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NCT02659631 · OUTCOME

Time to Reach Maximum Observed Serum Concentration (Tmax) 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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
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

Time for Maximum serum concentration (Tmax) of PF-06671008 was observed directly from data as time of first occurrence.

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 1.5 ng/kg IV

PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 7.5 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.

PF-06671008 20 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 50 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.

PF-06671008 100 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 200 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.

PF-06671008 300 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 400 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.

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.

PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 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 1.5 ng/kg IV1
PF-06671008 7.5 ng/kg IV2
PF-06671008 20 ng/kg IV3
PF-06671008 50 ng/kg IV2
PF-06671008 100 ng/kg IV4
PF-06671008 200 ng/kg IV5
PF-06671008 300 ng/kg IV4
PF-06671008 400 ng/kg IV3
PF-06671008 200 ng/kg SC2
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV1

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
PF-06671008 1.5 ng/kg IV0
PF-06671008 7.5 ng/kg IV1
PF-06671008 20 ng/kg IV3
PF-06671008 50 ng/kg IV2
PF-06671008 100 ng/kg IV4
PF-06671008 200 ng/kg IV5
PF-06671008 300 ng/kg IV4
PF-06671008 400 ng/kg IV3
PF-06671008 200 ng/kg SC2
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV1
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
PF-06671008 7.5 ng/kg IV2.02Not reported2.022.02Not reported
PF-06671008 20 ng/kg IV4.05Not reported2.004.08Not reported
PF-06671008 50 ng/kg IV2.29Not reported1.922.65Not reported
PF-06671008 100 ng/kg IV2.07Not reported2.004.10Not reported
PF-06671008 200 ng/kg IV2.33Not reported2.003.98Not reported
PF-06671008 300 ng/kg IV2.17Not reported2.053.63Not reported
PF-06671008 400 ng/kg IV2.05Not reported2.053.00Not reported
PF-06671008 200 ng/kg SC50.5Not reported8.1292.9Not reported
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV1.92Not reported1.921.92Not reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
PF-06671008 1.5 ng/kg IV0
PF-06671008 7.5 ng/kg IV1
PF-06671008 20 ng/kg IV3
PF-06671008 50 ng/kg IV1
PF-06671008 100 ng/kg IV3
PF-06671008 200 ng/kg IV4
PF-06671008 300 ng/kg IV2
PF-06671008 400 ng/kg IV0
PF-06671008 200 ng/kg SC2
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV1
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
PF-06671008 7.5 ng/kg IV2.12Not reported2.122.12Not reported
PF-06671008 20 ng/kg IV3.98Not reported2.004.22Not reported
PF-06671008 50 ng/kg IV3.90Not reported3.903.90Not reported
PF-06671008 100 ng/kg IV4.00Not reported2.174.28Not reported
PF-06671008 200 ng/kg IV2.09Not reported1.922.17Not reported
PF-06671008 300 ng/kg IV2.14Not reported2.102.17Not reported
PF-06671008 200 ng/kg SC24.6Not reported23.425.7Not reported
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV1.98Not reported1.981.98Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        2.02
        upper Limit
        2.02
        value
        2.02
      2. group Id
        OG002
        lower Limit
        2.00
        upper Limit
        4.08
        value
        4.05
      3. group Id
        OG003
        lower Limit
        1.92
        upper Limit
        2.65
        value
        2.29
      4. group Id
        OG004
        lower Limit
        2.00
        upper Limit
        4.10
        value
        2.07
      5. group Id
        OG005
        lower Limit
        2.00
        upper Limit
        3.98
        value
        2.33
      6. group Id
        OG006
        lower Limit
        2.05
        upper Limit
        3.63
        value
        2.17
      7. group Id
        OG007
        lower Limit
        2.05
        upper Limit
        3.00
        value
        2.05
      8. group Id
        OG008
        lower Limit
        8.12
        upper Limit
        92.9
        value
        50.5
      9. group Id
        OG009
        lower Limit
        1.92
        upper Limit
        1.92
        value
        1.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        1
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        2.12
        upper Limit
        2.12
        value
        2.12
      2. group Id
        OG002
        lower Limit
        2.00
        upper Limit
        4.22
        value
        3.98
      3. group Id
        OG003
        lower Limit
        3.90
        upper Limit
        3.90
        value
        3.90
      4. group Id
        OG004
        lower Limit
        2.17
        upper Limit
        4.28
        value
        4.00
      5. group Id
        OG005
        lower Limit
        1.92
        upper Limit
        2.17
        value
        2.09
      6. group Id
        OG006
        lower Limit
        2.10
        upper Limit
        2.17
        value
        2.14
      7. group Id
        OG008
        lower Limit
        23.4
        upper Limit
        25.7
        value
        24.6
      8. group Id
        OG009
        lower Limit
        1.98
        upper Limit
        1.98
        value
        1.98
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        1
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      2
    10. group Id
      OG009
      value
      1
    units
    Participants
description
Time for Maximum serum concentration (Tmax) of PF-06671008 was observed directly from data as time of first occurrence.
dispersion Type
Full Range
groups
  1. description
    PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG000
    title
    PF-06671008 1.5 ng/kg IV
  2. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
    id
    OG001
    title
    PF-06671008 7.5 ng/kg IV
  3. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG002
    title
    PF-06671008 20 ng/kg IV
  4. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    OG003
    title
    PF-06671008 50 ng/kg IV
  5. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG004
    title
    PF-06671008 100 ng/kg IV
  6. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
    id
    OG005
    title
    PF-06671008 200 ng/kg IV
  7. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG006
    title
    PF-06671008 300 ng/kg IV
  8. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    OG007
    title
    PF-06671008 400 ng/kg IV
  9. 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
    OG008
    title
    PF-06671008 200 ng/kg SC
  10. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG009
    title
    PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
param Type
MEDIAN
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
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06671008
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice