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NCT00531284 · OUTCOME

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for 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
h*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.

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 Bolus23
ST: CFZ 20 mg/m²18
ST: CFZ 36 mg/m²6
ST: CFZ 45 mg/m²6
MM: CFZ 20 mg/m²28

Reported measurements

Source class 1
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ST: CFZ 20 mg/m² Bolus223104Not reportedNot reportedNot reported
ST: CFZ 20 mg/m²32452.8Not reportedNot reportedNot reported
ST: CFZ 36 mg/m²42670.1Not reportedNot reportedNot reported
ST: CFZ 45 mg/m²538150.1Not reportedNot reportedNot reported
MM: CFZ 20 mg/m²27355.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        104
        value
        223
      2. group Id
        OG001
        spread
        52.8
        value
        324
      3. group Id
        OG002
        spread
        70.1
        value
        426
      4. group Id
        OG003
        spread
        150.1
        value
        538
      5. group Id
        OG004
        spread
        55.3
        value
        273
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      28
    units
    Participants
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
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib
type
SECONDARY
unit Of Measure
h*ng/mL

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

Preserved source evidence · Not medical advice