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NCT04062448 · OUTCOME

Plasma Concentrations of Metabolite PCI-45227

A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM) · Source last updated 2025-05-25

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 1 of Week 4: Predose, 1 hour, 2 hours, 4 hours, and 6 hours postdose

What was measured

Plasma concentrations of metabolite PCI-45227 were reported.

Analysis population: The PK evaluable analysis set included all enrolled participants who had received at least 1 dose of ibrutinib and had at least 1 post-dose PK sample. Here, n (number analyzed) refers to number of participants evaluable for specified timepoints.

Groups in this outcome

Ibrutinib + Rituximab

Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.

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

Analysis denominator · Participants

GroupSource count
Ibrutinib + Rituximab15

Reported measurements

Week 4: Predose

Analysis denominator · Participants

GroupSource count
Ibrutinib + Rituximab15
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib + Rituximab13.714.8Not reportedNot reportedNot reported
Week 4: 1 hour postdose

Analysis denominator · Participants

GroupSource count
Ibrutinib + Rituximab15
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib + Rituximab39.942.3Not reportedNot reportedNot reported
Week 4: 2 hours postdose

Analysis denominator · Participants

GroupSource count
Ibrutinib + Rituximab15
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib + Rituximab63.962.3Not reportedNot reportedNot reported
Week 4: 4 hours postdose

Analysis denominator · Participants

GroupSource count
Ibrutinib + Rituximab15
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib + Rituximab79.651.5Not reportedNot reportedNot reported
Week 4: 6 hour postdose

Analysis denominator · Participants

GroupSource count
Ibrutinib + Rituximab14
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib + Rituximab65.643.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.8
        value
        13.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Week 4: Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.3
        value
        39.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Week 4: 1 hour postdose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.3
        value
        63.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Week 4: 2 hours postdose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.5
        value
        79.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Week 4: 4 hours postdose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.1
        value
        65.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Week 4: 6 hour postdose
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Plasma concentrations of metabolite PCI-45227 were reported.
dispersion Type
Standard Deviation
groups
  1. description
    Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.
    id
    OG000
    title
    Ibrutinib + Rituximab
param Type
MEAN
population Description
The PK evaluable analysis set included all enrolled participants who had received at least 1 dose of ibrutinib and had at least 1 post-dose PK sample. Here, n (number analyzed) refers to number of participants evaluable for specified timepoints.
reporting Status
POSTED
time Frame
Day 1 of Week 4: Predose, 1 hour, 2 hours, 4 hours, and 6 hours postdose
title
Plasma Concentrations of Metabolite PCI-45227
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice