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NCT02614794 · OUTCOME

Pharmacokinetic Measure: Ctrough of Tucatinib

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer · Source last updated 2023-08-14

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
3.5 months

What was measured

Individual plasma tucatinib concentrations at each sampling time

Analysis population: Pharmacokinetics (PK) Analysis Set: Includes all randomized participants who received at least one dose of tucatinib and who had at least one evaluable PK assessment. Participants were evaluated by the treatment actually received.

Groups in this outcome

Tuc+Cap+Tra

Tucatinib in combination with capecitabine \& trastuzumab

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

Analysis denominator · Participants

GroupSource count
Tuc+Cap+Tra373

Reported measurements

Cycle 2, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra246.1260.9Not reportedNot reportedNot reported
Cycle 3, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra227.6210.8Not reportedNot reportedNot reported
Cycle 3, Day 1 (Post-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra507.1357.1Not reportedNot reportedNot reported
Cycle 4, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra253.2236.1Not reportedNot reportedNot reported
Cycle 5, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra257.6286.9Not reportedNot reportedNot reported
Cycle 6, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra247.8225.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        260.9
        value
        246.1
    title
    Cycle 2, Day 1 (Pre-dose)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        210.8
        value
        227.6
    title
    Cycle 3, Day 1 (Pre-dose)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        357.1
        value
        507.1
    title
    Cycle 3, Day 1 (Post-dose)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        236.1
        value
        253.2
    title
    Cycle 4, Day 1 (Pre-dose)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        286.9
        value
        257.6
    title
    Cycle 5, Day 1 (Pre-dose)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        225.1
        value
        247.8
    title
    Cycle 6, Day 1 (Pre-dose)
denoms
  1. counts
    1. group Id
      OG000
      value
      373
    units
    Participants
description
Individual plasma tucatinib concentrations at each sampling time
dispersion Type
Standard Deviation
groups
  1. description
    Tucatinib in combination with capecitabine \& trastuzumab
    id
    OG000
    title
    Tuc+Cap+Tra
param Type
MEAN
population Description
Pharmacokinetics (PK) Analysis Set: Includes all randomized participants who received at least one dose of tucatinib and who had at least one evaluable PK assessment. Participants were evaluated by the treatment actually received.
reporting Status
POSTED
time Frame
3.5 months
title
Pharmacokinetic Measure: Ctrough of Tucatinib
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice