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NCT02676778 · OUTCOME

CL: Total Clearance for E7777

Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma · Source last updated 2021-07-15

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

Measure
MEAN
Unit
milliter per minute per kilogram
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)

What was measured

11 participants were included in the PK analysis, however CL, could not be estimated for 1 participant due to insufficient data for elimination rate constant.

Analysis population: The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available.

Groups in this outcome

PTCL and CTCL Participants: E7777 9 mcg/kg/Day

Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).

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

Analysis denominator · Participants

GroupSource count
PTCL and CTCL Participants: E7777 9 mcg/kg/Day11

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
PTCL and CTCL Participants: E7777 9 mcg/kg/Day10
Values in milliter per minute per kilogram · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PTCL and CTCL Participants: E7777 9 mcg/kg/Day0.4650.250Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
PTCL and CTCL Participants: E7777 9 mcg/kg/Day0
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
PTCL and CTCL Participants: E7777 9 mcg/kg/Day1
Values in milliter per minute per kilogram · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PTCL and CTCL Participants: E7777 9 mcg/kg/Day0.421NANot reportedNot reportedStandard deviation could not be calculated because only one participant was analysed.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.250
        value
        0.465
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Cycle 1 Day 1
  2. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. comment
        Standard deviation could not be calculated because only one participant was analysed.
        group Id
        OG000
        spread
        NA
        value
        0.421
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 5 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
11 participants were included in the PK analysis, however CL, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
    id
    OG000
    title
    PTCL and CTCL Participants: E7777 9 mcg/kg/Day
param Type
MEAN
population Description
The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available.
reporting Status
POSTED
time Frame
Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
title
CL: Total Clearance for E7777
type
SECONDARY
unit Of Measure
milliter per minute per kilogram

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice