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NCT01942135 · OUTCOME

Observed Plasma Trough Concentration (Ctrough) for Palbociclib

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) · Source last updated 2024-04-04

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

Measure
GEOMETRIC_MEAN
Unit
nanograms per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1/Day 15 and Cycle 2/Day 15

What was measured

Ctrough was defined as steady-state predose concentration. Observed directly from data. For palbociclib, a steady-state trough was to be defined as a predose plasma concentration following at least 8 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 22 and 26 hours after the dose (the day prior to PK collection) and no more than 1 hour post-dose on the day of PK collection.

Analysis population: The participants who were treated with Palbociclib + fulvestrant (with or without goserelin) or placebo + fulvestrant (with or without goserelin) and have at least one measured plasma drug concentration. The geometric mean and coefficient of variation was not estimable for Cycle 1/Day 15 and Cycle 2/Day 15 for the reporting arm placebo plus fulvestrant.

Groups in this outcome

Palbociclib + Fulvestrant

Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Palbociclib + Fulvestrant325

Reported measurements

Cycle 1/Day 15

Analysis denominator · Participants

GroupSource count
Palbociclib + Fulvestrant165
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Palbociclib + Fulvestrant70.7044Not reportedNot reportedNot reported
Cycle 2/Day 15

Analysis denominator · Participants

GroupSource count
Palbociclib + Fulvestrant160
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Palbociclib + Fulvestrant75.2944Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        44
        value
        70.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        165
      units
      Participants
    title
    Cycle 1/Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        44
        value
        75.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        160
      units
      Participants
    title
    Cycle 2/Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      325
    units
    Participants
description
Ctrough was defined as steady-state predose concentration. Observed directly from data. For palbociclib, a steady-state trough was to be defined as a predose plasma concentration following at least 8 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 22 and 26 hours after the dose (the day prior to PK collection) and no more than 1 hour post-dose on the day of PK collection.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
    id
    OG000
    title
    Palbociclib + Fulvestrant
param Type
GEOMETRIC_MEAN
population Description
The participants who were treated with Palbociclib + fulvestrant (with or without goserelin) or placebo + fulvestrant (with or without goserelin) and have at least one measured plasma drug concentration. The geometric mean and coefficient of variation was not estimable for Cycle 1/Day 15 and Cycle 2/Day 15 for the reporting arm placebo plus fulvestrant.
reporting Status
POSTED
time Frame
Cycle 1/Day 15 and Cycle 2/Day 15
title
Observed Plasma Trough Concentration (Ctrough) for Palbociclib
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice