TriangleNCT03685591 · OUTCOME
Number of Participants With Prostate Specific Antigen 50 (PSA50) Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, Cycle 1 Day 1 (at the beginning of Cycle 1), and then every 3 cycles (each cycle is 28 days) until end of treatment (an average of 1 year)
What was measured
Prostate-specific antigen decline by more than 50% from baseline was analyzed. PSA partial response was defined as a ≥50% decline in PSA from Cycle 1 Day 1 (baseline) PSA value. This PSA decline much be confirmed to be sustained by a second PSA value obtained 4 or more weeks later.
Analysis population: Population included all enrolled participants who had metastatic castration resistant prostate cancer (mCRPC)
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 | 1 |
| Part 1A: PF-06952229 250mg Monotherapy | 8 |
| 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 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 3
- units
- Participants
- description
- Prostate-specific antigen decline by more than 50% from baseline was analyzed. PSA partial response was defined as a ≥50% decline in PSA from Cycle 1 Day 1 (baseline) PSA value. This PSA decline much be confirmed to be sustained by a second PSA value obtained 4 or more weeks later.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Population included all enrolled participants who had metastatic castration resistant prostate cancer (mCRPC)
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 1 Day 1 (at the beginning of Cycle 1), and then every 3 cycles (each cycle is 28 days) until end of treatment (an average of 1 year)
- title
- Number of Participants With Prostate Specific Antigen 50 (PSA50) Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice