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NCT00531284 · OUTCOME

Time to Maximum Observed Plasma Concentration (Tmax) 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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
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.

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 hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
ST: CFZ 20 mg/m² Bolus0.0500Not reported00.167Not reported
ST: CFZ 20 mg/m²0.500Not reported0.08330.7500Not reported
ST: CFZ 36 mg/m²0.258Not reported0.08330.500Not reported
ST: CFZ 45 mg/m²0.275Not reported0.1000.550Not reported
MM: CFZ 20 mg/m²0.250Not reported0.08330.750Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.167
        value
        0.0500
      2. group Id
        OG001
        lower Limit
        0.0833
        upper Limit
        0.7500
        value
        0.500
      3. group Id
        OG002
        lower Limit
        0.0833
        upper Limit
        0.500
        value
        0.258
      4. group Id
        OG003
        lower Limit
        0.100
        upper Limit
        0.550
        value
        0.275
      5. group Id
        OG004
        lower Limit
        0.0833
        upper Limit
        0.750
        value
        0.250
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
dispersion Type
Full Range
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
MEDIAN
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
Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice