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NCT02659631 · OUTCOME

Maximum Serum Concentration (Cmax) 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
nanogram/milliliter (ng/mL)
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

Maximum serum concentration (Cmax) of PF-06671008 was observed directly from data. 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 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 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
Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PF-06671008 1.5 ng/kg IVNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
PF-06671008 7.5 ng/kg IVNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
PF-06671008 20 ng/kg IV0.192620Not reportedNot reportedNot reported
PF-06671008 50 ng/kg IVNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
PF-06671008 100 ng/kg IV1.10832Not reportedNot reportedNot reported
PF-06671008 200 ng/kg IV2.00833Not reportedNot reportedNot reported
PF-06671008 300 ng/kg IV2.38736Not reportedNot reportedNot reported
PF-06671008 400 ng/kg IV4.04914Not reportedNot reportedNot reported
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.
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IVNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
Cycle 2 Day 1

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 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 nanogram/milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PF-06671008 1.5 ng/kg IVNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
PF-06671008 7.5 ng/kg IVNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
PF-06671008 20 ng/kg IV0.247036Not reportedNot reportedNot reported
PF-06671008 50 ng/kg IVNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
PF-06671008 100 ng/kg IV0.847151Not reportedNot reportedNot reported
PF-06671008 200 ng/kg IV2.0147Not reportedNot reportedNot reported
PF-06671008 300 ng/kg IVNANANot reportedNot reportedSummary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
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.
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IVNANANot 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. 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
      2. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. group Id
        OG002
        spread
        20
        value
        0.1926
      4. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG003
        spread
        NA
        value
        NA
      5. group Id
        OG004
        spread
        32
        value
        1.108
      6. group Id
        OG005
        spread
        33
        value
        2.008
      7. group Id
        OG006
        spread
        36
        value
        2.387
      8. group Id
        OG007
        spread
        14
        value
        4.049
      9. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG008
        spread
        NA
        value
        NA
      10. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG009
        spread
        NA
        value
        NA
    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
    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
      2. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. group Id
        OG002
        spread
        36
        value
        0.2470
      4. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG003
        spread
        NA
        value
        NA
      5. group Id
        OG004
        spread
        51
        value
        0.8471
      6. group Id
        OG005
        spread
        7
        value
        2.014
      7. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG006
        spread
        NA
        value
        NA
      8. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG008
        spread
        NA
        value
        NA
      9. comment
        Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
        group Id
        OG009
        spread
        NA
        value
        NA
    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
        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
Maximum serum concentration (Cmax) of PF-06671008 was observed directly from data. 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 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
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
Maximum Serum Concentration (Cmax) of PF-06671008
type
SECONDARY
unit Of Measure
nanogram/milliliter (ng/mL)

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

Preserved source evidence · Not medical advice