TriangleNCT03685591 · OUTCOME
Apparent Clearance (CL/F) 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
- L/hr
- 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 and 21 of cycle 1, 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 2.
What was measured
Apparent Clearance After Oral Dose (CL/F) was defined as apparent clearance after oral dose on the last day of treatment period. CL/F = Dose/AUCinf for single dose; CL/F = Dose/AUCtau for steady-state. AUCtau was defined as Area under the plasma concentration-time profile from time zero to time tau (τ), the dosing interval, where τ = 24 and 12 hours for QD and BID dosing, respectively.
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 CL/F. CL/F 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 | 3 |
| Part 1B: PF-06952229 375mg + Enzalutamide | 3 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 2 |
| Part 1B: PF-06952229 375mg + Enzalutamide | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 14.65 | 0 | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 25.38 | 62 | Not reported | Not reported | Not reported |
Cycle 1 Day 21
| Group | Source count |
|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 3 |
| Part 1B: PF-06952229 375mg + Enzalutamide | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 30.86 | 26 | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 43.04 | 41 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 2 |
| Part 1B: PF-06952229 375mg + Enzalutamide | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 49.06 | 76 | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 60.39 | 3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 14.65
- group Id
- OG001
- spread
- 62
- value
- 25.38
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 26
- value
- 30.86
- group Id
- OG001
- spread
- 41
- value
- 43.04
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 21
- categories
- measurements
- group Id
- OG000
- spread
- 76
- value
- 49.06
- group Id
- OG001
- spread
- 3
- value
- 60.39
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Apparent Clearance After Oral Dose (CL/F) was defined as apparent clearance after oral dose on the last day of treatment period. CL/F = Dose/AUCinf for single dose; CL/F = Dose/AUCtau for steady-state. AUCtau was defined as Area under the plasma concentration-time profile from time zero to time tau (τ), the dosing interval, where τ = 24 and 12 hours for QD and BID dosing, respectively.
- 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 CL/F. CL/F 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 and 21 of cycle 1, 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 2.
- title
- Apparent Clearance (CL/F) of PF-06952229 (Part 1B)
- type
- SECONDARY
- unit Of Measure
- L/hr
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Preserved source evidence · Not medical advice