NCT02418000 · OUTCOME

Pharmacokinetic Profile of E6201 in Plasma: CLobs

A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations · Source last updated 2019-03-20

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

Measure: MEAN
Unit: L/h
Interval / dispersion: Standard Deviation
Time frame: Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.

What was measured

Clearance observed (CLobs): Total body clearance for extravascular administration

Analysis population: All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.

Groups in this outcome

E6201 240 mg/m^2 Weekly

Cohort 1: Participants were administered E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.

E6201 320 mg/m^2 Weekly

Cohort 2: Participants were administered E6201 320 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.

E6201 160 mg/m^2 Twice Weekly

Cohort 3: Participants were administered E6201 160 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.

E6201 240 mg/m^2 Twice Weekly

Cohort 4: Participants were administered E6201 240 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.

E6201 320 mg/m^2 Twice Weekly

Cohort 5: Participants were administered E6201 320 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.

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
E6201 240 mg/m^2 Weekly	7
E6201 320 mg/m^2 Weekly	10
E6201 160 mg/m^2 Twice Weekly	3
E6201 240 mg/m^2 Twice Weekly	3
E6201 320 mg/m^2 Twice Weekly	4

Reported measurements

Source class 1

Values in L/h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
E6201 240 mg/m^2 Weekly	104.0	17.8	Not reported	Not reported	Not reported
E6201 320 mg/m^2 Weekly	300.2	45.3	Not reported	Not reported	Not reported
E6201 160 mg/m^2 Twice Weekly	150.68	15.3	Not reported	Not reported	Not reported
E6201 240 mg/m^2 Twice Weekly	221.2	70.1	Not reported	Not reported	Not reported
E6201 320 mg/m^2 Twice Weekly	85.7	33.1	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
17.8
value
104.0
group Id
OG001
spread
45.3
value
300.2
group Id
OG002
spread
15.3
value
150.68
group Id
OG003
spread
70.1
value
221.2
group Id
OG004
spread
33.1
value
85.7

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
10
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
4
units
Participants

description

Clearance observed (CLobs): Total body clearance for extravascular administration

dispersion Type

Standard Deviation

groups

description
Cohort 1: Participants were administered E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
id
OG000
title
E6201 240 mg/m^2 Weekly
description
Cohort 2: Participants were administered E6201 320 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
id
OG001
title
E6201 320 mg/m^2 Weekly
description
Cohort 3: Participants were administered E6201 160 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
id
OG002
title
E6201 160 mg/m^2 Twice Weekly
description
Cohort 4: Participants were administered E6201 240 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
id
OG003
title
E6201 240 mg/m^2 Twice Weekly
description
Cohort 5: Participants were administered E6201 320 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
id
OG004
title
E6201 320 mg/m^2 Twice Weekly

param Type

MEAN

population Description

All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.

reporting Status

POSTED

time Frame

Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.

title

Pharmacokinetic Profile of E6201 in Plasma: CLobs

type

SECONDARY

unit Of Measure

L/h

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Preserved source evidence · Not medical advice