NCT01183780 · OUTCOME

Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab

A Study in Second Line Metastatic Colorectal Cancer · Source last updated 2019-09-25

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

Measure: GEOMETRIC_MEAN
Unit: micrograms/milliliter (ug/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17

Analysis population: All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.

Groups in this outcome

Ramucirumab + FOLFIRI

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.

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
Ramucirumab + FOLFIRI	248

Reported measurements

Cmin Dose 3 (n=248)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	46.3	45.0	Not reported	Not reported	Not reported

Cmin Dose 5 (n=154)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	65.1	43.0	Not reported	Not reported	Not reported

Cmin Dose 9 (n=27)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	77.9	51.0	Not reported	Not reported	Not reported

Cmin Dose 13 (n=11)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	75.9	43.0	Not reported	Not reported	Not reported

Cmin Dose 17 (n=5)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	72.0	49.0	Not reported	Not reported	Not reported

Cmax Dose 3 (n=88)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	221.0	37.0	Not reported	Not reported	Not reported

Cmax Dose 5 (n=51)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	243.0	39.0	Not reported	Not reported	Not reported

Cmax Dose 9 (n=18)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	262.0	36.0	Not reported	Not reported	Not reported

Cmax Dose 13 (n=12)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	307.0	33.0	Not reported	Not reported	Not reported

Cmax Dose 17 (n=7)

Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + FOLFIRI	253.0	19.0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
45.0
value
46.3
title
Cmin Dose 3 (n=248)
categories
measurements
group Id
OG000
spread
43.0
value
65.1
title
Cmin Dose 5 (n=154)
categories
measurements
group Id
OG000
spread
51.0
value
77.9
title
Cmin Dose 9 (n=27)
categories
measurements
group Id
OG000
spread
43.0
value
75.9
title
Cmin Dose 13 (n=11)
categories
measurements
group Id
OG000
spread
49.0
value
72.0
title
Cmin Dose 17 (n=5)
categories
measurements
group Id
OG000
spread
37.0
value
221.0
title
Cmax Dose 3 (n=88)
categories
measurements
group Id
OG000
spread
39.0
value
243.0
title
Cmax Dose 5 (n=51)
categories
measurements
group Id
OG000
spread
36.0
value
262.0
title
Cmax Dose 9 (n=18)
categories
measurements
group Id
OG000
spread
33.0
value
307.0
title
Cmax Dose 13 (n=12)
categories
measurements
group Id
OG000
spread
19.0
value
253.0
title
Cmax Dose 17 (n=7)

denoms

counts
group Id
OG000
value
248
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
id
OG000
title
Ramucirumab + FOLFIRI

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.

reporting Status

POSTED

time Frame

Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17

title

Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab

type

SECONDARY

unit Of Measure

micrograms/milliliter (ug/mL)

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

Preserved source evidence · Independent clinical review pending · Not medical advice