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NCT02293005 · OUTCOME

Disease Control Rate at 4 Months

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
4 months from treatment started

What was measured

Patients who are free of disease progression at 4 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 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.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Patients who are free of disease progression at 4 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 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.
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
COUNT_OF_PARTICIPANTS
population Description
1 patient did not complete one cycle of treatment and 25 patients were evaluable for efficacy.
reporting Status
POSTED
time Frame
4 months from treatment started
title
Disease Control Rate at 4 Months
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice