NCT03245450 · OUTCOME

Phase 1, AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of Eribulin, Irinotecan and Its Active Metabolite SN-38

Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors · Source last updated 2022-06-28

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

Measure: GEOMETRIC_MEAN
Unit: hour*nanogram per milliliter (h*ng/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: For eribulin, Cycle 1 Day 1: 0-120 hours post-eribulin infusion; For irinotecan and its metabolite, Cycle 1 Day 1: 0-24 hours post-irinotecan infusion (cycle length=21 days)

Analysis population: PK analysis set included participants who had documented dosing history and at least one post-dosing quantifiable drug concentration.

Groups in this outcome

Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2

Participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.

Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2

Participants received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.

Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2

Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 100 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.

Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2

Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 125 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.

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: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2	3
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2	4
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2	3
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2	3

Reported measurements

Eribulin

Values in hour*nanogram per milliliter (h*ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2	422.5	40.0	40.0	Not reported	Not reported
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2	403.7	32.1	32.1	Not reported	Not reported
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2	616.9	66.1	66.1	Not reported	Not reported
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2	603.5	87.3	87.3	Not reported	Not reported

Irinotecan

Values in hour*nanogram per milliliter (h*ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2	1812.6	13.5	13.5	Not reported	Not reported
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2	3686.1	36.4	36.4	Not reported	Not reported
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2	4693.9	66.1	66.1	Not reported	Not reported
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2	3633.7	38.9	38.9	Not reported	Not reported

Metabolite SN-38

Values in hour*nanogram per milliliter (h*ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2	68.00	19.7	19.7	Not reported	Not reported
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2	145.04	11.6	11.6	Not reported	Not reported
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2	138.22	42.2	42.2	Not reported	Not reported
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2	65.47	153.2	153.2	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
40.0
spread
40.0
value
422.5
group Id
OG001
lower Limit
32.1
spread
32.1
value
403.7
group Id
OG002
lower Limit
66.1
spread
66.1
value
616.9
group Id
OG003
lower Limit
87.3
spread
87.3
value
603.5
title
Eribulin
categories
measurements
group Id
OG000
lower Limit
13.5
spread
13.5
value
1812.6
group Id
OG001
lower Limit
36.4
spread
36.4
value
3686.1
group Id
OG002
lower Limit
66.1
spread
66.1
value
4693.9
group Id
OG003
lower Limit
38.9
spread
38.9
value
3633.7
title
Irinotecan
categories
measurements
group Id
OG000
lower Limit
19.7
spread
19.7
value
68.00
group Id
OG001
lower Limit
11.6
spread
11.6
value
145.04
group Id
OG002
lower Limit
42.2
spread
42.2
value
138.22
group Id
OG003
lower Limit
153.2
spread
153.2
value
65.47
title
Metabolite SN-38

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
3
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
OG000
title
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2
description
Participants received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
OG001
title
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
description
Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 100 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
OG002
title
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2
description
Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 125 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
OG003
title
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2

param Type

GEOMETRIC_MEAN

population Description

PK analysis set included participants who had documented dosing history and at least one post-dosing quantifiable drug concentration.

reporting Status

POSTED

time Frame

For eribulin, Cycle 1 Day 1: 0-120 hours post-eribulin infusion; For irinotecan and its metabolite, Cycle 1 Day 1: 0-24 hours post-irinotecan infusion (cycle length=21 days)

title

Phase 1, AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of Eribulin, Irinotecan and Its Active Metabolite SN-38

type

SECONDARY

unit Of Measure

hour*nanogram per milliliter (h*ng/mL)

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Preserved source evidence · Not medical advice