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NCT02659631 · OUTCOME

Apparent Clearance (CL/F) of PF-06671008

PF-06671008 Dose Escalation Study in Advanced Solid Tumors · Source last updated 2020-05-06

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

Measure
GEOMETRIC_MEAN
Unit
mL/hr/kg
Interval / dispersion
Geometric Coefficient of Variation
Time frame
C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose

What was measured

Apparent Clearance (CL/F) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arm. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.

Analysis population: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.

Groups in this outcome

PF-06671008 200 ng/kg SC

PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.

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

Analysis denominator · Participants

GroupSource count
PF-06671008 200 ng/kg SC2

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
PF-06671008 200 ng/kg SC0
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
PF-06671008 200 ng/kg SC2
Values in mL/hr/kg · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PF-06671008 200 ng/kg SCNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Apparent Clearance (CL/F) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arm. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
    id
    OG000
    title
    PF-06671008 200 ng/kg SC
param Type
GEOMETRIC_MEAN
population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
reporting Status
POSTED
time Frame
C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
title
Apparent Clearance (CL/F) of PF-06671008
type
SECONDARY
unit Of Measure
mL/hr/kg

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

Preserved source evidence · Not medical advice