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NCT00949325 · OUTCOME

Objective Response Rate

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 5 years

What was measured

Number of participants who completed at least 2 treatment cycles with evidence of response. Response is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression

Analysis population: Only participants who completed at least 2 treatment cycles (14/18 participants) were included to assess this outcome measure.

Groups in this outcome

Temsirolimus 20 mg/m^2 and 27 mg/m^2

Subjects who completed at least 2 cycles of treatment with temsirolimus dose of 20 mg/m\^2 or 27 mg/m\^2 were assessed for radiologic response.

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 20 mg/m^2 and 27 mg/m^214

Reported measurements

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Temsirolimus 20 mg/m^2 and 27 mg/m^20Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Temsirolimus 20 mg/m^2 and 27 mg/m^21Not reportedNot reportedNot reportedNot reported
SD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Temsirolimus 20 mg/m^2 and 27 mg/m^28Not reportedNot reportedNot reportedNot reported
PD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Temsirolimus 20 mg/m^2 and 27 mg/m^25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    SD
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    PD
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Number of participants who completed at least 2 treatment cycles with evidence of response. Response is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
groups
  1. description
    Subjects who completed at least 2 cycles of treatment with temsirolimus dose of 20 mg/m\^2 or 27 mg/m\^2 were assessed for radiologic response.
    id
    OG000
    title
    Temsirolimus 20 mg/m^2 and 27 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
Only participants who completed at least 2 treatment cycles (14/18 participants) were included to assess this outcome measure.
reporting Status
POSTED
time Frame
up to 5 years
title
Objective Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice