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NCT01871727 · OUTCOME

Lead-In Part: Maximum Tolerated Dose (MTD) 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
NUMBER
Unit
mcg/kg
Interval / dispersion
Not reported
Time frame
Cycle 1 (cycle length was 21 days)

What was measured

The MTD was defined as the safe dose level established in Lead-In Part. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the Lead-In Part.

Analysis population: Dose-finding analysis set included all participants in the Lead-in part who completed Cycle 1 treatment and were evaluated for DLT, and those who discontinued during Cycle 1 due to DLT.

Groups in this outcome

Lead-In Part: E7777

Participants were treated with E7777 6, 9, 12 and 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: E777721

Reported measurements

Source class 1
Values in mcg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-In Part: E777712.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12.0
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
The MTD was defined as the safe dose level established in Lead-In Part. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the Lead-In Part.
groups
  1. description
    Participants were treated with E7777 6, 9, 12 and 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
    OG000
    title
    Lead-In Part: E7777
param Type
NUMBER
population Description
Dose-finding analysis set included all participants in the Lead-in part who completed Cycle 1 treatment and were evaluated for DLT, and those who discontinued during Cycle 1 due to DLT.
reporting Status
POSTED
time Frame
Cycle 1 (cycle length was 21 days)
title
Lead-In Part: Maximum Tolerated Dose (MTD) of E7777
type
PRIMARY
unit Of Measure
mcg/kg

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

Preserved source evidence · Not medical advice