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NCT01308580 · OUTCOME

Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer · Source last updated 2017-04-17

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

Measure
MEAN
Unit
litre
Interval / dispersion
Standard Deviation
Time frame
Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI

What was measured

Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.

Analysis population: Analysis was performed on PK population. Number of participants analyzed= participants with PK assessment at specified time-points.

Groups in this outcome

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Cabazitaxel 25 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 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
Cabazitaxel 20 mg/m^2133
Cabazitaxel 25 mg/m^2166

Reported measurements

Source class 1
Values in litre · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^27381.464488.72Not reportedNot reportedNot reported
Cabazitaxel 25 mg/m^27040.105133.12Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4488.72
        value
        7381.46
      2. group Id
        OG001
        spread
        5133.12
        value
        7040.10
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    2. group Id
      OG001
      value
      166
    units
    Participants
description
Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.
dispersion Type
Standard Deviation
groups
  1. description
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    OG000
    title
    Cabazitaxel 20 mg/m^2
  2. description
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    OG001
    title
    Cabazitaxel 25 mg/m^2
param Type
MEAN
population Description
Analysis was performed on PK population. Number of participants analyzed= participants with PK assessment at specified time-points.
reporting Status
POSTED
time Frame
Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI
title
Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel
type
SECONDARY
unit Of Measure
litre

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

Preserved source evidence · Not medical advice