Skip to content
Triangle logo TriangleGet started
← Full study record

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 1 Day 15

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 1 Day 15

What was measured

Geometric mean of ratio (Cycle1Day15/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.

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 mg28

Reported measurements

Testosterone

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg22
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.46Not reported0.340.62Not reported
Estradiol

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg19
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.53Not reported0.420.66Not reported
Prolactin

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg22
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg1.19Not reported0.911.55Not reported
Luteinizing Hormone (LH) Serum

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg22
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.58Not reported0.470.73Not reported
Follicle Stimulating Hormone

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg22
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.77Not reported0.660.91Not reported
Free Testosterone

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg22
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.96Not reported0.661.40Not reported
Sex Hormone Binding Globulin

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg28
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.36Not reported0.320.41Not reported
Dihydroepiandrosterone Sulfate

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg21
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.97Not reported0.851.11Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.34
        upper Limit
        0.62
        value
        0.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Testosterone
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.42
        upper Limit
        0.66
        value
        0.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    Estradiol
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.91
        upper Limit
        1.55
        value
        1.19
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Prolactin
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.47
        upper Limit
        0.73
        value
        0.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Luteinizing Hormone (LH) Serum
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.66
        upper Limit
        0.91
        value
        0.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Follicle Stimulating Hormone
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.66
        upper Limit
        1.40
        value
        0.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Free Testosterone
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.32
        upper Limit
        0.41
        value
        0.36
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Sex Hormone Binding Globulin
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.85
        upper Limit
        1.11
        value
        0.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      units
      Participants
    title
    Dihydroepiandrosterone Sulfate
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
description
Geometric mean of ratio (Cycle1Day15/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.
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 1 Day 15
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 1 Day 15
type
PRIMARY
unit Of Measure
Ratio

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice