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NCT00949325 · OUTCOME

Part 1: Incidence of Dose Limiting Toxicities

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
End of second 28-day cycle

What was measured

Dose limiting toxicities in each dose cohort.

Groups in this outcome

Number of Subjects Who Experienced Dose-Limiting Toxicities

Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years. temsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity.

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

Analysis denominator · Participants

GroupSource count
Number of Subjects Who Experienced Dose-Limiting Toxicities24

Reported measurements

Temsirolimus 15 mg/m^2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Number of Subjects Who Experienced Dose-Limiting Toxicities1Not reportedNot reportedNot reportedNot reported
Temsirolimus 20 mg/m^2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Number of Subjects Who Experienced Dose-Limiting Toxicities4Not reportedNot reportedNot reportedNot reported
Temsirolimus 27 mg/m^2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Number of Subjects Who Experienced Dose-Limiting Toxicities3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Temsirolimus 15 mg/m^2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Temsirolimus 20 mg/m^2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Temsirolimus 27 mg/m^2
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Dose limiting toxicities in each dose cohort.
groups
  1. description
    Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years. temsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity.
    id
    OG000
    title
    Number of Subjects Who Experienced Dose-Limiting Toxicities
param Type
NUMBER
reporting Status
POSTED
time Frame
End of second 28-day cycle
title
Part 1: Incidence of Dose Limiting Toxicities
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice