Skip to content
← Full study record

NCT01653028 · OUTCOME

Progression Free Survival (PFS)

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma · Source last updated 2017-11-30

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

Measure
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
The time between registration to disease progression or death, assessed up to 18 months

What was measured

The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).

Groups in this outcome

Cohort 1

Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohort 2

Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohort 3

Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohort 4

Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohort 5

Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable 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
Cohort 112
Cohort 210
Cohort 311
Cohort 410
Cohort 529

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 113Not reported6.2937.1Not reported
Cohort 211.7Not reported1.7121.9Not reported
Cohort 311.7Not reported520.6Not reported
Cohort 413.2Not reported3.5745Not reported
Cohort 56.57Not reported5.8618.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.29
        upper Limit
        37.1
        value
        13
      2. group Id
        OG001
        lower Limit
        1.71
        upper Limit
        21.9
        value
        11.7
      3. group Id
        OG002
        lower Limit
        5
        upper Limit
        20.6
        value
        11.7
      4. group Id
        OG003
        lower Limit
        3.57
        upper Limit
        45
        value
        13.2
      5. group Id
        OG004
        lower Limit
        5.86
        upper Limit
        18.1
        value
        6.57
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      11
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      29
    units
    Participants
description
The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).
dispersion Type
95% Confidence Interval
groups
  1. description
    Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Cohort 1
  2. description
    Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Cohort 2
  3. description
    Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    Cohort 3
  4. description
    Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG003
    title
    Cohort 4
  5. description
    Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG004
    title
    Cohort 5
param Type
MEDIAN
reporting Status
POSTED
time Frame
The time between registration to disease progression or death, assessed up to 18 months
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice