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NCT02573259 · OUTCOME

Clearance (CL) 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
L/hr
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1

What was measured

CL for IV dosing. CL was calculated by dose / AUCtau for Cycles 1 and 4 IV dosing. AUCtau was defined as area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for every 3 weeks (Q3W) IV dosing reporting arm.

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)

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)3
Part 1: PF-06801591 10 mg/kg (IV)4

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
Values in L/hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 1 mg/kg (IV)NANANot reportedNot reportedGeometric mean and geometric coefficient of variation 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])2
Part 1: PF-06801591 1 mg/kg (IV)2
Part 1: PF-06801591 3 mg/kg (IV)3
Part 1: PF-06801591 10 mg/kg (IV)4
Values in L/hr · 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)0.00604557Not reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0.00498414Not 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
        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
      units
      Participants
    title
    Cycle 1 Day 1
  2. 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. group Id
        OG002
        spread
        57
        value
        0.006045
      4. group Id
        OG003
        spread
        14
        value
        0.004984
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
      units
      Participants
    title
    Cycle 4 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    units
    Participants
description
CL for IV dosing. CL was calculated by dose / AUCtau for Cycles 1 and 4 IV dosing. AUCtau was defined as area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for every 3 weeks (Q3W) IV dosing reporting arm.
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)
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, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1
title
Clearance (CL) of PF-06801591 - Part 1
type
SECONDARY
unit Of Measure
L/hr

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Preserved source evidence · Not medical advice