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NCT02703272 · OUTCOME

Part 1: Area Under the Plasma Concentration-time Curve (AUC) 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
hours*nanogram per milliliter (h*ng/mL)
Interval / dispersion
Full Range
Time frame
Up to Cycle 3 (each cycle of 21 or 28 days)

What was measured

AUC is defined as area under the plasma concentration-time curve. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 milligrams per meter square \[mg/m\^2\], 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 hours*nanogram per milliliter (h*ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^2143Not reported116170Not reported
Part 1: Ibrutinib: 329 mg/m^2386Not reported386386Not reported
Part 1: Ibrutinib: 440 mg/m^2310Not reported230543Not 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 hours*nanogram per milliliter (h*ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^2145Not reported140233Not reported
Part 1: Ibrutinib: 329 mg/m^2349Not reported238562Not reported
Part 1: Ibrutinib: 440 mg/m^2324Not reported185538Not 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 hours*nanogram per milliliter (h*ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^21210Not reported9391450Not reported
Part 1: Ibrutinib: 329 mg/m^2661Not reported394778Not 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
        116
        upper Limit
        170
        value
        143
      2. group Id
        OG001
        lower Limit
        386
        upper Limit
        386
        value
        386
      3. group Id
        OG002
        lower Limit
        230
        upper Limit
        543
        value
        310
    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
        140
        upper Limit
        233
        value
        145
      2. group Id
        OG001
        lower Limit
        238
        upper Limit
        562
        value
        349
      3. group Id
        OG002
        lower Limit
        185
        upper Limit
        538
        value
        324
    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
        939
        upper Limit
        1450
        value
        1210
      2. group Id
        OG001
        lower Limit
        394
        upper Limit
        778
        value
        661
    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
AUC is defined as area under the plasma concentration-time curve. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 milligrams per meter square \[mg/m\^2\], 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: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib
type
PRIMARY
unit Of Measure
hours*nanogram per milliliter (h*ng/mL)

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Preserved source evidence · Not medical advice