NCT00932893 · OUTCOME

Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene · Source last updated 2017-01-02

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

Measure: MEAN
Unit: nanogram per milliliter (ng/mL)
Interval / dispersion: Standard Deviation
Time frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)

What was measured

Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.

Analysis population: The soluble biomarker-evaluable population includes patients from the SA population that received PF-02341066, who have an optional blood sample prior to dosing on Cycle 1 Day 1 and have at least 1 on-treatment soluble biomarker evaluation (Cycle 2 Day 1 and/or end of treatment).

Groups in this outcome

Overall Values

Overall assessment for complete response, partial response, stable disease, progressive disease and early death

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
Overall Values	172

Reported measurements

Baseline (N = 81)

Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Overall Values	1428.3	363.9	Not reported	Not reported	Not reported

Cycle 2 Day 1 6-hour post dose (N = 69)

Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Overall Values	1683.0	325.6	Not reported	Not reported	Not reported

End of treatment (N = 40)

Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Overall Values	1751.8	327.9	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
363.9
value
1428.3
title
Baseline (N = 81)
categories
measurements
group Id
OG000
spread
325.6
value
1683.0
title
Cycle 2 Day 1 6-hour post dose (N = 69)
categories
measurements
group Id
OG000
spread
327.9
value
1751.8
title
End of treatment (N = 40)

denoms

counts
group Id
OG000
value
172
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Overall assessment for complete response, partial response, stable disease, progressive disease and early death
id
OG000
title
Overall Values

param Type

MEAN

population Description

The soluble biomarker-evaluable population includes patients from the SA population that received PF-02341066, who have an optional blood sample prior to dosing on Cycle 1 Day 1 and have at least 1 on-treatment soluble biomarker evaluation (Cycle 2 Day 1 and/or end of treatment).

reporting Status

POSTED

time Frame

Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)

title

Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins

type

SECONDARY

unit Of Measure

nanogram per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice