TriangleNCT04628780 · OUTCOME
Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From start of the treatment until disease progression or discontinuation from study or death due to any cause, whichever occurred first (maximum up to 14.5 months)
What was measured
Objective Response Rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis \<10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-progressive disease (PD), where PD is unequivocal progression of pre-existing lesions.
Analysis population: Response evaluable set included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
Groups in this outcome
PF-07209960 1 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
PF-07209960 3 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
PF-07209960 10 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
PF-07209960 15 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
PF-07209960 20 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
PF-07209960 30 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
| Group | Source count |
|---|---|
| PF-07209960 1 mg SC | 3 |
| PF-07209960 3 mg SC | 4 |
| PF-07209960 10 mg SC | 3 |
| PF-07209960 15 mg SC | 3 |
| PF-07209960 20 mg SC | 11 |
| PF-07209960 30 mg SC | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-07209960 1 mg SC | 0 | Not reported | 0.0 | 70.8 | Not reported |
| PF-07209960 3 mg SC | 0 | Not reported | 0.0 | 60.2 | Not reported |
| PF-07209960 10 mg SC | 0 | Not reported | 0.0 | 70.8 | Not reported |
| PF-07209960 15 mg SC | 0 | Not reported | 0.0 | 70.8 | Not reported |
| PF-07209960 20 mg SC | 9.1 | Not reported | 0.2 | 41.3 | Not reported |
| PF-07209960 30 mg SC | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0
- group Id
- OG004
- lower Limit
- 0.2
- upper Limit
- 41.3
- value
- 9.1
- group Id
- OG005
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 5
- units
- Participants
- description
- Objective Response Rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis \<10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-progressive disease (PD), where PD is unequivocal progression of pre-existing lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
- id
- OG000
- title
- PF-07209960 1 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
- id
- OG001
- title
- PF-07209960 3 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
- id
- OG002
- title
- PF-07209960 10 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
- id
- OG003
- title
- PF-07209960 15 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
- id
- OG004
- title
- PF-07209960 20 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
- id
- OG005
- title
- PF-07209960 30 mg SC
- param Type
- NUMBER
- population Description
- Response evaluable set included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- From start of the treatment until disease progression or discontinuation from study or death due to any cause, whichever occurred first (maximum up to 14.5 months)
- title
- Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice