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NCT00949325 · OUTCOME

Area Under the Curve (AUC)

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
ng*hr/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

AUC was calculated using a single compartment model.

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 analysis was per protocol. The number (N) evaluable samples is less than the number of collected samples due to inadvertent processing mishaps.

Groups in this outcome

Temsirolimus- Parent Drug

Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. AUC was calculated using a single compartment model.

Sirolimus- Active Metabolite

Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. AUC was calculated using a single non- compartment 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 ng*hr/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Temsirolimus- Parent Drug1210340Not reportedNot reportedNot reported
Sirolimus- Active Metabolite74994591.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        340
        value
        1210
      2. group Id
        OG001
        spread
        4591.1
        value
        7499
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
AUC was calculated using a single compartment model.
dispersion Type
Standard Deviation
groups
  1. description
    Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. AUC was calculated using a single compartment model.
    id
    OG000
    title
    Temsirolimus- Parent Drug
  2. description
    Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. AUC was calculated using a single non- compartment 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 analysis was per protocol. The number (N) evaluable samples is less than the number of collected samples 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
Area Under the Curve (AUC)
type
SECONDARY
unit Of Measure
ng*hr/ml

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

Preserved source evidence · Not medical advice