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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 30 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 30 Day 1

What was measured

Geometric mean of ratio (Cycle 30 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 outcome measure.

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 mg1

Reported measurements

Testosterone
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.16Not reportedNot reportedNot reportedNot reported
Estradiol
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.38Not reportedNot reportedNot reportedNot reported
Prolactin
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg1.14Not reportedNot reportedNot reportedNot reported
LH Serum
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.85Not reportedNot reportedNot reportedNot reported
Follicle Stimulating Hormone
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.80Not reportedNot reportedNot reportedNot reported
Free Testosterone
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg1.25Not reportedNot reportedNot reportedNot reported
Sex Hormone Binding Globulin
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.09Not reportedNot reportedNot reportedNot reported
Dihydroepiandrosterone Sulfate
Values in Ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg0.71Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.16
    title
    Testosterone
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.38
    title
    Estradiol
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1.14
    title
    Prolactin
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.85
    title
    LH Serum
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.80
    title
    Follicle Stimulating Hormone
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1.25
    title
    Free Testosterone
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.09
    title
    Sex Hormone Binding Globulin
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0.71
    title
    Dihydroepiandrosterone Sulfate
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Geometric mean of ratio (Cycle 30 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 outcome measure.
reporting Status
POSTED
time Frame
Baseline, Cycle 30 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 30 Day 1
type
PRIMARY
unit Of Measure
Ratio

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Preserved source evidence · Not medical advice