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NCT02573259 · OUTCOME

Trough PF-06801591 Concentrations (Ctrough) - Part 2

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
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose on Day 1 of Cycles 2-6, 9, 12, 15, 18, 21, 24, and Follow-up Day 28 in Part 2

What was measured

Trough PF-06801591 Concentrations (Ctrough) - Part 2. Ctrough was directly observed from data.

Analysis population: Analysis population included all participants who received PF-06801591, had no protocol deviations affecting the pharmacokinetics (PK) assessment, and had at least 1 post-dose concentration measurement above lower limit of quantification.

Groups in this outcome

Part 2: PF-06801591 300 mg (SC) for NSCLC

Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)

Part 2: PF-06801591 300 mg (SC) for UC

Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 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 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC39

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC58
Part 2: PF-06801591 300 mg (SC) for UC35
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC14.9748Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC14.3473Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC52
Part 2: PF-06801591 300 mg (SC) for UC27
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC22.5437Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC20.1584Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC42
Part 2: PF-06801591 300 mg (SC) for UC18
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC23.5553Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC23.7760Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC35
Part 2: PF-06801591 300 mg (SC) for UC17
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC23.5841Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC19.32186Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC29
Part 2: PF-06801591 300 mg (SC) for UC13
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC29.6736Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC17.13249Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC23
Part 2: PF-06801591 300 mg (SC) for UC12
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC29.0136Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC29.8830Not reportedNot reportedNot reported
Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC18
Part 2: PF-06801591 300 mg (SC) for UC8
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC34.2916Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC12.74770Not reportedNot reportedNot reported
Cycle 15 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC15
Part 2: PF-06801591 300 mg (SC) for UC9
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC40.9022Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC22.1056Not reportedNot reportedNot reported
Cycle 18 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC12
Part 2: PF-06801591 300 mg (SC) for UC6
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC35.0925Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC20.1775Not reportedNot reportedNot reported
Cycle 21 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC11
Part 2: PF-06801591 300 mg (SC) for UC5
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC27.1625Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC22.1155Not reportedNot reportedNot reported
Cycle 24 Day 1

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC7
Part 2: PF-06801591 300 mg (SC) for UC3
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC30.8116Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC38.0238Not reportedNot reportedNot reported
Follow-up Day 28

Analysis denominator · Participants

GroupSource count
Part 2: PF-06801591 300 mg (SC) for NSCLC5
Part 2: PF-06801591 300 mg (SC) for UC3
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC43.6233Not reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC35.1732Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        48
        value
        14.97
      2. group Id
        OG001
        spread
        73
        value
        14.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        37
        value
        22.54
      2. group Id
        OG001
        spread
        84
        value
        20.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        53
        value
        23.55
      2. group Id
        OG001
        spread
        60
        value
        23.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        41
        value
        23.58
      2. group Id
        OG001
        spread
        186
        value
        19.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        36
        value
        29.67
      2. group Id
        OG001
        spread
        249
        value
        17.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    Cycle 6 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        36
        value
        29.01
      2. group Id
        OG001
        spread
        30
        value
        29.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Cycle 9 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16
        value
        34.29
      2. group Id
        OG001
        spread
        770
        value
        12.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Cycle 12 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        22
        value
        40.90
      2. group Id
        OG001
        spread
        56
        value
        22.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Cycle 15 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        25
        value
        35.09
      2. group Id
        OG001
        spread
        75
        value
        20.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Cycle 18 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        25
        value
        27.16
      2. group Id
        OG001
        spread
        55
        value
        22.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Cycle 21 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        16
        value
        30.81
      2. group Id
        OG001
        spread
        38
        value
        38.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 24 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        33
        value
        43.62
      2. group Id
        OG001
        spread
        32
        value
        35.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Follow-up Day 28
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Trough PF-06801591 Concentrations (Ctrough) - Part 2. Ctrough was directly observed from data.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    OG000
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  2. description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    OG001
    title
    Part 2: PF-06801591 300 mg (SC) for UC
param Type
GEOMETRIC_MEAN
population Description
Analysis population included all participants who received PF-06801591, had no protocol deviations affecting the pharmacokinetics (PK) assessment, and had at least 1 post-dose concentration measurement above lower limit of quantification.
reporting Status
POSTED
time Frame
Pre-dose on Day 1 of Cycles 2-6, 9, 12, 15, 18, 21, 24, and Follow-up Day 28 in Part 2
title
Trough PF-06801591 Concentrations (Ctrough) - Part 2
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice