NCT01871727 · OUTCOME

Lead-In Part and Main Study Part: ORR Per Investigator Assessment

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: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)

What was measured

ORR per investigator assessment was defined as the percentage of participants whose BOR was CR or PR. The tumor response was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.

Analysis population: Lead-in analysis set included all participants enrolled in the lead-in part and Investigator efficacy analysis set included all Stage I to III participants (both Main Study \[n=66\] and Lead-In \[n=5\]) who received study drug at 9 mcg/kg dose.

Groups in this outcome

Lead-In Part: E7777 6 mcg/kg

Participants were treated with E7777 6 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.

Lead-In Part: E7777 9 mcg/kg

Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.

Lead-In Part: E7777 12 mcg/kg

Participants were treated with E7777 12 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.

Lead-In Part: E7777 15 mcg/kg

Participants were treated with E7777 15 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.

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
Lead-In Part: E7777 6 mcg/kg	2
Lead-In Part: E7777 9 mcg/kg	8
Lead-In Part: E7777 12 mcg/kg	9
Lead-In Part: E7777 15 mcg/kg	2
Main Study Part: E7777 9 mcg/kg	71

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lead-In Part: E7777 6 mcg/kg	50.0	Not reported	1.3	98.7	Not reported
Lead-In Part: E7777 9 mcg/kg	50.0	Not reported	15.7	84.3	Not reported
Lead-In Part: E7777 12 mcg/kg	33.3	Not reported	7.5	70.1	Not reported
Lead-In Part: E7777 15 mcg/kg	0	Not reported	0	84.2	Not reported
Main Study Part: E7777 9 mcg/kg	42.3	Not reported	30.6	54.6	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.3
upper Limit
98.7
value
50.0
group Id
OG001
lower Limit
15.7
upper Limit
84.3
value
50.0
group Id
OG002
lower Limit
7.5
upper Limit
70.1
value
33.3
group Id
OG003
lower Limit
0
upper Limit
84.2
value
0
group Id
OG004
lower Limit
30.6
upper Limit
54.6
value
42.3

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
8
group Id
OG002
value
9
group Id
OG003
value
2
group Id
OG004
value
71
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants were treated with E7777 6 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.
id
OG000
title
Lead-In Part: E7777 6 mcg/kg
description
Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
id
OG001
title
Lead-In Part: E7777 9 mcg/kg
description
Participants were treated with E7777 12 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.
id
OG002
title
Lead-In Part: E7777 12 mcg/kg
description
Participants were treated with E7777 15 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.
id
OG003
title
Lead-In Part: E7777 15 mcg/kg
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
OG004
title
Main Study Part: E7777 9 mcg/kg

param Type

NUMBER

population Description

Lead-in analysis set included all participants enrolled in the lead-in part and Investigator efficacy analysis set included all Stage I to III participants (both Main Study \[n=66\] and Lead-In \[n=5\]) who received study drug at 9 mcg/kg dose.

reporting Status

POSTED

time Frame

From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)

title

Lead-In Part and Main Study Part: ORR Per Investigator Assessment

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice