Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00425555 · OUTCOME

Last Observed Plasma Concentration (Clast) of Panobinostat

Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma · Source last updated 2021-08-20

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8

What was measured

Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.

Analysis population: The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Groups in this outcome

All Participants

Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.

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

Analysis denominator · Participants

GroupSource count
All Participants139

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
All Participants109
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants0.6320.9737Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
All Participants60
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants1.5240.9076Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.9737
        value
        0.632
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.9076
        value
        1.524
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    Day 8
denoms
  1. counts
    1. group Id
      OG000
      value
      139
    units
    Participants
description
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
    id
    OG000
    title
    All Participants
param Type
MEAN
population Description
The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
reporting Status
POSTED
time Frame
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
title
Last Observed Plasma Concentration (Clast) of Panobinostat
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice