TriangleNCT03685591 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) 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
- nanograms/milliliter (ng/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 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
Cmax was directly observed from data. Cmax was defined as maximum observed plasma concentration.
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 pharmacokinetic (PK) parameters of interest. 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 | 5 |
| Part 1A: PF-06952229 250mg Monotherapy | 13 |
| Part 1A: PF-06952229 375mg Monotherapy | 17 |
| Part 1A: PF-06952229 500mg Monotherapy | 4 |
Reported measurements
Cycle 1 Day 1
| 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 | 13 |
| Part 1A: PF-06952229 375mg Monotherapy | 17 |
| Part 1A: PF-06952229 500mg Monotherapy | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 203.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 215.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 345.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 509.7 | 173 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 1148 | 65 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 1782 | 117 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 1309 | 309 | 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 | 222.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 255.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 618.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 1050 | 85 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 1787 | 131 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 2727 | 98 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 2917 | 88 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| 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 | 12 |
| Part 1A: PF-06952229 500mg Monotherapy | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 128.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 240.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 200.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 696.0 | 112 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 1019 | 158 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 1876 | 95 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 2434 | 137 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 203.0
- group Id
- OG001
- value
- 215.0
- group Id
- OG002
- value
- 345.0
- group Id
- OG003
- spread
- 173
- value
- 509.7
- group Id
- OG004
- spread
- 65
- value
- 1148
- group Id
- OG005
- spread
- 117
- value
- 1782
- group Id
- OG006
- spread
- 309
- value
- 1309
- 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
- 13
- group Id
- OG005
- value
- 17
- group Id
- OG006
- value
- 4
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 222.0
- group Id
- OG001
- value
- 255.0
- group Id
- OG002
- value
- 618.0
- group Id
- OG003
- spread
- 85
- value
- 1050
- group Id
- OG004
- spread
- 131
- value
- 1787
- group Id
- OG005
- spread
- 98
- value
- 2727
- group Id
- OG006
- spread
- 88
- value
- 2917
- 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
- OG000
- value
- 128.0
- group Id
- OG001
- value
- 240.0
- group Id
- OG002
- value
- 200.0
- group Id
- OG003
- spread
- 112
- value
- 696.0
- group Id
- OG004
- spread
- 158
- value
- 1019
- group Id
- OG005
- spread
- 95
- value
- 1876
- group Id
- OG006
- spread
- 137
- value
- 2434
- 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
- 12
- group Id
- OG006
- value
- 4
- 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
- 5
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 17
- group Id
- OG006
- value
- 4
- units
- Participants
- description
- Cmax was directly observed from data. Cmax was defined as maximum observed plasma concentration.
- 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 pharmacokinetic (PK) parameters of interest. 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
- Maximum Observed Plasma Concentration (Cmax) of PF-06952229 (Part 1A)
- type
- SECONDARY
- unit Of Measure
- nanograms/milliliter (ng/mL)
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Preserved source evidence · Not medical advice