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NCT01871727 · OUTCOME

Main Study Part: Terminal Elimination Half-life (t1/2) 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
MEDIAN
Unit
minutes
Interval / dispersion
Full Range
Time frame
Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours 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 time points.

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

GroupSource count
Main Study Part: E7777 9 mcg/kg12

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Main Study Part: E7777 9 mcg/kg12
Values in minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg109Not reported58.9168Not reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Main Study Part: E7777 9 mcg/kg1
Values in minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg90.8Not reported90.890.8Not reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Main Study Part: E7777 9 mcg/kg1
Values in minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg51.7Not reported51.751.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.9
        upper Limit
        168
        value
        109
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90.8
        upper Limit
        90.8
        value
        90.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.7
        upper Limit
        51.7
        value
        51.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 5 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
dispersion Type
Full Range
groups
  1. 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
MEDIAN
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 time points.
reporting Status
POSTED
time Frame
Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
title
Main Study Part: Terminal Elimination Half-life (t1/2) of E7777
type
SECONDARY
unit Of Measure
minutes

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

Preserved source evidence · Not medical advice