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NCT01466881 · OUTCOME

Aurora Kinase A Expression

Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma · Source last updated 2016-03-10

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

Measure
MEAN
Unit
proportion of positivity
Interval / dispersion
Standard Deviation
Time frame
Baseline

What was measured

To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237

Analysis population: Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.

Groups in this outcome

Non-responders

Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.

Responders

Eligible Patients who received protocol treatment and achieved complete or partial 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
Non-responders19
Responders3

Reported measurements

Source class 1
Values in proportion of positivity · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Non-responders0.1210.096Not reportedNot reportedNot reported
Responders0.0630.060Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Description
    The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2316
    statistical Comment
    Two-sided alpha level of 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2316
    statistical Comment
    Two-sided alpha level of 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.096
        value
        0.121
      2. group Id
        OG001
        spread
        0.060
        value
        0.063
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      3
    units
    Participants
description
To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237
dispersion Type
Standard Deviation
groups
  1. description
    Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.
    id
    OG000
    title
    Non-responders
  2. description
    Eligible Patients who received protocol treatment and achieved complete or partial response.
    id
    OG001
    title
    Responders
param Type
MEAN
population Description
Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.
reporting Status
POSTED
time Frame
Baseline
title
Aurora Kinase A Expression
type
OTHER_PRE_SPECIFIED
unit Of Measure
proportion of positivity

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

Preserved source evidence · Not medical advice