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NCT02614794 · OUTCOME

Pharmacokinetic Measure: ONT-993

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 primary metabolite concentrations at each sampling time

Analysis population: 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+Tra25.524.4Not reportedNot reportedNot reported
Cycle 3, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra22.620.6Not reportedNot reportedNot reported
Cycle 3, Day 1 (Post-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra47.747.2Not reportedNot reportedNot reported
Cycle 4, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra25.224.3Not reportedNot reportedNot reported
Cycle 5, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra24.530.6Not reportedNot reportedNot reported
Cycle 6, Day 1 (Pre-dose)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra20.918.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.4
        value
        25.5
    title
    Cycle 2, Day 1 (Pre-dose)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.6
        value
        22.6
    title
    Cycle 3, Day 1 (Pre-dose)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.2
        value
        47.7
    title
    Cycle 3, Day 1 (Post-dose)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.3
        value
        25.2
    title
    Cycle 4, Day 1 (Pre-dose)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.6
        value
        24.5
    title
    Cycle 5, Day 1 (Pre-dose)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.0
        value
        20.9
    title
    Cycle 6, Day 1 (Pre-dose)
denoms
  1. counts
    1. group Id
      OG000
      value
      373
    units
    Participants
description
Individual plasma primary metabolite 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
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: ONT-993
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice