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NCT00949325 · OUTCOME

Drug Clearance

Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma · Source last updated 2019-03-11

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

Measure
MEAN
Unit
L/hr/m2
Interval / dispersion
Standard Deviation
Time frame
Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.

What was measured

Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS.

Groups in this outcome

Temsirolimus- Parent Drug

Clearance was calculated using a single compartment model.

Sirolimus- Active Metabolite

Not reported

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

Analysis denominator · Participants

GroupSource count
Temsirolimus- Parent Drug7
Sirolimus- Active Metabolite7

Reported measurements

Source class 1
Values in L/hr/m2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Temsirolimus- Parent Drug17.87.1Not reportedNot reportedNot reported
Sirolimus- Active MetaboliteNANANot reportedNot reportedValues are not available. Drug clearance was not assessed in the Sirolimus-Active Metabolite arm.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.1
        value
        17.8
      2. comment
        Values are not available. Drug clearance was not assessed in the Sirolimus-Active Metabolite arm.
        group Id
        OG001
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS.
dispersion Type
Standard Deviation
groups
  1. description
    Clearance was calculated using a single compartment model.
    id
    OG000
    title
    Temsirolimus- Parent Drug
  2. id
    OG001
    title
    Sirolimus- Active Metabolite
param Type
MEAN
reporting Status
POSTED
time Frame
Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.
title
Drug Clearance
type
SECONDARY
unit Of Measure
L/hr/m2

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

Preserved source evidence · Not medical advice