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NCT03043313 · OUTCOME

Number of Participants With AEs Resulting in Dose Modification: Final Analysis

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer · Source last updated 2024-11-26

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 65.1 months

What was measured

Dose modification included dose reduction and dose withheld by investigator due to AEs. Dose holds were defined as any instances where planned administration of the study drug was temporarily withheld or interrupted at the direction of the treating physician. Dose reductions of trastuzumab were not allowed; if trastuzumab could not be restarted after being held for a TEAE, it was discontinued. Drug interruption included infusion interrupted (full dose received within 24hrs).

Analysis population: The safety analysis set included participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP.

Groups in this outcome

Tucatinib+Trastuzumab (Cohorts A+B)

Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.

Tucatinib Post-Crossover (Cohort C)

Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.

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

Analysis denominator · Participants

GroupSource count
Tucatinib+Trastuzumab (Cohorts A+B)86
Tucatinib Post-Crossover (Cohort C)28

Reported measurements

Tucatinib dose held
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)23Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)7Not reportedNot reportedNot reportedNot reported
Tucatinib dose reduced
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)9Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)2Not reportedNot reportedNot reportedNot reported
Trastuzumab dose held
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)27Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)2Not reportedNot reportedNot reportedNot reported
Trastuzumab infusion interrupted
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)6Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        7
    title
    Tucatinib dose held
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        2
    title
    Tucatinib dose reduced
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        2
    title
    Trastuzumab dose held
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
    title
    Trastuzumab infusion interrupted
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    2. group Id
      OG001
      value
      28
    units
    Participants
description
Dose modification included dose reduction and dose withheld by investigator due to AEs. Dose holds were defined as any instances where planned administration of the study drug was temporarily withheld or interrupted at the direction of the treating physician. Dose reductions of trastuzumab were not allowed; if trastuzumab could not be restarted after being held for a TEAE, it was discontinued. Drug interruption included infusion interrupted (full dose received within 24hrs).
groups
  1. description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    OG000
    title
    Tucatinib+Trastuzumab (Cohorts A+B)
  2. description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    OG001
    title
    Tucatinib Post-Crossover (Cohort C)
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set included participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP.
reporting Status
POSTED
time Frame
Up to 65.1 months
title
Number of Participants With AEs Resulting in Dose Modification: Final Analysis
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice