TriangleNCT04466891 · OUTCOME
Trough Concentration of ZW25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- micrograms per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose
What was measured
Minimum observed serum concentration (trough)
Analysis population: All subjects who received any amount of zanidatamab and have at least 1 post-baseline pharmacokinetic (PK) assessment were included in this outcome.
Groups in this outcome
Cohort I
Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+
Cohort II
Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.
| Group | Source count |
|---|---|
| Cohort I | 80 |
| Cohort II | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort I | 73.4 | 42.10 | Not reported | Not reported | Not reported |
| Cohort II | 46.5 | 18.66 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 42.10
- value
- 73.4
- group Id
- OG001
- spread
- 18.66
- value
- 46.5
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Minimum observed serum concentration (trough)
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+
- id
- OG000
- title
- Cohort I
- description
- Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.
- id
- OG001
- title
- Cohort II
- param Type
- GEOMETRIC_MEAN
- population Description
- All subjects who received any amount of zanidatamab and have at least 1 post-baseline pharmacokinetic (PK) assessment were included in this outcome.
- reporting Status
- POSTED
- time Frame
- Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose
- title
- Trough Concentration of ZW25
- type
- SECONDARY
- unit Of Measure
- micrograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice