NCT02418000 · OUTCOME

Overall Survival

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: MEDIAN
Unit: Days
Interval / dispersion: Standard Deviation
Time frame: From C1D1 until death or study closure, up to 26 months

What was measured

Length of time from the date of first administration of study drug to the date of death from any cause

Analysis population: The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified endpoint.

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	3
E6201 320 mg/m^2 Weekly	9
E6201 160 mg/m^2 Twice Weekly	2
E6201 240 mg/m^2 Twice Weekly	2
E6201 320 mg/m^2 Twice Weekly	3

Reported measurements

Source class 1

Values in Days · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
E6201 240 mg/m^2 Weekly	31	13.01	Not reported	Not reported	Not reported
E6201 320 mg/m^2 Weekly	68	50.39	Not reported	Not reported	Not reported
E6201 160 mg/m^2 Twice Weekly	96	69.30	Not reported	Not reported	Not reported
E6201 240 mg/m^2 Twice Weekly	99	48.08	Not reported	Not reported	Not reported
E6201 320 mg/m^2 Twice Weekly	30	35.37	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
13.01
value
31
group Id
OG001
spread
50.39
value
68
group Id
OG002
spread
69.30
value
96
group Id
OG003
spread
48.08
value
99
group Id
OG004
spread
35.37
value
30

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
9
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
3
units
Participants

description

Length of time from the date of first administration of study drug to the date of death from any cause

dispersion Type

Standard Deviation

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

MEDIAN

population Description

The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified endpoint.

reporting Status

POSTED

time Frame

From C1D1 until death or study closure, up to 26 months

title

Overall Survival

type

SECONDARY

unit Of Measure

Days

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

Preserved source evidence · Not medical advice