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NCT02290431 · OUTCOME

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax

Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-18

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose

What was measured

Cmax: The maximum (peak) observed plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ.

Analysis population: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.

Groups in this outcome

LBH589 + Bortezomib + Dexamethasone

Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.

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

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8

Reported measurements

PAN: Cycle 1 Day 1 (C1D1)

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone11.530.4Not reportedNot reportedNot reported
PAN: Cycle 1 Day 8 (C1D8)

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone18.241.5Not reportedNot reportedNot reported
BJB432: C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone1.0642.1Not reportedNot reportedNot reported
BJB432: C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone4.3884.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.4
        value
        11.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    PAN: Cycle 1 Day 1 (C1D1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.5
        value
        18.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    PAN: Cycle 1 Day 8 (C1D8)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.1
        value
        1.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    BJB432: C1D1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        84.2
        value
        4.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    BJB432: C1D8
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Cmax: The maximum (peak) observed plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
    id
    OG000
    title
    LBH589 + Bortezomib + Dexamethasone
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.
reporting Status
POSTED
time Frame
Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
title
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice