TriangleNCT03685591 · OUTCOME
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06952229 (Part 1B)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*hr/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 1 and cycle 2
What was measured
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity.
Analysis population: Participants with mCRPC, conducted dose escalation of PF-06952229 in combination with enzalutamide, who had sufficient information to estimate at least 1 of the PK parameters of interest and contributed to the summary statistics for AUCinf. AUCinf can be evaluated only when a well characterized terminal phase was observed, which is defined as one with at least 3 data points, r\^2≥0.9, and AUCextrap%≤20. Here, "number analyzed" signifies participant evaluable for each row.
Groups in this outcome
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 1B: PF-06952229 250mg + Enzalutamide | 2 |
| Part 1B: PF-06952229 375mg + Enzalutamide | 2 |
Reported measurements
Cycle 1 Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 17100 | 1 | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 14750 | 61 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 5095 | 75 | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 6214 | 3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1
- value
- 17100
- group Id
- OG001
- spread
- 61
- value
- 14750
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 75
- value
- 5095
- group Id
- OG001
- spread
- 3
- value
- 6214
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- 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
- OG000
- 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
- OG001
- title
- Part 1B: PF-06952229 375mg + Enzalutamide
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants with mCRPC, conducted dose escalation of PF-06952229 in combination with enzalutamide, who had sufficient information to estimate at least 1 of the PK parameters of interest and contributed to the summary statistics for AUCinf. AUCinf can be evaluated only when a well characterized terminal phase was observed, which is defined as one with at least 3 data points, r\^2≥0.9, and AUCextrap%≤20. Here, "number analyzed" signifies participant evaluable for each row.
- reporting Status
- POSTED
- time Frame
- 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 1 and cycle 2
- title
- Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06952229 (Part 1B)
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice