Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01401530 · OUTCOME

Maximum Serum Concentration (Cmax) of Denileukin Diftitox

E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma · Source last updated 2018-11-23

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

Measure
MEDIAN
Unit
ng/mL
Interval / dispersion
Full Range
Time frame
Cycle 1 (Day 1)

What was measured

Cmax was defined as the maximum observed concentration of denileukin diftitox following administration of study treatment on Cycle 1 Day 1 and was obtained directly from the measured serum concentration-time curves. Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a lower limit of quantitation (LLOQ) of 30 nanograms per milliliter (ng/mL). Serum pharmacokinetic (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the median and full range for all participants and expressed as ng/mL.

Analysis population: PK analysis set included all participants in whom at least one PK parameter could be calculated.

Groups in this outcome

Cohort 1: 6 ug/kg/Day Denileukin Diftitox

Denileukin diftitox (6 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).

Cohort 2: 9 ug/kg/Day Denileukin Diftitox

Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).

Cohort 3: 12 ug/kg/Day Denileukin Diftitox

Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 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
Cohort 1: 6 ug/kg/Day Denileukin Diftitox3
Cohort 2: 9 ug/kg/Day Denileukin Diftitox5
Cohort 3: 12 ug/kg/Day Denileukin Diftitox2

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1: 6 ug/kg/Day Denileukin Diftitox129Not reported101130Not reported
Cohort 2: 9 ug/kg/Day Denileukin Diftitox149Not reported135245Not reported
Cohort 3: 12 ug/kg/Day Denileukin Diftitox181Not reported158204Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        101
        upper Limit
        130
        value
        129
      2. group Id
        OG001
        lower Limit
        135
        upper Limit
        245
        value
        149
      3. group Id
        OG002
        lower Limit
        158
        upper Limit
        204
        value
        181
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Cmax was defined as the maximum observed concentration of denileukin diftitox following administration of study treatment on Cycle 1 Day 1 and was obtained directly from the measured serum concentration-time curves. Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a lower limit of quantitation (LLOQ) of 30 nanograms per milliliter (ng/mL). Serum pharmacokinetic (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the median and full range for all participants and expressed as ng/mL.
dispersion Type
Full Range
groups
  1. description
    Denileukin diftitox (6 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    OG000
    title
    Cohort 1: 6 ug/kg/Day Denileukin Diftitox
  2. description
    Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    OG001
    title
    Cohort 2: 9 ug/kg/Day Denileukin Diftitox
  3. description
    Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    OG002
    title
    Cohort 3: 12 ug/kg/Day Denileukin Diftitox
param Type
MEDIAN
population Description
PK analysis set included all participants in whom at least one PK parameter could be calculated.
reporting Status
POSTED
time Frame
Cycle 1 (Day 1)
title
Maximum Serum Concentration (Cmax) of Denileukin Diftitox
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice