NCT01871727 · OUTCOME

Main Study Part: Maximum Serum Concentration (Cmax) of E7777

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma · Source last updated 2024-11-13

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

Measure: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 minutes post-dose (Cycle length was 21 days)

Analysis population: Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given timepoints.

Groups in this outcome

Main Study Part: E7777 9 mcg/kg

Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.

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
Main Study Part: E7777 9 mcg/kg	20

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Main Study Part: E7777 9 mcg/kg	20

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study Part: E7777 9 mcg/kg	114	62.5	Not reported	Not reported	Not reported

Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Main Study Part: E7777 9 mcg/kg	16

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study Part: E7777 9 mcg/kg	37.5	19.4	Not reported	Not reported	Not reported

Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Main Study Part: E7777 9 mcg/kg	12

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study Part: E7777 9 mcg/kg	45.5	46.8	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
62.5
value
114
denoms
counts
group Id
OG000
value
20
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
19.4
value
37.5
denoms
counts
group Id
OG000
value
16
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
46.8
value
45.5
denoms
counts
group Id
OG000
value
12
units
Participants
title
Cycle 5 Day 1

denoms

counts
group Id
OG000
value
20
units
Participants

dispersion Type

Standard Deviation

groups

description
Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
id
OG000
title
Main Study Part: E7777 9 mcg/kg

param Type

MEAN

population Description

Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given timepoints.

reporting Status

POSTED

time Frame

Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 minutes post-dose (Cycle length was 21 days)

title

Main Study Part: Maximum Serum Concentration (Cmax) of E7777

type

SECONDARY

unit Of Measure

ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice