NCT01059643 · OUTCOME

Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307

A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck · Source last updated 2019-09-18

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

Measure: GEOMETRIC_MEAN
Unit: nanograms per milliliter (ng/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Day 3 of Cycle 1 (21-day cycle)

What was measured

Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).

Analysis population: All enrolled participants who received at least 1 dose of study drug with Cmax measure.

Groups in this outcome

5 mg/m² LY2523355

LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.

6 mg/m² LY253355

LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.

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
5 mg/m² LY2523355	65
6 mg/m² LY253355	31

Reported measurements

LY2523355

Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
5 mg/m² LY2523355	125	79	Not reported	Not reported	Not reported
6 mg/m² LY253355	124	67	Not reported	Not reported	Not reported

LSN2546307

Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
5 mg/m² LY2523355	5.0	51	Not reported	Not reported	Not reported
6 mg/m² LY253355	5.3	52	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
79
value
125
group Id
OG001
spread
67
value
124
title
LY2523355
categories
measurements
group Id
OG000
spread
51
value
5.0
group Id
OG001
spread
52
value
5.3
title
LSN2546307

denoms

counts
group Id
OG000
value
65
group Id
OG001
value
31
units
Participants

description

Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).

dispersion Type

Geometric Coefficient of Variation

groups

description
LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
id
OG000
title
5 mg/m² LY2523355
description
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
id
OG001
title
6 mg/m² LY253355

param Type

GEOMETRIC_MEAN

population Description

All enrolled participants who received at least 1 dose of study drug with Cmax measure.

reporting Status

POSTED

time Frame

Day 3 of Cycle 1 (21-day cycle)

title

Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307

type

SECONDARY

unit Of Measure

nanograms per milliliter (ng/mL)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice