TriangleNCT03685591 · OUTCOME
Apparent Clearance (CL/F) of PF-06952229 (Part 1A)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- liter per hour (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 7 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 advanced/metastatic tumors in PF-06952229 single agent dose escalation phase, 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 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).
| 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 | 4 |
| Part 1A: PF-06952229 250mg Monotherapy | 6 |
| Part 1A: PF-06952229 375mg Monotherapy | 15 |
| Part 1A: PF-06952229 500mg Monotherapy | 4 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 |
| Part 1A: PF-06952229 40mg Monotherapy | 0 |
| Part 1A: PF-06952229 80mg Monotherapy | 0 |
| Part 1A: PF-06952229 150mg Monotherapy | 0 |
| Part 1A: PF-06952229 250mg Monotherapy | 2 |
| Part 1A: PF-06952229 375mg Monotherapy | 2 |
| Part 1A: PF-06952229 500mg Monotherapy | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 250mg Monotherapy | 50.23 | 32 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 36.86 | 43 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 27.10 | Not reported | Not reported | Not reported | Not reported |
Cycle 1 Day 7
| 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 | 4 |
| Part 1A: PF-06952229 250mg Monotherapy | 6 |
| Part 1A: PF-06952229 375mg Monotherapy | 15 |
| Part 1A: PF-06952229 500mg Monotherapy | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 9.850 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 21.80 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 22.30 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 17.36 | 79 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 15.95 | 127 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 19.49 | 92 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 29.04 | 132 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 |
| Part 1A: PF-06952229 40mg Monotherapy | 0 |
| Part 1A: PF-06952229 80mg Monotherapy | 0 |
| Part 1A: PF-06952229 150mg Monotherapy | 0 |
| Part 1A: PF-06952229 250mg Monotherapy | 0 |
| Part 1A: PF-06952229 375mg Monotherapy | 1 |
| Part 1A: PF-06952229 500mg Monotherapy | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 375mg Monotherapy | 55.00 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG004
- spread
- 32
- value
- 50.23
- group Id
- OG005
- spread
- 43
- value
- 36.86
- group Id
- OG006
- value
- 27.10
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 9.850
- group Id
- OG001
- value
- 21.80
- group Id
- OG002
- value
- 22.30
- group Id
- OG003
- spread
- 79
- value
- 17.36
- group Id
- OG004
- spread
- 127
- value
- 15.95
- group Id
- OG005
- spread
- 92
- value
- 19.49
- group Id
- OG006
- spread
- 132
- value
- 29.04
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 4
- units
- Participants
- title
- Cycle 1 Day 7
- categories
- measurements
- group Id
- OG005
- value
- 55.00
- denoms
- counts
- 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
- 1
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 4
- 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 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
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants with advanced/metastatic tumors in PF-06952229 single agent dose escalation phase, 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 7 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 1A)
- type
- SECONDARY
- unit Of Measure
- liter per hour (L/hr)
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Preserved source evidence · Not medical advice