TriangleNCT03685591 · OUTCOME
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) 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*hour/milliliter (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
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured 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 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 | 785.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 1010 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 1190 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 2726 | 136 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 5111 | 72 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 8470 | 133 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 6401 | 281 | 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 | 466.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 547.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 508.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 2035 | 42 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 3130 | 329 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 10050 | 97 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 10540 | 159 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 785.0
- group Id
- OG001
- value
- 1010
- group Id
- OG002
- value
- 1190
- group Id
- OG003
- spread
- 136
- value
- 2726
- group Id
- OG004
- spread
- 72
- value
- 5111
- group Id
- OG005
- spread
- 133
- value
- 8470
- group Id
- OG006
- spread
- 281
- value
- 6401
- 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
- 466.0
- group Id
- OG001
- value
- 547.0
- group Id
- OG002
- value
- 508.0
- group Id
- OG003
- spread
- 42
- value
- 2035
- group Id
- OG004
- spread
- 329
- value
- 3130
- group Id
- OG005
- spread
- 97
- value
- 10050
- group Id
- OG006
- spread
- 159
- value
- 10540
- 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
- AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured 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 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 of cycle 1 and cycle 2
- title
- Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of PF-06952229 (Part 1A)
- type
- SECONDARY
- unit Of Measure
- nanograms*hour/milliliter (ng*hr/mL)
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Preserved source evidence · Not medical advice