TriangleNCT05061537 · OUTCOME
Part 1: Time to Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From start date of treatment to the date of first documentation of PD (up to maximum follow-up of 10.45 months)
What was measured
Time to progression was defined as the time from start date of treatment to the date of the first documentation of PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. 95% CI was based on Brookmeyer and Crowley method.
Analysis population: Full analysis set included all enrolled participants. 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 | 1.4 | Not reported | 1.4 | NA | Upper limit of 95% CI could not be calculated due to insufficient number of participants with events. |
| Part 1A PF-07263689 6*10^8 PFU | 1.5 | Not reported | 1.3 | NA | Upper limit of 95% CI could not be calculated due to insufficient number of participants with events. |
| Part 1A PF-07263689 20*10^8PFU | 1.4 | Not reported | 1.4 | NA | Upper limit of 95% CI could not be calculated due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 1.4
- comment
- Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- NA
- value
- 1.5
- comment
- Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Time to progression was defined as the time from start date of treatment to the date of the first documentation of PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. 95% CI was based on Brookmeyer and Crowley method.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Full analysis set included all enrolled participants. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
- reporting Status
- POSTED
- time Frame
- From start date of treatment to the date of first documentation of PD (up to maximum follow-up of 10.45 months)
- title
- Part 1: Time to Progression
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice