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NCT01949532 · OUTCOME

Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-519/M16

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease · Source last updated 2017-05-02

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

Measure
GEOMETRIC_MEAN
Unit
ng*h/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.

Analysis population: PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.

Groups in this outcome

Normal Renal Function

Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.

End Stage Renal Disease

Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.

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

Analysis denominator · Participants

GroupSource count
Normal Renal Function13
End Stage Renal Disease9

Reported measurements

Cycle 1, Day 16 (n = 13, 9)
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Normal Renal Function84.452.4Not reportedNot reportedNot reported
End Stage Renal Disease89.642.8Not reportedNot reportedNot reported
Cycle 2, Day 1 (n = 10, 8)
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Normal Renal Function14851.7Not reportedNot reportedNot reported
End Stage Renal Disease139125.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.4
        value
        84.4
      2. group Id
        OG001
        spread
        42.8
        value
        89.6
    title
    Cycle 1, Day 16 (n = 13, 9)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.7
        value
        148
      2. group Id
        OG001
        spread
        125.1
        value
        139
    title
    Cycle 2, Day 1 (n = 10, 8)
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      9
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
    id
    OG000
    title
    Normal Renal Function
  2. description
    Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
    id
    OG001
    title
    End Stage Renal Disease
param Type
GEOMETRIC_MEAN
population Description
PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.
reporting Status
POSTED
time Frame
Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.
title
Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-519/M16
type
SECONDARY
unit Of Measure
ng*h/mL

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

Preserved source evidence · Not medical advice