Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03043313 · OUTCOME

Number of Participants With Adverse Events (AEs): Interim 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 49.3 months

What was measured

AE: Any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs): Events that were new or worsened on or after receiving the first dose of study treatment (tucatinib or trastuzumab) and up through 30 days after the last dose of study treatment (tucatinib or trastuzumab). Serious AE (SAE): An event that at any dose led to death; life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Relatedness was judged by investigator According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G) 3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE.

Analysis population: The safety analysis set included participants who received any amount of study treatment. Data for cohort 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 Pre-Crossover (Cohort C)

Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.

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 Pre-Crossover (Cohort C)30

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)82Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)28Not reportedNot reportedNot reportedNot reported
Tucatinib-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)63Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)22Not reportedNot reportedNot reportedNot reported
Trastuzumab-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)58Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)NANot reportedNot reportedNot reportedTucatinib monotherapy arm.
Any grade 3-5 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)33Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)8Not reportedNot reportedNot reportedNot reported
Trastuzumab-related grade 3-5 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)6Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)NANot reportedNot reportedNot reportedTucatinib monotherapy arm.
Tucatinib-related grade 3-5 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)8Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)2Not reportedNot reportedNot reportedNot reported
Any Treatment-Emergent Serious AE (TESAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)19Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)3Not reportedNot reportedNot reportedNot reported
Tucatinib-related TESAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)3Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)1Not reportedNot reportedNot reportedNot reported
Trastuzumab-related TESAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)2Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)NANot reportedNot reportedNot reportedTucatinib monotherapy arm.
TEAE leading to death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Discontinuation of any study treatment due to TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)5Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Discontinuation of tucatinib due to TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)5Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Discontinuation of tucatinib due to tucatinib-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)2Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Discontinuation of trastuzumab due to TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)3Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)NANot reportedNot reportedNot reportedTucatinib monotherapy arm.
Discontinuation of trastuzumab due to trastuzumab-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)NANot reportedNot reportedNot reportedTucatinib monotherapy arm.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        28
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        22
    title
    Tucatinib-related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      2. comment
        Tucatinib monotherapy arm.
        group Id
        OG001
        value
        NA
    title
    Trastuzumab-related TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        8
    title
    Any grade 3-5 TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. comment
        Tucatinib monotherapy arm.
        group Id
        OG001
        value
        NA
    title
    Trastuzumab-related grade 3-5 TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        2
    title
    Tucatinib-related grade 3-5 TEAE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        3
    title
    Any Treatment-Emergent Serious AE (TESAE)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    title
    Tucatinib-related TESAE
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. comment
        Tucatinib monotherapy arm.
        group Id
        OG001
        value
        NA
    title
    Trastuzumab-related TESAE
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    TEAE leading to death
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
    title
    Discontinuation of any study treatment due to TEAE
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
    title
    Discontinuation of tucatinib due to TEAE
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    2. group Id
      OG001
      value
      30
    units
    Participants
description
AE: Any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs): Events that were new or worsened on or after receiving the first dose of study treatment (tucatinib or trastuzumab) and up through 30 days after the last dose of study treatment (tucatinib or trastuzumab). Serious AE (SAE): An event that at any dose led to death; life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Relatedness was judged by investigator According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G) 3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE.
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. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
    id
    OG001
    title
    Tucatinib Pre-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 cohort A and B was combined as prespecified in SAP.
reporting Status
POSTED
time Frame
Up to 49.3 months
title
Number of Participants With Adverse Events (AEs): Interim Analysis
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice