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NCT02573259 · OUTCOME

Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1

A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13

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

Measure
MEAN
Unit
Days
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1

What was measured

t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.

Analysis population: The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV or SC administration and had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of t1/2.

Groups in this outcome

Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])

Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)

Part 1: PF-06801591 1 mg/kg (IV)

Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)

Part 1: PF-06801591 3 mg/kg (IV)

Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)

Part 1: PF-06801591 10 mg/kg (IV)

Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)

Part 1: PF-06801591 300 mg (Subcutaneously [SC])

Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)

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

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)8
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0
Part 1: PF-06801591 1 mg/kg (IV)1
Part 1: PF-06801591 3 mg/kg (IV)0
Part 1: PF-06801591 10 mg/kg (IV)0
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 1 mg/kg (IV)NANANot reportedNot reportedMean and standard deviation were not reported for n\<3.
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0
Part 1: PF-06801591 1 mg/kg (IV)0
Part 1: PF-06801591 3 mg/kg (IV)0
Part 1: PF-06801591 10 mg/kg (IV)0
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANANot reportedNot reportedMean and standard deviation were not reported for n\<3.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Mean and standard deviation were not reported for n\<3.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. comment
        Mean and standard deviation were not reported for n\<3.
        group Id
        OG004
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Cycle 4 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      15
    units
    Participants
description
t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
    id
    OG000
    title
    Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
  2. description
    Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
    id
    OG001
    title
    Part 1: PF-06801591 1 mg/kg (IV)
  3. description
    Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
    id
    OG002
    title
    Part 1: PF-06801591 3 mg/kg (IV)
  4. description
    Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
    id
    OG003
    title
    Part 1: PF-06801591 10 mg/kg (IV)
  5. description
    Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
    id
    OG004
    title
    Part 1: PF-06801591 300 mg (Subcutaneously [SC])
param Type
MEAN
population Description
The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV or SC administration and had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of t1/2.
reporting Status
POSTED
time Frame
Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1
title
Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1
type
SECONDARY
unit Of Measure
Days

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Preserved source evidence · Not medical advice