TriangleNCT04579380 · OUTCOME
Trough Concentration (Ctrough) of Tucatinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Nanogram per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 3 Day 1: Predose
Analysis population: The PK analysis set included all participants in the safety set from whom at least one evaluable PK assessment was reported.
Groups in this outcome
Tucatinib+Trastuzumab (Cohort 1)
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 2)
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 3)
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 4)
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 5)
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 6)
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 7)
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 9)
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
| Group | Source count |
|---|---|
| Tucatinib+Trastuzumab (Cohort 1) | 11 |
| Tucatinib+Trastuzumab (Cohort 2) | 27 |
| Tucatinib+Trastuzumab (Cohort 3) | 29 |
| Tucatinib+Trastuzumab (Cohort 4) | 22 |
| Tucatinib+Trastuzumab (Cohort 5) | 12 |
| Tucatinib+Trastuzumab (Cohort 6) | 27 |
| Tucatinib+Trastuzumab (Cohort 7) | 13 |
| Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) | 30 |
| Tucatinib+Trastuzumab (Cohort 9) | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib+Trastuzumab (Cohort 1) | 196.6 | 100.1 | Not reported | Not reported | Not reported |
| Tucatinib+Trastuzumab (Cohort 2) | 99.9 | 482.9 | Not reported | Not reported | Not reported |
| Tucatinib+Trastuzumab (Cohort 3) | 145.7 | 383.0 | Not reported | Not reported | Not reported |
| Tucatinib+Trastuzumab (Cohort 4) | 105.1 | 355.1 | Not reported | Not reported | Not reported |
| Tucatinib+Trastuzumab (Cohort 5) | 46.5 | 3312.4 | Not reported | Not reported | Not reported |
| Tucatinib+Trastuzumab (Cohort 6) | 115.4 | 328.3 | Not reported | Not reported | Not reported |
| Tucatinib+Trastuzumab (Cohort 7) | 267.4 | 165.2 | Not reported | Not reported | Not reported |
| Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) | 126.9 | 234.5 | Not reported | Not reported | Not reported |
| Tucatinib+Trastuzumab (Cohort 9) | 142.3 | 184.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 100.1
- value
- 196.6
- group Id
- OG001
- spread
- 482.9
- value
- 99.9
- group Id
- OG002
- spread
- 383.0
- value
- 145.7
- group Id
- OG003
- spread
- 355.1
- value
- 105.1
- group Id
- OG004
- spread
- 3312.4
- value
- 46.5
- group Id
- OG005
- spread
- 328.3
- value
- 115.4
- group Id
- OG006
- spread
- 165.2
- value
- 267.4
- group Id
- OG007
- spread
- 234.5
- value
- 126.9
- group Id
- OG008
- spread
- 184.1
- value
- 142.3
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 27
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 30
- group Id
- OG008
- value
- 29
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG000
- title
- Tucatinib+Trastuzumab (Cohort 1)
- description
- Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG001
- title
- Tucatinib+Trastuzumab (Cohort 2)
- description
- Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG002
- title
- Tucatinib+Trastuzumab (Cohort 3)
- description
- Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG003
- title
- Tucatinib+Trastuzumab (Cohort 4)
- description
- Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG004
- title
- Tucatinib+Trastuzumab (Cohort 5)
- description
- Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG005
- title
- Tucatinib+Trastuzumab (Cohort 6)
- description
- Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG006
- title
- Tucatinib+Trastuzumab (Cohort 7)
- description
- Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG007
- title
- Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
- description
- Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG008
- title
- Tucatinib+Trastuzumab (Cohort 9)
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set included all participants in the safety set from whom at least one evaluable PK assessment was reported.
- reporting Status
- POSTED
- time Frame
- Cycle 3 Day 1: Predose
- title
- Trough Concentration (Ctrough) of Tucatinib
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice