NCT02418000 · OUTCOME

Number of Participants With Suppression of pERK at 4 Hours Post-dose

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Cycle 1 Day 1, 4 hours post-dose.

What was measured

phospho-ERK (pERK) in blood assessed by Western blot at 4 hours post-dose

Analysis population: All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.

Groups in this outcome

E6201 240 mg/m^2 Weekly

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

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

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

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

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 Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
E6201 240 mg/m^2 Weekly	3	Not reported	Not reported	Not reported	Not reported
E6201 320 mg/m^2 Weekly	2	Not reported	Not reported	Not reported	Not reported
E6201 160 mg/m^2 Twice Weekly	2	Not reported	Not reported	Not reported	Not reported
E6201 240 mg/m^2 Twice Weekly	2	Not reported	Not reported	Not reported	Not reported
E6201 320 mg/m^2 Twice Weekly	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
1

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

phospho-ERK (pERK) in blood assessed by Western blot at 4 hours post-dose

groups

description
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
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
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
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
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

COUNT_OF_PARTICIPANTS

population Description

All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.

reporting Status

POSTED

time Frame

Cycle 1 Day 1, 4 hours post-dose.

title

Number of Participants With Suppression of pERK at 4 Hours Post-dose

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice