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 27 Day 1

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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 27 Day 1

What was measured

Geometric mean of ratio (Cycle 27 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

Group	Source count
RP2D Cohort: Crizotinib 250 mg	2

Reported measurements

Testosterone

Values in Ratio · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: Crizotinib 250 mg	0.46	Not reported	0.00	61000.31	Not reported

Estradiol

Values in Ratio · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: Crizotinib 250 mg	0.97	Not reported	0.00	9022.66	Not reported

Prolactin

Values in Ratio · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: Crizotinib 250 mg	1.48	Not reported	0.11	20.69	Not reported

LH Serum

Values in Ratio · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: Crizotinib 250 mg	0.70	Not reported	0.11	4.50	Not reported

Follicle Stimulating Hormone

Values in Ratio · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: Crizotinib 250 mg	0.66	Not reported	0.06	7.53	Not reported

Free Testosterone

Values in Ratio · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: Crizotinib 250 mg	1.86	Not reported	0.02	147.95	Not reported

Sex Hormone Binding Globulin

Values in Ratio · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: Crizotinib 250 mg	0.24	Not reported	0.00	22059.61	Not reported

Dihydroepiandrosterone Sulfate

Values in Ratio · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: Crizotinib 250 mg	0.95	Not reported	0.24	3.78	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
61000.31
value
0.46
title
Testosterone
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
9022.66
value
0.97
title
Estradiol
categories
measurements
group Id
OG000
lower Limit
0.11
upper Limit
20.69
value
1.48
title
Prolactin
categories
measurements
group Id
OG000
lower Limit
0.11
upper Limit
4.50
value
0.70
title
LH Serum
categories
measurements
group Id
OG000
lower Limit
0.06
upper Limit
7.53
value
0.66
title
Follicle Stimulating Hormone
categories
measurements
group Id
OG000
lower Limit
0.02
upper Limit
147.95
value
1.86
title
Free Testosterone
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
22059.61
value
0.24
title
Sex Hormone Binding Globulin
categories
measurements
group Id
OG000
lower Limit
0.24
upper Limit
3.78
value
0.95
title
Dihydroepiandrosterone Sulfate

denoms

counts
group Id
OG000
value
2
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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 27 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 27 Day 1

type

PRIMARY

unit Of Measure

Ratio

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Preserved source evidence · Not medical advice