Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03685591 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of PF-06952229 (Part 1B)

PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors · Source last updated 2024-06-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 and 21 of cycle 1, 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 2.

What was measured

Cmax was directly observed from data. Cmax was defined as maximum observed plasma concentration.

Analysis population: Participants with metastatic castration-resistant prostate cancer (mCRPC), conducted dose escalation of PF-06952229 in combination with enzalutamide, who had sufficient information to estimate at least 1 of the PK parameters of interest. Here, "number analyzed" signifies participant evaluable for each row

Groups in this outcome

Part 1B: PF-06952229 250mg + Enzalutamide

PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.

Part 1B: PF-06952229 375mg + Enzalutamide

PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.

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 1B: PF-06952229 250mg + Enzalutamide4
Part 1B: PF-06952229 375mg + Enzalutamide3

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Part 1B: PF-06952229 250mg + Enzalutamide4
Part 1B: PF-06952229 375mg + Enzalutamide3
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1B: PF-06952229 250mg + Enzalutamide161945Not reportedNot reportedNot reported
Part 1B: PF-06952229 375mg + Enzalutamide146221Not reportedNot reportedNot reported
Cycle 1 Day 21

Analysis denominator · Participants

GroupSource count
Part 1B: PF-06952229 250mg + Enzalutamide3
Part 1B: PF-06952229 375mg + Enzalutamide3
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1B: PF-06952229 250mg + Enzalutamide128935Not reportedNot reportedNot reported
Part 1B: PF-06952229 375mg + Enzalutamide150032Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Part 1B: PF-06952229 250mg + Enzalutamide3
Part 1B: PF-06952229 375mg + Enzalutamide3
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1B: PF-06952229 250mg + Enzalutamide693.584Not reportedNot reportedNot reported
Part 1B: PF-06952229 375mg + Enzalutamide960.313Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        45
        value
        1619
      2. group Id
        OG001
        spread
        21
        value
        1462
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        35
        value
        1289
      2. group Id
        OG001
        spread
        32
        value
        1500
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 Day 21
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        84
        value
        693.5
      2. group Id
        OG001
        spread
        13
        value
        960.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Cmax was directly observed from data. Cmax was defined as maximum observed plasma concentration.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
    id
    OG000
    title
    Part 1B: PF-06952229 250mg + Enzalutamide
  2. description
    PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
    id
    OG001
    title
    Part 1B: PF-06952229 375mg + Enzalutamide
param Type
GEOMETRIC_MEAN
population Description
Participants with metastatic castration-resistant prostate cancer (mCRPC), conducted dose escalation of PF-06952229 in combination with enzalutamide, who had sufficient information to estimate at least 1 of the PK parameters of interest. Here, "number analyzed" signifies participant evaluable for each row
reporting Status
POSTED
time Frame
0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 and 21 of cycle 1, 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 2.
title
Maximum Observed Plasma Concentration (Cmax) of PF-06952229 (Part 1B)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice