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NCT02573259 · OUTCOME

Accumulation Ratio (Rac) 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
GEOMETRIC_MEAN
Unit
Ratio
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1

What was measured

Rac was calculated by (Cycle 4 AUCtau) / (Cycle 1 AUCtau). AUCtau was Area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for Q3W IV dosing and tau = 672 hours for every 4 weeks (Q4W) SC dosing.

Analysis population: Analysis population included all enrolled participants treated who were evaluable for this outcome measure.

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)2
Part 1: PF-06801591 3 mg/kg (IV)2
Part 1: PF-06801591 10 mg/kg (IV)4
Part 1: PF-06801591 300 mg (Subcutaneously [SC])3

Reported measurements

Source class 1
Values in Ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANANot reportedNot reportedGeometric mean and geometric coefficient of variation were not reported for n \< 3.
Part 1: PF-06801591 1 mg/kg (IV)NANANot reportedNot reportedGeometric mean and geometric coefficient of variation were not reported for n \< 3.
Part 1: PF-06801591 3 mg/kg (IV)NANANot reportedNot reportedGeometric mean and geometric coefficient of variation were not reported for n \< 3.
Part 1: PF-06801591 10 mg/kg (IV)2.36012Not reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])2.07331Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Geometric mean and geometric coefficient of variation were not reported for n \< 3.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Geometric mean and geometric coefficient of variation were not reported for n \< 3.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Geometric mean and geometric coefficient of variation were not reported for n \< 3.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        12
        value
        2.360
      5. group Id
        OG004
        spread
        31
        value
        2.073
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      3
    units
    Participants
description
Rac was calculated by (Cycle 4 AUCtau) / (Cycle 1 AUCtau). AUCtau was Area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for Q3W IV dosing and tau = 672 hours for every 4 weeks (Q4W) SC dosing.
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
population Description
Analysis population included all enrolled participants treated who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1
title
Accumulation Ratio (Rac) of PF-06801591 - Part 1
type
SECONDARY
unit Of Measure
Ratio

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Preserved source evidence · Not medical advice