Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00531284 · OUTCOME

Maximum Observed Plasma Concentration of Carfilzomib

Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma · Source last updated 2017-08-15

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
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.

What was measured

Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.

Analysis population: Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).

Groups in this outcome

ST: CFZ 20 mg/m² Bolus

Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.

ST: CFZ 20 mg/m²

Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.

ST: CFZ 36 mg/m²

Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.

ST: CFZ 45 mg/m²

Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.

MM: CFZ 20 mg/m²

Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.

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

Analysis denominator · Participants

GroupSource count
ST: CFZ 20 mg/m² Bolus30
ST: CFZ 20 mg/m²21
ST: CFZ 36 mg/m²6
ST: CFZ 45 mg/m²6
MM: CFZ 20 mg/m²30

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ST: CFZ 20 mg/m² Bolus2390104Not reportedNot reportedNot reported
ST: CFZ 20 mg/m²91458.2Not reportedNot reportedNot reported
ST: CFZ 36 mg/m²106150.7Not reportedNot reportedNot reported
ST: CFZ 45 mg/m²1193197.3Not reportedNot reportedNot reported
MM: CFZ 20 mg/m²72262.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        104
        value
        2390
      2. group Id
        OG001
        spread
        58.2
        value
        914
      3. group Id
        OG002
        spread
        50.7
        value
        1061
      4. group Id
        OG003
        spread
        197.3
        value
        1193
      5. group Id
        OG004
        spread
        62.1
        value
        722
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      30
    units
    Participants
description
Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
    id
    OG000
    title
    ST: CFZ 20 mg/m² Bolus
  2. description
    Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
    id
    OG001
    title
    ST: CFZ 20 mg/m²
  3. description
    Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
    id
    OG002
    title
    ST: CFZ 36 mg/m²
  4. description
    Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
    id
    OG003
    title
    ST: CFZ 45 mg/m²
  5. description
    Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
    id
    OG004
    title
    MM: CFZ 20 mg/m²
param Type
GEOMETRIC_MEAN
population Description
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
reporting Status
POSTED
time Frame
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
title
Maximum Observed Plasma Concentration of Carfilzomib
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice