TriangleNCT03043313 · OUTCOME
Number of Participants With AEs Resulting in Dose Modification: Interim Analysis
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
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.
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 | Source count |
|---|---|
| Tucatinib+Trastuzumab (Cohorts A+B) | 86 |
| Tucatinib Pre-Crossover (Cohort C) | 30 |
Reported measurements
Tucatinib dose held
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib+Trastuzumab (Cohorts A+B) | 20 | Not reported | Not reported | Not reported | Not reported |
| Tucatinib Pre-Crossover (Cohort C) | 3 | Not reported | Not reported | Not reported | Not reported |
Tucatinib dose reduced
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib+Trastuzumab (Cohorts A+B) | 8 | Not reported | Not reported | Not reported | Not reported |
| Tucatinib Pre-Crossover (Cohort C) | 1 | Not reported | Not reported | Not reported | Not reported |
Trastuzumab dose held
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib+Trastuzumab (Cohorts A+B) | 24 | Not reported | Not reported | Not reported | Not reported |
| Tucatinib Pre-Crossover (Cohort C) | NA | Not reported | Not reported | Not reported | Tucatinib monotherapy arm. |
Trastuzumab infusion interrupted (received full dose within 24 hrs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib+Trastuzumab (Cohorts A+B) | 6 | Not reported | Not reported | Not reported | Not reported |
| Tucatinib Pre-Crossover (Cohort C) | NA | Not reported | Not reported | Not reported | Tucatinib monotherapy arm. |
Trastuzumab infusion stopped early (full dose not received)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib+Trastuzumab (Cohorts A+B) | 1 | Not reported | Not reported | Not reported | Not reported |
| Tucatinib Pre-Crossover (Cohort C) | NA | Not reported | Not reported | Not reported | Tucatinib monotherapy arm. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 3
- title
- Tucatinib dose held
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 1
- title
- Tucatinib dose reduced
- categories
- measurements
- group Id
- OG000
- value
- 24
- comment
- Tucatinib monotherapy arm.
- group Id
- OG001
- value
- NA
- title
- Trastuzumab dose held
- categories
- measurements
- group Id
- OG000
- value
- 6
- comment
- Tucatinib monotherapy arm.
- group Id
- OG001
- value
- NA
- title
- Trastuzumab infusion interrupted (received full dose within 24 hrs)
- categories
- measurements
- group Id
- OG000
- value
- 1
- comment
- Tucatinib monotherapy arm.
- group Id
- OG001
- value
- NA
- title
- Trastuzumab infusion stopped early (full dose not received)
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 30
- 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.
- 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. 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 AEs Resulting in Dose Modification: Interim Analysis
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice