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NCT00949325 · OUTCOME

Maximum Observed Plasma Concentration (Cmax)

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
mg/mL
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

Analysis population: Seven subjects had complete series of blood samples available for evaluation for both Temsirolimus, the parent drug and Sirolimus, the active metabolite. The number (N) evaluable participants is less than the number of participants from whom samples were collected due to inadvertent processing mishaps.

Groups in this outcome

Temsirolimus- Parent Drug

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

Sirolimus- Active Metabolite

Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. Cmax of Sirolimus was calculated using a non-compartmental model.

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 mg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Temsirolimus- Parent Drug346.2250Not reportedNot reportedNot reported
Sirolimus- Active Metabolite69.623.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        250
        value
        346.2
      2. group Id
        OG001
        spread
        23.2
        value
        69.6
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
    Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS
    id
    OG000
    title
    Temsirolimus- Parent Drug
  2. description
    Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. Cmax of Sirolimus was calculated using a non-compartmental model.
    id
    OG001
    title
    Sirolimus- Active Metabolite
param Type
MEAN
population Description
Seven subjects had complete series of blood samples available for evaluation for both Temsirolimus, the parent drug and Sirolimus, the active metabolite. The number (N) evaluable participants is less than the number of participants from whom samples were collected due to inadvertent processing mishaps.
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
Maximum Observed Plasma Concentration (Cmax)
type
SECONDARY
unit Of Measure
mg/mL

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

Preserved source evidence · Not medical advice