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NCT00585195 · OUTCOME

Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 12 Day 1

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer · Source last updated 2023-02-08

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

Measure
GEOMETRIC_MEAN
Unit
Ratio
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Cycle 12 Day 1

What was measured

Geometric mean of ratio (Cycle 12 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.

Analysis population: Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and 'number analyzed' =participants with available data for each specified category.

Groups in this outcome

RP2D Cohort: Crizotinib 250 mg

Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.

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

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg6

Reported measurements

Testosterone

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg6
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.38Not reported0.141.04Not reported
Estradiol

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg5
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.66Not reported0.321.37Not reported
Prolactin

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg6
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg1.06Not reported0.721.57Not reported
LH Serum

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg6
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.88Not reported0.591.32Not reported
Follicle Stimulating Hormone

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg6
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg1.02Not reported0.631.65Not reported
Free Testosterone

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg6
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg1.39Not reported0.682.86Not reported
Sex Hormone Binding Globulin

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg5
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.23Not reported0.110.46Not reported
Dihydroepiandrosterone Sulfate

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg5
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.75Not reported0.421.34Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.14
        upper Limit
        1.04
        value
        0.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Testosterone
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.32
        upper Limit
        1.37
        value
        0.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Estradiol
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        1.57
        value
        1.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Prolactin
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.59
        upper Limit
        1.32
        value
        0.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    LH Serum
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.63
        upper Limit
        1.65
        value
        1.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Follicle Stimulating Hormone
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.68
        upper Limit
        2.86
        value
        1.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Free Testosterone
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.11
        upper Limit
        0.46
        value
        0.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Sex Hormone Binding Globulin
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.42
        upper Limit
        1.34
        value
        0.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Dihydroepiandrosterone Sulfate
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Geometric mean of ratio (Cycle 12 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
    id
    OG000
    title
    RP2D Cohort: Crizotinib 250 mg
param Type
GEOMETRIC_MEAN
population Description
Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and 'number analyzed' =participants with available data for each specified category.
reporting Status
POSTED
time Frame
Baseline, Cycle 12 Day 1
title
Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 12 Day 1
type
PRIMARY
unit Of Measure
Ratio

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Preserved source evidence · Not medical advice