TriangleNCT03685591 · OUTCOME
Apparent Volume of Distribution (Vz/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 (L)
- 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
Vz/F was defined as apparent volume of distribution. Vz/F = Dose / (AUCinf\* kel) for single dose; Vz/F = Dose / (AUCtau\* kel) 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. Kel was defined as terminal phase rate constant.
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 Vz/F. Vz/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 | 0 |
| Part 1A: PF-06952229 40mg Monotherapy | 1 |
| 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 |
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 | 187.2 | 31 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 178.1 | 46 | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 130.0 | Not reported | Not reported | Not reported | Not reported |
Cycle 1 Day 7
| Group | Source count |
|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 |
| Part 1A: PF-06952229 40mg Monotherapy | 1 |
| 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 | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 40mg Monotherapy | 139.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 287.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 665.0 | Not reported | 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 | 266.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG004
- spread
- 31
- value
- 187.2
- group Id
- OG005
- spread
- 46
- value
- 178.1
- group Id
- OG006
- value
- 130.0
- 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
- OG001
- value
- 139.0
- group Id
- OG005
- value
- 287.0
- group Id
- OG006
- value
- 665.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 7
- categories
- measurements
- group Id
- OG005
- value
- 266.0
- 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
- 0
- group Id
- OG001
- value
- 1
- 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
- description
- Vz/F was defined as apparent volume of distribution. Vz/F = Dose / (AUCinf\* kel) for single dose; Vz/F = Dose / (AUCtau\* kel) 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. Kel was defined as terminal phase rate constant.
- 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 Vz/F. Vz/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 Volume of Distribution (Vz/F) of PF-06952229 (Part 1A)
- type
- SECONDARY
- unit Of Measure
- liter (L)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice