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NCT02676778 · OUTCOME

Tmax: Time to Reach the Cmax 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
MEDIAN
Unit
minutes
Interval / dispersion
Full Range
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)

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/Day11
Values in minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
PTCL and CTCL Participants: E7777 9 mcg/kg/Day63.00Not reported59.0099.00Not reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
PTCL and CTCL Participants: E7777 9 mcg/kg/Day1
Values in minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
PTCL and CTCL Participants: E7777 9 mcg/kg/Day65.00Not reportedNANAFull range could not be calculated because only one participant was analysed.
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
PTCL and CTCL Participants: E7777 9 mcg/kg/Day1
Values in minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
PTCL and CTCL Participants: E7777 9 mcg/kg/Day80.00Not reportedNANAFull range could not be calculated because only one participant was analysed.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.00
        upper Limit
        99.00
        value
        63.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. comment
        Full range could not be calculated because only one participant was analysed.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        65.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. comment
        Full range could not be calculated because only one participant was analysed.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        80.00
    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
dispersion Type
Full Range
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
MEDIAN
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
Tmax: Time to Reach the Cmax for E7777
type
SECONDARY
unit Of Measure
minutes

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

Preserved source evidence · Not medical advice