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NCT01871727 · OUTCOME

Lead-In Part: Time to Response (TTR) 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
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 1 year 2 months)

What was measured

Time to response per investigator assessment was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment 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. Here, 'overall number of participants analyzed' were those who had CR or PR in lead-in part of the study.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Lead-In Part: E7777 6 mcg/kg1
Lead-In Part: E7777 9 mcg/kg4
Lead-In Part: E7777 12 mcg/kg3
Lead-In Part: E7777 15 mcg/kg0

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lead-In Part: E7777 6 mcg/kg106.0Not reported106.0106.0Not reported
Lead-In Part: E7777 9 mcg/kg53.5Not reported2285Not reported
Lead-In Part: E7777 12 mcg/kg64.0Not reported57106Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        106.0
        upper Limit
        106.0
        value
        106.0
      2. group Id
        OG001
        lower Limit
        22
        upper Limit
        85
        value
        53.5
      3. group Id
        OG002
        lower Limit
        57
        upper Limit
        106
        value
        64.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Time to response per investigator assessment was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment 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.
dispersion Type
Full Range
groups
  1. 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
  2. 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
  3. 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
  4. 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
param Type
MEDIAN
population Description
Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead-in part of the study.
reporting Status
POSTED
time Frame
From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 1 year 2 months)
title
Lead-In Part: Time to Response (TTR) Per Investigator Assessment
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice