg3.95Not reported1.936.00Not reported
LDK378 600 mg4.00Not reported0.0023.6Not reported
LDK378 700 mg5.97Not reported2.0024.0Not reported
LDK378 750 mg5.03Not reported3.007.95Not 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 hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LDK378 750 mg6.00Not reported1.1324.0Not 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 hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LDK378 50 mg5.00Not reported4.006.00Not reported
LDK378 100 mg2.08Not reported2.082.08Not reported
LDK378 200 mg8.00Not reported4.0023.9Not reported
LDK378 750 mg6.00Not reported0.0022.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.95
        upper Limit
        5.95
        value
        5.95
      2. group Id
        OG001
        lower Limit
        6.00
        upper Limit
        24.0
        value
        15.0
      3. group Id
        OG002
        lower Limit
        4.17
        upper Limit
        6.00
        value
        5.08
      4. group Id
        OG003
        lower Limit
        4.00
        upper Limit
        5.95
        value
        4.00
      5. group Id
        OG004
        lower Limit
        2.97
        upper Limit
        6.73
        value
        4.99
      6. group Id
        OG005
        lower Limit
        3.00
        upper Limit
        23.5
        value
        3.98
      7. group Id
        OG006
        lower Limit
        3.00
        upper Limit
        24.1
        value
        6.00
      8. group Id
        OG007
        lower Limit
        4.00
        upper Limit
        25.0
        value
        6.00
      9. group Id
        OG008
        lower Limit
        3.95
        upper Limit
        23.8
        value
        6.02
    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
        lower Limit
        2.00
        upper Limit
        2.92
        value
        2.46
      2. group Id
        OG001
        lower Limit
        3.00
        upper Limit
        3.98
        value
        3.49
      3. group Id
        OG002
        lower Limit
        2.98
        upper Limit
        7.95
        value
        3.00
      4. group Id
        OG003
        lower Limit
        3.00
        upper Limit
        7.18
        value
        4.00
      5. group Id
        OG004
        lower Limit
        2.98
        upper Limit
        24.0
        value
        6.08
      6. group Id
        OG005
        lower Limit
        1.93
        upper Limit
        6.00
        value
        3.95
      7. group Id
        OG006
        lower Limit
        0.00
        upper Limit
        23.6
        value
        4.00
      8. group Id
        OG007
        lower Limit
        2.00
        upper Limit
        24.0
        value
        5.97
      9. group Id
        OG008
        lower Limit
        3.00
        upper Limit
        7.95
        value
        5.03
    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
        lower Limit
        1.13
        upper Limit
        24.0
        value
        6.00
    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
        lower Limit
        4.00
        upper Limit
        6.00
        value
        5.00
      2. group Id
        OG001
        lower Limit
        2.08
        upper Limit
        2.08
        value
        2.08
      3. group Id
        OG002
        lower Limit
        4.00
        upper Limit
        23.9
        value
        8.00
      4. group Id
        OG008
        lower Limit
        0.00
        upper Limit
        22.6
        value
        6.00
    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
Tmax is the time to reach Cmax. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. 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 Tmax.
dispersion Type
Full Range
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
MEDIAN
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: Tmax
type
SECONDARY
unit Of Measure
hour

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

Preserved source evidence · Not medical advice