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NCT01139775 · OUTCOME

Phase 1: Pharmacokinetic: Area Under the Plasma Concentration Versus Time Curve (AUC) (LY2603618)

A Study in Non Small Cell Lung Cancer · Source last updated 2018-05-18

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

Measure: GEOMETRIC_MEAN
Unit: ng*h/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose

What was measured

AUC from time zero to 24 hours (AUC\[0-24\]), AUC from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]), and AUC from time zero to infinity (AUC\[0-∞\]) values are reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.

Analysis population: Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.

Groups in this outcome

Phase 1: Pemetrexed + Cisplatin + LY2603618

Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.

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
Phase 1: Pemetrexed + Cisplatin + LY2603618	13

Reported measurements

130 mg, Cycle 1/Day 2, AUC(0-24)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	8700	30	Not reported	Not reported	Not reported

130 mg, Cycle 2/Day 2, AUC(0-24)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	9780	43	Not reported	Not reported	Not reported

130 mg, Cycle 1/Day 2, AUC(0-tlast)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	10200	26	Not reported	Not reported	Not reported

130 mg, Cycle 2/Day 2, AUC(0-tlast)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	11300	44	Not reported	Not reported	Not reported

130 mg, Cycle 1/Day 2, AUC(0-∞)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	10200	26	Not reported	Not reported	Not reported

130 mg, Cycle 2/Day 2, AUC(0-∞)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	11300	45	Not reported	Not reported	Not reported

185 mg, Cycle 1/Day 2, AUC(0-24)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	13800	119	Not reported	Not reported	Not reported

185 mg, Cycle 2/Day 2, AUC(0-24)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	12500	170	Not reported	Not reported	Not reported

185 mg, Cycle 1/Day 2, AUC(0-tlast)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	18300	192	Not reported	Not reported	Not reported

185 mg, Cycle 2/Day 2, AUC(0-tlast)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	14800	217	Not reported	Not reported	Not reported

185 mg, Cycle 1/Day 2, AUC(0-∞)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	18400	193	Not reported	Not reported	Not reported

185 mg, Cycle 2/Day 2, AUC(0-∞)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	15700	253	Not reported	Not reported	Not reported

240 mg, Cycle 1/Day 2, AUC(0-24)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	26200	19	Not reported	Not reported	Not reported

240 mg, Cycle 2/Day 2, AUC(0-24)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	22100	31	Not reported	Not reported	Not reported

240 mg, Cycle 1/Day 2, AUC(0-tlast)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	32200	21	Not reported	Not reported	Not reported

240 mg, Cycle 2/Day 2, AUC(0-tlast)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	27300	31	Not reported	Not reported	Not reported

240 mg, Cycle 1/Day 2, AUC(0-∞)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	32300	21	Not reported	Not reported	Not reported

240 mg, Cycle 2/Day 2, AUC(0-∞)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	3

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	27500	31	Not reported	Not reported	Not reported

275 mg, Cycle 1/Day 2, AUC(0-24)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	4

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	28900	24	Not reported	Not reported	Not reported

275 mg, Cycle 2/Day 2, AUC(0-24)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	4

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	23500	31	Not reported	Not reported	Not reported

275 mg, Cycle 1/Day 2, AUC(0-tlast)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	4

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	38100	36	Not reported	Not reported	Not reported

275 mg, Cycle 2/Day 2, AUC(0-tlast)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	4

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	30800	44	Not reported	Not reported	Not reported

275 mg, Cycle 1/Day 2, AUC(0-∞)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	4

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	38300	37	Not reported	Not reported	Not reported

275 mg, Cycle 2/Day 2, AUC(0-∞)

Analysis denominator · Participants

Group	Source count
Phase 1: Pemetrexed + Cisplatin + LY2603618	4

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Pemetrexed + Cisplatin + LY2603618	30900	44	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
30
value
8700
denoms
counts
group Id
OG000
value
3
units
Participants
title
130 mg, Cycle 1/Day 2, AUC(0-24)
categories
measurements
group Id
OG000
spread
43
value
9780
denoms
counts
group Id
OG000
value
3
units
Participants
title
130 mg, Cycle 2/Day 2, AUC(0-24)
categories
measurements
group Id
OG000
spread
26
value
10200
denoms
counts
group Id
OG000
value
3
units
Participants
title
130 mg, Cycle 1/Day 2, AUC(0-tlast)
categories
measurements
group Id
OG000
spread
44
value
11300
denoms
counts
group Id
OG000
value
3
units
Participants
title
130 mg, Cycle 2/Day 2, AUC(0-tlast)
categories
measurements
group Id
OG000
spread
26
value
10200
denoms
counts
group Id
OG000
value
3
units
Participants
title
130 mg, Cycle 1/Day 2, AUC(0-∞)
categories
measurements
group Id
OG000
spread
45
value
11300
denoms
counts
group Id
OG000
value
3
units
Participants
title
130 mg, Cycle 2/Day 2, AUC(0-∞)
categories
measurements
group Id
OG000
spread
119
value
13800
denoms
counts
group Id
OG000
value
3
units
Participants
title
185 mg, Cycle 1/Day 2, AUC(0-24)
categories
measurements
group Id
OG000
spread
170
value
12500
denoms
counts
group Id
OG000
value
3
units
Participants
title
185 mg, Cycle 2/Day 2, AUC(0-24)
categories
measurements
group Id
OG000
spread
192
value
18300
denoms
counts
group Id
OG000
value
3
units
Participants
title
185 mg, Cycle 1/Day 2, AUC(0-tlast)
categories
measurements
group Id
OG000
spread
217
value
14800
denoms
counts
group Id
OG000
value
3
units
Participants
title
185 mg, Cycle 2/Day 2, AUC(0-tlast)
categories
measurements
group Id
OG000
spread
193
value
18400
denoms
counts
group Id
OG000
value
3
units
Participants
title
185 mg, Cycle 1/Day 2, AUC(0-∞)
categories
measurements
group Id
OG000
spread
253
value
15700
denoms
counts
group Id
OG000
value
3
units
Participants
title
185 mg, Cycle 2/Day 2, AUC(0-∞)

denoms

counts
group Id
OG000
value
13
units
Participants

description

AUC from time zero to 24 hours (AUC\[0-24\]), AUC from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]), and AUC from time zero to infinity (AUC\[0-∞\]) values are reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.

dispersion Type

Geometric Coefficient of Variation

groups

description
Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
id
OG000
title
Phase 1: Pemetrexed + Cisplatin + LY2603618

param Type

GEOMETRIC_MEAN

population Description

Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.

reporting Status

POSTED

time Frame

Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose

title

Phase 1: Pharmacokinetic: Area Under the Plasma Concentration Versus Time Curve (AUC) (LY2603618)

type

SECONDARY

unit Of Measure

ng*h/mL

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

Preserved source evidence · Not medical advice