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NCT03685591 · OUTCOME

Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) 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*hr/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 of cycle 1 and cycle 2

What was measured

AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.

Analysis population: Participants with 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*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1B: PF-06952229 250mg + Enzalutamide1694024Not reportedNot reportedNot reported
Part 1B: PF-06952229 375mg + Enzalutamide1343034Not 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*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1B: PF-06952229 250mg + Enzalutamide670785Not reportedNot reportedNot reported
Part 1B: PF-06952229 375mg + Enzalutamide565611Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24
        value
        16940
      2. group Id
        OG001
        spread
        34
        value
        13430
    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
        85
        value
        6707
      2. group Id
        OG001
        spread
        11
        value
        5656
    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
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured 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 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 of cycle 1 and cycle 2
title
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of PF-06952229 (Part 1B)
type
SECONDARY
unit Of Measure
ng*hr/mL

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

Preserved source evidence · Not medical advice