TriangleNCT05061537 · OUTCOME
Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Copies per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)
Analysis population: Blood viral load Kinetics Analysis Set included all enrolled participants treated who did not have protocol deviations influencing viral load kinetics assessment, and had sufficient information to estimate at least 1 of the parameters of interest. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
Groups in this outcome
Part 1A PF-07263689 2*10^8 PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\*10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1A PF-07263689 6*10^8 PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1A PF-07263689 20*10^8PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
| Group | Source count |
|---|---|
| Part 1A PF-07263689 2*10^8 PFU | 3 |
| Part 1A PF-07263689 6*10^8 PFU | 4 |
| Part 1A PF-07263689 20*10^8PFU | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | NA | NA | Not reported | Not reported | Cmax could not be calculated as the values were below limit of quantification. |
| Part 1A PF-07263689 6*10^8 PFU | NA | NA | Not reported | Not reported | Cmax could not be calculated as the values were below limit of quantification. |
| Part 1A PF-07263689 20*10^8PFU | NA | NA | Not reported | Not reported | Cmax could not be calculated as the values were below limit of quantification. |
Complete source fields
- classes
- categories
- measurements
- comment
- Cmax could not be calculated as the values were below limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Cmax could not be calculated as the values were below limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Cmax could not be calculated as the values were below limit of quantification.
- group Id
- OG002
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\*10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- OG000
- title
- Part 1A PF-07263689 2*10^8 PFU
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- OG001
- title
- Part 1A PF-07263689 6*10^8 PFU
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- OG002
- title
- Part 1A PF-07263689 20*10^8PFU
- param Type
- GEOMETRIC_MEAN
- population Description
- Blood viral load Kinetics Analysis Set included all enrolled participants treated who did not have protocol deviations influencing viral load kinetics assessment, and had sufficient information to estimate at least 1 of the parameters of interest. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
- reporting Status
- POSTED
- time Frame
- Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)
- title
- Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood
- type
- SECONDARY
- unit Of Measure
- Copies per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice