Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02703272 · OUTCOME

Part 1: Apparent (Oral) Volume of Distribution (Vd/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
liter(s)
Interval / dispersion
Full Range
Time frame
Up to Cycle 3 (each cycle of 21 or 28 days)

What was measured

Vd/F is defined as apparent (oral) volume of distribution 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 liter(s) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^211.1Not reported8.2613.9Not reported
Part 1: Ibrutinib: 329 mg/m^25.18Not reported5.185.18Not reported
Part 1: Ibrutinib: 440 mg/m^27.63Not reported5.3411.1Not 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 liter(s) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^218Not reported10.829.9Not reported
Part 1: Ibrutinib: 329 mg/m^27.55Not reported2.8915.6Not reported
Part 1: Ibrutinib: 440 mg/m^219Not reported6.0955.9Not 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 liter(s) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Ibrutinib: 240 mg/m^23.63Not reported2.324.77Not reported
Part 1: Ibrutinib: 329 mg/m^211.3Not reported6.3418.5Not 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
        8.26
        upper Limit
        13.9
        value
        11.1
      2. group Id
        OG001
        lower Limit
        5.18
        upper Limit
        5.18
        value
        5.18
      3. group Id
        OG002
        lower Limit
        5.34
        upper Limit
        11.1
        value
        7.63
    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
        10.8
        upper Limit
        29.9
        value
        18
      2. group Id
        OG001
        lower Limit
        2.89
        upper Limit
        15.6
        value
        7.55
      3. group Id
        OG002
        lower Limit
        6.09
        upper Limit
        55.9
        value
        19
    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
        2.32
        upper Limit
        4.77
        value
        3.63
      2. group Id
        OG001
        lower Limit
        6.34
        upper Limit
        18.5
        value
        11.3
    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
Vd/F is defined as apparent (oral) volume of distribution 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: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib
type
PRIMARY
unit Of Measure
liter(s)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice