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NCT01945775 · OUTCOME

Trough Plasma Talazoparib Concentrations

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) · Source last updated 2022-01-20

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

Measure
GEOMETRIC_MEAN
Unit
Picogram per milliliter (pg/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose on Day 1 of Cycle 2, 3 and 4

What was measured

A predose PK sample was considered dose-compliant based on the following criteria: A participant must have received 21 consecutive days of 1 mg talazoparib without dosing interruption prior to sample collection; and the predose PK sample must have been collected 24 hours +/- 10 percent (2 hours and 24 minutes) after the previous day's dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection.

Analysis population: Analysis population included participants who received at least 1 dose of talazoparib and had dose compliant pharmacokinetic (PK) predose sample. Here, "number analyzed" signifies number of participants who were evaluable for the specified categories. This endpoint was not planned to be analyzed for the reporting arm "Physician's Choice Treatment".

Groups in this outcome

Talazoparib

Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 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
Talazoparib175

Reported measurements

Cycle 2 Day 1: Predose

Analysis denominator · Participants

GroupSource count
Talazoparib137
Values in Picogram per milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Talazoparib337076.9Not reportedNot reportedNot reported
Cycle 3 Day 1: Predose

Analysis denominator · Participants

GroupSource count
Talazoparib120
Values in Picogram per milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Talazoparib357049.9Not reportedNot reportedNot reported
Cycle 4 Day 1: Predose

Analysis denominator · Participants

GroupSource count
Talazoparib107
Values in Picogram per milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Talazoparib340048.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.9
        value
        3370
    denoms
    1. counts
      1. group Id
        OG000
        value
        137
      units
      Participants
    title
    Cycle 2 Day 1: Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.9
        value
        3570
    denoms
    1. counts
      1. group Id
        OG000
        value
        120
      units
      Participants
    title
    Cycle 3 Day 1: Predose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.4
        value
        3400
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      units
      Participants
    title
    Cycle 4 Day 1: Predose
denoms
  1. counts
    1. group Id
      OG000
      value
      175
    units
    Participants
description
A predose PK sample was considered dose-compliant based on the following criteria: A participant must have received 21 consecutive days of 1 mg talazoparib without dosing interruption prior to sample collection; and the predose PK sample must have been collected 24 hours +/- 10 percent (2 hours and 24 minutes) after the previous day's dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
    id
    OG000
    title
    Talazoparib
param Type
GEOMETRIC_MEAN
population Description
Analysis population included participants who received at least 1 dose of talazoparib and had dose compliant pharmacokinetic (PK) predose sample. Here, "number analyzed" signifies number of participants who were evaluable for the specified categories. This endpoint was not planned to be analyzed for the reporting arm "Physician's Choice Treatment".
reporting Status
POSTED
time Frame
Predose on Day 1 of Cycle 2, 3 and 4
title
Trough Plasma Talazoparib Concentrations
type
SECONDARY
unit Of Measure
Picogram per milliliter (pg/mL)

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

Preserved source evidence · Not medical advice