TriangleNCT03685591 · OUTCOME
Time of Observed Maximum Plasma Concentration (Tmax) of PF-06952229 (Part 1A)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour (hr)
- Interval / dispersion
- Full Range
- 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
Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.
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 | 2.10 | Not reported | 2.10 | 2.10 | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 3.83 | Not reported | 3.83 | 3.83 | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 2.00 | Not reported | 2.00 | 2.00 | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 2.15 | Not reported | 1.08 | 5.83 | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 2.17 | Not reported | 1.00 | 9.00 | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 2.03 | Not reported | 0.950 | 9.00 | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 1.97 | Not reported | 1.00 | 2.12 | 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 | 0.967 | Not reported | 0.967 | 0.967 | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 2.05 | Not reported | 2.05 | 2.05 | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 2.18 | Not reported | 2.18 | 2.18 | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 1.51 | Not reported | 0.450 | 2.38 | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 2.00 | Not reported | 0 | 3.90 | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 1.92 | Not reported | 0.850 | 4.33 | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 1.48 | Not reported | 1.00 | 2.00 | 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 | 3.95 | Not reported | 3.95 | 3.95 | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 6.08 | Not reported | 6.08 | 6.08 | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 5.52 | Not reported | 5.52 | 5.52 | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 5.99 | Not reported | 1.00 | 6.03 | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 4.14 | Not reported | 1.03 | 5.93 | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 5.02 | Not reported | 1.00 | 9.08 | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 3.65 | Not reported | 2.00 | 9.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.10
- upper Limit
- 2.10
- value
- 2.10
- group Id
- OG001
- lower Limit
- 3.83
- upper Limit
- 3.83
- value
- 3.83
- group Id
- OG002
- lower Limit
- 2.00
- upper Limit
- 2.00
- value
- 2.00
- group Id
- OG003
- lower Limit
- 1.08
- upper Limit
- 5.83
- value
- 2.15
- group Id
- OG004
- lower Limit
- 1.00
- upper Limit
- 9.00
- value
- 2.17
- group Id
- OG005
- lower Limit
- 0.950
- upper Limit
- 9.00
- value
- 2.03
- group Id
- OG006
- lower Limit
- 1.00
- upper Limit
- 2.12
- value
- 1.97
- 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
- lower Limit
- 0.967
- upper Limit
- 0.967
- value
- 0.967
- group Id
- OG001
- lower Limit
- 2.05
- upper Limit
- 2.05
- value
- 2.05
- group Id
- OG002
- lower Limit
- 2.18
- upper Limit
- 2.18
- value
- 2.18
- group Id
- OG003
- lower Limit
- 0.450
- upper Limit
- 2.38
- value
- 1.51
- group Id
- OG004
- lower Limit
- 0
- upper Limit
- 3.90
- value
- 2.00
- group Id
- OG005
- lower Limit
- 0.850
- upper Limit
- 4.33
- value
- 1.92
- group Id
- OG006
- lower Limit
- 1.00
- upper Limit
- 2.00
- value
- 1.48
- 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
- lower Limit
- 3.95
- upper Limit
- 3.95
- value
- 3.95
- group Id
- OG001
- lower Limit
- 6.08
- upper Limit
- 6.08
- value
- 6.08
- group Id
- OG002
- lower Limit
- 5.52
- upper Limit
- 5.52
- value
- 5.52
- group Id
- OG003
- lower Limit
- 1.00
- upper Limit
- 6.03
- value
- 5.99
- group Id
- OG004
- lower Limit
- 1.03
- upper Limit
- 5.93
- value
- 4.14
- group Id
- OG005
- lower Limit
- 1.00
- upper Limit
- 9.08
- value
- 5.02
- group Id
- OG006
- lower Limit
- 2.00
- upper Limit
- 9.00
- value
- 3.65
- 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
- Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.
- dispersion Type
- Full Range
- 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
- MEDIAN
- 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 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
- Time of Observed Maximum Plasma Concentration (Tmax) of PF-06952229 (Part 1A)
- type
- SECONDARY
- unit Of Measure
- hour (hr)
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Preserved source evidence · Not medical advice