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NCT01478581 · OUTCOME

Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for Cmax (M/P Cmax)

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-10

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

Measure
MEAN
Unit
Ratio
Interval / dispersion
Standard Deviation
Time frame
Procedure was performed up to 60 weeks.

What was measured

Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 Cmax/PCI-45227 molecular weight)/(ibrutinib Cmax/ibrutinib molecular weight) on Day 8.

Analysis population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.

Groups in this outcome

Cohort 1

PCI-32765 420 mg per day PCI-32765

Cohort 2

PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone

Cohort 3

PCI-32765 840 mg per day PCI-32765

Cohort 4

PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone

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

Analysis denominator · Participants

GroupSource count
Cohort 113
Cohort 216
Cohort 318
Cohort 443

Reported measurements

Source class 1
Values in Ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 10.9520.464Not reportedNot reportedNot reported
Cohort 21.470.632Not reportedNot reportedNot reported
Cohort 31.391.36Not reportedNot reportedNot reported
Cohort 41.390.746Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.464
        value
        0.952
      2. group Id
        OG001
        spread
        0.632
        value
        1.47
      3. group Id
        OG002
        spread
        1.36
        value
        1.39
      4. group Id
        OG003
        spread
        0.746
        value
        1.39
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      18
    4. group Id
      OG003
      value
      43
    units
    Participants
description
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 Cmax/PCI-45227 molecular weight)/(ibrutinib Cmax/ibrutinib molecular weight) on Day 8.
dispersion Type
Standard Deviation
groups
  1. description
    PCI-32765 420 mg per day PCI-32765
    id
    OG000
    title
    Cohort 1
  2. description
    PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    OG001
    title
    Cohort 2
  3. description
    PCI-32765 840 mg per day PCI-32765
    id
    OG002
    title
    Cohort 3
  4. description
    PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    OG003
    title
    Cohort 4
param Type
MEAN
population Description
All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
reporting Status
POSTED
time Frame
Procedure was performed up to 60 weeks.
title
Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for Cmax (M/P Cmax)
type
SECONDARY
unit Of Measure
Ratio

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Preserved source evidence · Not medical advice