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NCT01283516 · OUTCOME

Secondary Pharmacokinetics (PK) Parameter: Racc

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
unitless
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases

What was measured

Racc is the accumulation ratio calculated using AUCtau values obtained from a dosing interval at steady-state divided by AUCtau at day 1 or PK run-in phase. AUCtau is the AUC calculated to the end of the dosing interval, tau. 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. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Racc.

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

C1D8: dose escalation phase

Analysis denominator · Participants

GroupSource count
LDK378 50 mg1
LDK378 100 mg2
LDK378 200 mg2
LDK378 300 mg2
LDK378 400 mg7
LDK378 500 mg7
LDK378 600 mg6
LDK378 700 mg2
LDK378 750 mg8
Values in unitless · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg2.56NANot reportedNot reportedN/A = not estimable
LDK378 100 mg3.2553.5Not reportedNot reportedNot reported
LDK378 200 mg6.6217.6Not reportedNot reportedNot reported
LDK378 300 mg1.83215.9Not reportedNot reportedNot reported
LDK378 400 mg3.80124.7Not reportedNot reportedNot reported
LDK378 500 mg6.0871.5Not reportedNot reportedNot reported
LDK378 600 mg3.5551.7Not reportedNot reportedNot reported
LDK378 700 mg6.8489.4Not reportedNot reportedNot reported
LDK378 750 mg4.6872.1Not reportedNot reportedNot reported
C2D1: dose escalation & dose 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 mg9
Values in unitless · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDK378 50 mg1.67NANot reportedNot reportedN/A = not estimable
LDK378 100 mg1.77NANot reportedNot reportedN/A = not estimable
LDK378 750 mg6.2058.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N/A = not estimable
        group Id
        OG000
        spread
        NA
        value
        2.56
      2. group Id
        OG001
        spread
        53.5
        value
        3.25
      3. group Id
        OG002
        spread
        17.6
        value
        6.62
      4. group Id
        OG003
        spread
        215.9
        value
        1.83
      5. group Id
        OG004
        spread
        124.7
        value
        3.80
      6. group Id
        OG005
        spread
        71.5
        value
        6.08
      7. group Id
        OG006
        spread
        51.7
        value
        3.55
      8. group Id
        OG007
        spread
        89.4
        value
        6.84
      9. group Id
        OG008
        spread
        72.1
        value
        4.68
    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
        2
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        7
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        8
      units
      Participants
    title
    C1D8: dose escalation phase
  2. categories
    1. measurements
      1. comment
        N/A = not estimable
        group Id
        OG000
        spread
        NA
        value
        1.67
      2. comment
        N/A = not estimable
        group Id
        OG001
        spread
        NA
        value
        1.77
      3. group Id
        OG008
        spread
        58.5
        value
        6.20
    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
        9
      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
Racc is the accumulation ratio calculated using AUCtau values obtained from a dosing interval at steady-state divided by AUCtau at day 1 or PK run-in phase. AUCtau is the AUC calculated to the end of the dosing interval, tau. 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. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Racc.
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
Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
title
Secondary Pharmacokinetics (PK) Parameter: Racc
type
SECONDARY
unit Of Measure
unitless

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

Preserved source evidence · Not medical advice