TriangleNCT03685591 · OUTCOME
Percentage of Participants With Objective Response
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
- Baseline and every 8 to 12 weeks through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.
What was measured
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). Complete response was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). All target lesions must be assessed. Partial response was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.
Analysis population: Population included all enrolled participants who received at least 1 dose of investigational product, had baseline assessment and at least 1 post baseline assessment, disease progression, or death before the first tumor assessment.
Groups in this outcome
Part 1A: PF-06952229 20mg Monotherapy
PF-06952229 was administered at a dose of 20 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 40mg Monotherapy
PF-06952229 was administered at a dose of 40 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 80mg Monotherapy
PF-06952229 was administered at a dose of 80 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 150mg Monotherapy
PF-06952229 was administered at a dose of 150 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 250mg Monotherapy
PF-06952229 was administered at a dose of 250 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 375mg Monotherapy
PF-06952229 was administered at a dose of 375 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 500mg Monotherapy
PF-06952229 was administered at a dose of 500 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1B: PF-06952229 250mg + Enzalutamide
PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
Part 1B: PF-06952229 375mg + Enzalutamide
PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
| Group | Source count |
|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 1 |
| Part 1A: PF-06952229 40mg Monotherapy | 1 |
| Part 1A: PF-06952229 80mg Monotherapy | 1 |
| Part 1A: PF-06952229 150mg Monotherapy | 5 |
| Part 1A: PF-06952229 250mg Monotherapy | 10 |
| Part 1A: PF-06952229 375mg Monotherapy | 14 |
| Part 1A: PF-06952229 500mg Monotherapy | 4 |
| Part 1B: PF-06952229 250mg + Enzalutamide | 4 |
| Part 1B: PF-06952229 375mg + Enzalutamide | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 | Not reported | 0.0 | 97.5 | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 0 | Not reported | 0.0 | 97.5 | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 0 | Not reported | 0.0 | 97.5 | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 0 | Not reported | 0.0 | 52.2 | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 0 | Not reported | 0.0 | 30.8 | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 7.1 | Not reported | 0.2 | 33.9 | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 0 | Not reported | 0.0 | 60.2 | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 0 | Not reported | 0.0 | 60.2 | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 0 | Not reported | 0.0 | 84.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 97.5
- value
- 0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 97.5
- value
- 0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 97.5
- value
- 0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 30.8
- value
- 0
- group Id
- OG005
- lower Limit
- 0.2
- upper Limit
- 33.9
- value
- 7.1
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0
- group Id
- OG008
- lower Limit
- 0.0
- upper Limit
- 84.2
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 2
- units
- Participants
- description
- Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). Complete response was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). All target lesions must be assessed. Partial response was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- PF-06952229 was administered at a dose of 20 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG000
- title
- Part 1A: PF-06952229 20mg Monotherapy
- description
- PF-06952229 was administered at a dose of 40 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG001
- title
- Part 1A: PF-06952229 40mg Monotherapy
- description
- PF-06952229 was administered at a dose of 80 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG002
- title
- Part 1A: PF-06952229 80mg Monotherapy
- description
- PF-06952229 was administered at a dose of 150 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG003
- title
- Part 1A: PF-06952229 150mg Monotherapy
- description
- PF-06952229 was administered at a dose of 250 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG004
- title
- Part 1A: PF-06952229 250mg Monotherapy
- description
- PF-06952229 was administered at a dose of 375 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG005
- title
- Part 1A: PF-06952229 375mg Monotherapy
- description
- PF-06952229 was administered at a dose of 500 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG006
- title
- Part 1A: PF-06952229 500mg Monotherapy
- description
- PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
- id
- OG007
- title
- Part 1B: PF-06952229 250mg + Enzalutamide
- description
- PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
- id
- OG008
- title
- Part 1B: PF-06952229 375mg + Enzalutamide
- param Type
- NUMBER
- population Description
- Population included all enrolled participants who received at least 1 dose of investigational product, had baseline assessment and at least 1 post baseline assessment, disease progression, or death before the first tumor assessment.
- reporting Status
- POSTED
- time Frame
- Baseline and every 8 to 12 weeks through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.
- title
- Percentage of Participants With Objective Response
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice