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
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). 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 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 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
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
86
Tucatinib Post-Crossover (Cohort C)
28
Reported measurements
Any TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
82
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
23
Not reported
Not reported
Not reported
Not reported
Tucatinib-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
64
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
15
Not reported
Not reported
Not reported
Not reported
Trastuzumab-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
59
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
13
Not reported
Not reported
Not reported
Not reported
More than or equal to (>=) Grade 3 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
35
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
9
Not reported
Not reported
Not reported
Not reported
Tucatinib-related >= grade 3 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
8
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
Trastuzumab-related >= grade 3 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
6
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
Any Treatment-Emergent Serious AE (TESAE)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
20
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
6
Not reported
Not reported
Not reported
Not reported
Tucatinib-related TESAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
3
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Trastuzumab-related TESAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
2
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
TEAE leading to death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Discontinuation of any study treatment due to TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
5
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
Discontinuation of tucatinib due to treatment-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
2
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
Discontinuation of tucatinib due to tucatinib-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
2
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
Discontinuation of trastuzumab due to treatment-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
1
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
1
Not reported
Not reported
Not reported
Not reported
Discontinuation of trastuzumab due to trastuzumab-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
82
group Id
OG001
value
23
title
Any TEAE
categories
measurements
group Id
OG000
value
64
group Id
OG001
value
15
title
Tucatinib-related TEAE
categories
measurements
group Id
OG000
value
59
group Id
OG001
value
13
title
Trastuzumab-related TEAE
categories
measurements
group Id
OG000
value
35
group Id
OG001
value
9
title
More than or equal to (>=) Grade 3 TEAE
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
2
title
Tucatinib-related >= grade 3 TEAE
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
title
Trastuzumab-related >= grade 3 TEAE
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
6
title
Any Treatment-Emergent Serious AE (TESAE)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
title
Tucatinib-related TESAE
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
title
Trastuzumab-related TESAE
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
TEAE leading to death
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
title
Discontinuation of any study treatment due to TEAE
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
title
Discontinuation of tucatinib due to treatment-related TEAE
denoms
counts
group Id
OG000
value
86
group Id
OG001
value
28
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). 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 NCI CTCAE version 4.03: Grade(G) 3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE.
groups
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)
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 cohort A and B was combined as prespecified in SAP.
Triangle