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NCT02293005 · OUTCOME

Progression Free Survival (PFS)

Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma · Source last updated 2022-10-04

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From treatment start to death/progression or last follow-up, whichever come first assessed up to 25 months.

What was measured

PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.1), 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 or RECIST 1.1 if mRECIST cannot be used.

Analysis population: 1 patient did not complete one cycle of treatment and 25 patients were evaluable for efficacy.

Groups in this outcome

Alisertib

Alisertib was administered PO at 50 mg BID for 7 days in each treatment cycle, followed by a 14-day, treatment-free period, for a 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
Alisertib25

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alisertib2.8Not reported1.34.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.3
        upper Limit
        4.0
        value
        2.8
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.1), 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 or RECIST 1.1 if mRECIST cannot be used.
dispersion Type
95% Confidence Interval
groups
  1. description
    Alisertib was administered PO at 50 mg BID for 7 days in each treatment cycle, followed by a 14-day, treatment-free period, for a 21-day cycle.
    id
    OG000
    title
    Alisertib
param Type
MEDIAN
population Description
1 patient did not complete one cycle of treatment and 25 patients were evaluable for efficacy.
reporting Status
POSTED
time Frame
From treatment start to death/progression or last follow-up, whichever come first assessed up to 25 months.
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice