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NCT02703272 · OUTCOME

Part 1: Apparent (Oral) Plasma Clearance (CL/F) 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
milliliter per hour (mL/h)
Interval / dispersion
Full Range
Time frame
Up to Cycle 3 (each cycle of 21 or 28 days)

What was measured

CL/F is defined as apparent plasma clearance of ibrutinib. As per planned analyses, 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 milliliter per hour (mL/h) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^21220Not reported10001430Not reported
Part 1: Ibrutinib: 329 mg/m^2508Not reported508508Not reported
Part 1: Ibrutinib: 440 mg/m^21200Not reported8381550Not 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 milliliter per hour (mL/h) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^21450Not reported10801500Not reported
Part 1: Ibrutinib: 329 mg/m^2805Not reported6641100Not reported
Part 1: Ibrutinib: 440 mg/m^21300Not reported9102460Not 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 milliliter per hour (mL/h) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^2348Not reported340433Not reported
Part 1: Ibrutinib: 329 mg/m^2729Not reported5681330Not 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
        1000
        upper Limit
        1430
        value
        1220
      2. group Id
        OG001
        lower Limit
        508
        upper Limit
        508
        value
        508
      3. group Id
        OG002
        lower Limit
        838
        upper Limit
        1550
        value
        1200
    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
        1080
        upper Limit
        1500
        value
        1450
      2. group Id
        OG001
        lower Limit
        664
        upper Limit
        1100
        value
        805
      3. group Id
        OG002
        lower Limit
        910
        upper Limit
        2460
        value
        1300
    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
        340
        upper Limit
        433
        value
        348
      2. group Id
        OG001
        lower Limit
        568
        upper Limit
        1330
        value
        729
    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
CL/F is defined as apparent plasma clearance of ibrutinib. As per planned analyses, 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: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib
type
PRIMARY
unit Of Measure
milliliter per hour (mL/h)

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Preserved source evidence · Not medical advice