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NCT00858234 · OUTCOME

Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Vorinostat Administered With Bortezomib on Days 1 and 11

Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098) · Source last updated 2021-04-09

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

Measure
LEAST_SQUARES_MEAN
Unit
µM*hr
Interval / dispersion
95% Confidence Interval
Time frame
Predose and 0.8, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 1 and 11

What was measured

The AUC0-24hr of vorinostat in plasma on Days 1 and 11 is reported in participants who also received bortezomib.

Analysis population: Participants with data available are included.

Groups in this outcome

Vorinostat + Bortezomib

Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).

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

Analysis denominator · Participants

GroupSource count
Vorinostat + Bortezomib9

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Vorinostat + Bortezomib9
Values in µM*hr · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vorinostat + Bortezomib5.41Not reported4.336.77Not reported
Day 11

Analysis denominator · Participants

GroupSource count
Vorinostat + Bortezomib7
Values in µM*hr · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vorinostat + Bortezomib5.84Not reported4.487.61Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.45
    estimate Comment
    Back-transformed least squares mean difference and 90% confidence interval from mixed effects model performed on natural log-transformed values.
    group Ids
    1. OG000
    non Inferiority Comment
    Accumulation Ratio (Day 11 AUC0-24hr/Day 1 AUC0-24hr)
    non Inferiority Type
    OTHER
    param Type
    Accumulation ratio
    param Value
    1.08
Complete source fields
analyses
  1. ci Lower Limit
    0.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.45
    estimate Comment
    Back-transformed least squares mean difference and 90% confidence interval from mixed effects model performed on natural log-transformed values.
    group Ids
    1. OG000
    non Inferiority Comment
    Accumulation Ratio (Day 11 AUC0-24hr/Day 1 AUC0-24hr)
    non Inferiority Type
    OTHER
    param Type
    Accumulation ratio
    param Value
    1.08
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.33
        upper Limit
        6.77
        value
        5.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.48
        upper Limit
        7.61
        value
        5.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Day 11
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
The AUC0-24hr of vorinostat in plasma on Days 1 and 11 is reported in participants who also received bortezomib.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).
    id
    OG000
    title
    Vorinostat + Bortezomib
param Type
LEAST_SQUARES_MEAN
population Description
Participants with data available are included.
reporting Status
POSTED
time Frame
Predose and 0.8, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 1 and 11
title
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Vorinostat Administered With Bortezomib on Days 1 and 11
type
OTHER_PRE_SPECIFIED
unit Of Measure
µM*hr

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Preserved source evidence · Not medical advice