NCT01494506 · OUTCOME

Pharmacokinetic Measurements of Total Irinotecan

Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer · Source last updated 2016-06-17

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

Measure: GEOMETRIC_MEAN
Unit: Total irinotecan = ug/L; SN38= ug/L
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 6 weeks after first study drug administration

What was measured

Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.

Analysis population: PK population was based on Protocol, all participants who received the appropriate dose of MM-398.

Groups in this outcome

MM-398 Arm A (Mono Therapy Comparison)

• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.

MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison

* MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2. * 5-FU 2400 mg/m2 IV over 46-hours, and * Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks

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
MM-398 Arm A (Mono Therapy Comparison)	143
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison	114

Reported measurements

Total Irinotecan-Cavg

Values in Total irinotecan = ug/L; SN38= ug/L · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MM-398 Arm A (Mono Therapy Comparison)	2550.00	197.4	Not reported	Not reported	Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison	2120.00	209.7	Not reported	Not reported	Not reported

Total Irinotecan-Cmax

Values in Total irinotecan = ug/L; SN38= ug/L · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MM-398 Arm A (Mono Therapy Comparison)	40550.00	172.3	Not reported	Not reported	Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison	28460.00	69.3	Not reported	Not reported	Not reported

Total SN38-Cavg

Values in Total irinotecan = ug/L; SN38= ug/L · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MM-398 Arm A (Mono Therapy Comparison)	0.82	119.2	Not reported	Not reported	Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison	0.68	132.7	Not reported	Not reported	Not reported

Total SN38-Cmax

Values in Total irinotecan = ug/L; SN38= ug/L · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MM-398 Arm A (Mono Therapy Comparison)	3.93	119.6	Not reported	Not reported	Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison	2.58	121.9	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
197.4
value
2550.00
group Id
OG001
spread
209.7
value
2120.00
title
Total Irinotecan-Cavg
categories
measurements
group Id
OG000
spread
172.3
value
40550.00
group Id
OG001
spread
69.3
value
28460.00
title
Total Irinotecan-Cmax
categories
measurements
group Id
OG000
spread
119.2
value
0.82
group Id
OG001
spread
132.7
value
0.68
title
Total SN38-Cavg
categories
measurements
group Id
OG000
spread
119.6
value
3.93
group Id
OG001
spread
121.9
value
2.58
title
Total SN38-Cmax

denoms

counts
group Id
OG000
value
143
group Id
OG001
value
114
units
Participants

description

Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.

dispersion Type

Geometric Coefficient of Variation

groups

description
• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
id
OG000
title
MM-398 Arm A (Mono Therapy Comparison)
description
* MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2. * 5-FU 2400 mg/m2 IV over 46-hours, and * Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks
id
OG001
title
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison

param Type

GEOMETRIC_MEAN

population Description

PK population was based on Protocol, all participants who received the appropriate dose of MM-398.

reporting Status

POSTED

time Frame

6 weeks after first study drug administration

title

Pharmacokinetic Measurements of Total Irinotecan

type

SECONDARY

unit Of Measure

Total irinotecan = ug/L; SN38= ug/L

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Preserved source evidence · Not medical advice