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NCT03043313 · OUTCOME

Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): 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

The following chemistry laboratory parameters were assessed: Potassium increased; potassium decreased; aspartate aminotransferase increased; creatinine increased; alkaline phosphatase increased; total bilirubin increased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v5.0 was used for creatinine increased. NCI CTCAE v4.03 was used for the other laboratory parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.

Analysis population: The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

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)85
Tucatinib Pre-Crossover (Cohort C)29

Reported measurements

Potassium increased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)5Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)1Not reportedNot reportedNot reportedNot reported
Potassium increased, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)1Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Potassium increased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)1Not reportedNot reportedNot reportedNot reported
Potassium increased, Grade 4
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
Potassium decreased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)13Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)3Not reportedNot reportedNot reportedNot reported
Potassium decreased, Grade 2
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
Potassium decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)1Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)1Not reportedNot reportedNot reportedNot reported
Potassium decreased, Grade 4
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
Aspartate Aminotransferase increased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)20Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)6Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase increased, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)3Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase increased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)2Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)2Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase increased, Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)3Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase increased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)31Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)4Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase increased, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)4Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)2Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase increased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)2Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)2Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase increased, Grade 4
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
Creatinine increased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)38Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)9Not reportedNot reportedNot reportedNot reported
Creatinine increased, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)11Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Creatinine increased, Grade 3
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
Creatinine increased, Grade 4
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
Alkaline Phosphatase increased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)16Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)4Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase increased, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)4Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)2Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase increased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)1Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase increased, Grade 4
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
Total Bilirubin increased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)14Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)6Not reportedNot reportedNot reportedNot reported
Total Bilirubin increased, Grade 2
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
Total Bilirubin increased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)3Not reportedNot reportedNot reportedNot reported
Tucatinib Pre-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Total Bilirubin increased, Grade 4
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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
    title
    Potassium increased, Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Potassium increased, Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Potassium increased, Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Potassium increased, Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        3
    title
    Potassium decreased, Grade 1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Potassium decreased, Grade 2
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Potassium decreased, Grade 3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Potassium decreased, Grade 4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        6
    title
    Aspartate Aminotransferase increased, Grade 1
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Aspartate Aminotransferase increased, Grade 2
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Aspartate Aminotransferase increased, Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Aspartate Aminotransferase increased, Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      29
    units
    Participants
description
The following chemistry laboratory parameters were assessed: Potassium increased; potassium decreased; aspartate aminotransferase increased; creatinine increased; alkaline phosphatase increased; total bilirubin increased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v5.0 was used for creatinine increased. NCI CTCAE v4.03 was used for the other laboratory parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
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 all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to 49.3 months
title
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice