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NCT02290431 · OUTCOME

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf

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
h.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

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: PAS: 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: AUClast C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone10614.7Not reportedNot reportedNot reported
PAN: AUClast C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone15631.7Not reportedNot reportedNot reported
BJB432: AUClast C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone37.838.2Not reportedNot reportedNot reported
BJB432: AUClast C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone16687.7Not reportedNot reportedNot reported
PAN: AUC0-24h C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone87.113.7Not reportedNot reportedNot reported
PAN: AUC0-24h C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone12530.1Not reportedNot reportedNot reported
BJB432: AUC0-24h C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone18.533.9Not reportedNot reportedNot reported
BJB432: AUC0-24h C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone83.876.1Not reportedNot reportedNot reported
PAN: AUC0-48h C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone10614.8Not reportedNot reportedNot reported
PAN: AUC0-48h C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone15631.7Not reportedNot reportedNot reported
BJB432: AUC0-48h C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone36.840.6Not reportedNot reportedNot reported
BJB432: AUC0-48h C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone6
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone16998.8Not reportedNot reportedNot reported
PAN: AUCinf C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone8
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone11615.5Not reportedNot reportedNot reported
PAN: AUCinf C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in h.ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone17532.7Not reportedNot reportedNot reported
BJB432: AUCinf C1D1

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone0
BJB432: AUCinf C1D8

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.7
        value
        106
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    PAN: AUClast C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.7
        value
        156
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    PAN: AUClast C1D8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.2
        value
        37.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    BJB432: AUClast C1D1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        87.7
        value
        166
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    BJB432: AUClast C1D8
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.7
        value
        87.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    PAN: AUC0-24h C1D1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.1
        value
        125
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    PAN: AUC0-24h C1D8
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.9
        value
        18.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    BJB432: AUC0-24h C1D1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.1
        value
        83.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    BJB432: AUC0-24h C1D8
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.8
        value
        106
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    PAN: AUC0-48h C1D1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.7
        value
        156
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    PAN: AUC0-48h C1D8
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.6
        value
        36.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    BJB432: AUC0-48h C1D1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        98.8
        value
        169
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    BJB432: AUC0-48h C1D8
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
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
PAS: 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: AUClast, AUC0-24h, AUC0-48h, AUCinf
type
SECONDARY
unit Of Measure
h.ng/mL

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Preserved source evidence · Not medical advice