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NCT02703272 · OUTCOME

Part 1: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma · Source last updated 2022-12-02

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

Measure
MEDIAN
Unit
nanograms per milliliter (ng/mL)
Interval / dispersion
Full Range
Time frame
Up to Cycle 3 (each cycle of 21 or 28 days)

What was measured

Cmax is defined as maximum plasma concentration of ibrutinib. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 mg/m\^2, 329 mg/m\^2 and 440 mg/m\^2) and age group (1-5, 6-11, 12-17 and \>18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age.

Analysis population: PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, "n (number analyzed)" is defined as number of participants analyzed for specified category.

Groups in this outcome

Part 1: Ibrutinib: 240 mg/m^2

Participants received 240 milligrams per meter square (mg/m\^2) ibrutinib based on age group for 3 treatment cycles with each cycle of 21 or 28 days long in part 1.

Part 1: Ibrutinib: 329 mg/m^2

Participants received 329 mg/m\^2 ibrutinib based on age group for 3 treatment cycles with each cycle of 21 or 28 days long in part 1.

Part 1: Ibrutinib: 440 mg/m^2

Participants received 440 mg/m\^2 ibrutinib based on age group for 3 treatment cycles with each cycle of 21 or 28 days long in part 1.

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

Analysis denominator · Participants

GroupSource count
Part 1: Ibrutinib: 240 mg/m^23
Part 1: Ibrutinib: 329 mg/m^210
Part 1: Ibrutinib: 440 mg/m^27

Reported measurements

1-5 years

Analysis denominator · Participants

GroupSource count
Part 1: Ibrutinib: 240 mg/m^22
Part 1: Ibrutinib: 329 mg/m^21
Part 1: Ibrutinib: 440 mg/m^23
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^23.86Not reported3.753.98Not reported
Part 1: Ibrutinib: 329 mg/m^24.48Not reported4.484.48Not reported
Part 1: Ibrutinib: 440 mg/m^25.07Not reported4.55.14Not reported
6-11 years

Analysis denominator · Participants

GroupSource count
Part 1: Ibrutinib: 240 mg/m^23
Part 1: Ibrutinib: 329 mg/m^210
Part 1: Ibrutinib: 440 mg/m^27
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^23.46Not reported3.123.6Not reported
Part 1: Ibrutinib: 329 mg/m^23.64Not reported3.324.59Not reported
Part 1: Ibrutinib: 440 mg/m^23.88Not reported3.24.44Not reported
12-17 years

Analysis denominator · Participants

GroupSource count
Part 1: Ibrutinib: 240 mg/m^23
Part 1: Ibrutinib: 329 mg/m^28
Part 1: Ibrutinib: 440 mg/m^20
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^24.88Not reported4.765.4Not reported
Part 1: Ibrutinib: 329 mg/m^24.73Not reported4.075.07Not reported
18+ years

Analysis denominator · Participants

GroupSource count
Part 1: Ibrutinib: 240 mg/m^20
Part 1: Ibrutinib: 329 mg/m^20
Part 1: Ibrutinib: 440 mg/m^20
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.75
        upper Limit
        3.98
        value
        3.86
      2. group Id
        OG001
        lower Limit
        4.48
        upper Limit
        4.48
        value
        4.48
      3. group Id
        OG002
        lower Limit
        4.5
        upper Limit
        5.14
        value
        5.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    1-5 years
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.12
        upper Limit
        3.6
        value
        3.46
      2. group Id
        OG001
        lower Limit
        3.32
        upper Limit
        4.59
        value
        3.64
      3. group Id
        OG002
        lower Limit
        3.2
        upper Limit
        4.44
        value
        3.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    6-11 years
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.76
        upper Limit
        5.4
        value
        4.88
      2. group Id
        OG001
        lower Limit
        4.07
        upper Limit
        5.07
        value
        4.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    12-17 years
  4. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    18+ years
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      7
    units
    Participants
description
Cmax is defined as maximum plasma concentration of ibrutinib. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 mg/m\^2, 329 mg/m\^2 and 440 mg/m\^2) and age group (1-5, 6-11, 12-17 and \>18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age.
dispersion Type
Full Range
groups
  1. description
    Participants received 240 milligrams per meter square (mg/m\^2) ibrutinib based on age group for 3 treatment cycles with each cycle of 21 or 28 days long in part 1.
    id
    OG000
    title
    Part 1: Ibrutinib: 240 mg/m^2
  2. description
    Participants received 329 mg/m\^2 ibrutinib based on age group for 3 treatment cycles with each cycle of 21 or 28 days long in part 1.
    id
    OG001
    title
    Part 1: Ibrutinib: 329 mg/m^2
  3. description
    Participants received 440 mg/m\^2 ibrutinib based on age group for 3 treatment cycles with each cycle of 21 or 28 days long in part 1.
    id
    OG002
    title
    Part 1: Ibrutinib: 440 mg/m^2
param Type
MEDIAN
population Description
PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, "n (number analyzed)" is defined as number of participants analyzed for specified category.
reporting Status
POSTED
time Frame
Up to Cycle 3 (each cycle of 21 or 28 days)
title
Part 1: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
type
PRIMARY
unit Of Measure
nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice