TriangleNCT01536145 · OUTCOME
Single Dose Systemic Clearance (CL) for CP-751,871
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- milliliter/day/kilogram (mL/day/kg)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Analysis population: All participants treated who had at least 1 of the PK parameters of primary interest.
Groups in this outcome
CP-751,871 0.2 mg/kg
CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 0.4 mg/kg
CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 0.8 mg/kg
CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 1.5 mg/kg
CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 3 mg/kg
CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
CP-751,871 6 mg/kg
CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 10 mg/kg
CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
| Group | Source count |
|---|---|
| CP-751,871 0.2 mg/kg | 3 |
| CP-751,871 0.4 mg/kg | 4 |
| CP-751,871 0.8 mg/kg | 3 |
| CP-751,871 1.5 mg/kg | 2 |
| CP-751,871 3 mg/kg | 3 |
| CP-751,871 6 mg/kg | 3 |
| CP-751,871 10 mg/kg | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CP-751,871 0.2 mg/kg | 19.7 | 3.65 | Not reported | Not reported | Not reported |
| CP-751,871 0.4 mg/kg | 11.9 | 8.75 | Not reported | Not reported | Not reported |
| CP-751,871 0.8 mg/kg | 10.9 | 5.09 | Not reported | Not reported | Not reported |
| CP-751,871 1.5 mg/kg | 3.57 | NA | Not reported | Not reported | Number of participants analyzed was less than 3, thus standard deviation was not calculated. |
| CP-751,871 3 mg/kg | 4.98 | 1.14 | Not reported | Not reported | Not reported |
| CP-751,871 6 mg/kg | 4.50 | 0.602 | Not reported | Not reported | Not reported |
| CP-751,871 10 mg/kg | 5.71 | 1.83 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.65
- value
- 19.7
- group Id
- OG001
- spread
- 8.75
- value
- 11.9
- group Id
- OG002
- spread
- 5.09
- value
- 10.9
- comment
- Number of participants analyzed was less than 3, thus standard deviation was not calculated.
- group Id
- OG003
- spread
- NA
- value
- 3.57
- group Id
- OG004
- spread
- 1.14
- value
- 4.98
- group Id
- OG005
- spread
- 0.602
- value
- 4.50
- group Id
- OG006
- spread
- 1.83
- value
- 5.71
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 5
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG000
- title
- CP-751,871 0.2 mg/kg
- description
- CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG001
- title
- CP-751,871 0.4 mg/kg
- description
- CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG002
- title
- CP-751,871 0.8 mg/kg
- description
- CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG003
- title
- CP-751,871 1.5 mg/kg
- description
- CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
- id
- OG004
- title
- CP-751,871 3 mg/kg
- description
- CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG005
- title
- CP-751,871 6 mg/kg
- description
- CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG006
- title
- CP-751,871 10 mg/kg
- param Type
- MEAN
- population Description
- All participants treated who had at least 1 of the PK parameters of primary interest.
- reporting Status
- POSTED
- time Frame
- Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
- title
- Single Dose Systemic Clearance (CL) for CP-751,871
- type
- SECONDARY
- unit Of Measure
- milliliter/day/kilogram (mL/day/kg)
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Preserved source evidence · Not medical advice