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NCT03685591 · OUTCOME

Time of Observed Maximum Plasma Concentration (Tmax) 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
MEDIAN
Unit
hour (hr)
Interval / dispersion
Full Range
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

Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.

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 hour (hr) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1B: PF-06952229 250mg + Enzalutamide2.20Not reported2.035.73Not reported
Part 1B: PF-06952229 375mg + Enzalutamide1.98Not reported1.952.00Not reported
Cycle 1 Day 21

Analysis denominator · Participants

GroupSource count
Part 1B: PF-06952229 250mg + Enzalutamide3
Part 1B: PF-06952229 375mg + Enzalutamide3
Values in hour (hr) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1B: PF-06952229 250mg + Enzalutamide1.00Not reported0.9672.20Not reported
Part 1B: PF-06952229 375mg + Enzalutamide0.983Not reported0.9171.85Not reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Part 1B: PF-06952229 250mg + Enzalutamide3
Part 1B: PF-06952229 375mg + Enzalutamide3
Values in hour (hr) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1B: PF-06952229 250mg + Enzalutamide2.05Not reported1.833.68Not reported
Part 1B: PF-06952229 375mg + Enzalutamide2.00Not reported1.952.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.03
        upper Limit
        5.73
        value
        2.20
      2. group Id
        OG001
        lower Limit
        1.95
        upper Limit
        2.00
        value
        1.98
    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
        lower Limit
        0.967
        upper Limit
        2.20
        value
        1.00
      2. group Id
        OG001
        lower Limit
        0.917
        upper Limit
        1.85
        value
        0.983
    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
        lower Limit
        1.83
        upper Limit
        3.68
        value
        2.05
      2. group Id
        OG001
        lower Limit
        1.95
        upper Limit
        2.00
        value
        2.00
    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
Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.
dispersion Type
Full Range
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
MEDIAN
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 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
Time of Observed Maximum Plasma Concentration (Tmax) of PF-06952229 (Part 1B)
type
SECONDARY
unit Of Measure
hour (hr)

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

Preserved source evidence · Not medical advice